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<TITLE>의약품 등의 제조업 및 수입자의 시설기준령 시행규칙</TITLE>
<SUBJECT>본문</SUBJECT>
<AUTHOR>법제처 국가법령정보센터</AUTHOR>
<DATE></DATE> 
<KEYWORDS>법제처 국가법령정보센터</KEYWORDS>
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<RIGHTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<TOPBORDER Type="Solid" Width="0.12mm" Color="0"/>
<BOTTOMBORDER Type="Solid" Width="0.12mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.12mm" Color="0"/>
</BORDERFILL>
<BORDERFILL Id="28" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<RIGHTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<TOPBORDER Type="Solid" Width="0.4mm" Color="0"/>
<BOTTOMBORDER Type="Solid" Width="0.12mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.12mm" Color="0"/>
<FILLBRUSH><WINDOWBRUSH FaceColor="15198183" HatchColor="0"/>
</FILLBRUSH>
</BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="29" Shadow="false" Slash="0" ThreeD="false">
						<LEFTBORDER Type="Solid" Width="0.12mm"/>
						<RIGHTBORDER Type="Solid" Width="0.12mm"/>
						<TOPBORDER Type="Solid" Width="0.3mm"/>
						<BOTTOMBORDER Type="Solid" Width="0.12mm"/>
						<DIAGONAL Type="Solid" Width="0.12mm"/>
						<FILLBRUSH>
							<WINDOWBRUSH Alpha="0" FaceColor="14079702" HatchColor="0"/>
						</FILLBRUSH>
					</BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="30" Shadow="false" Slash="0" ThreeD="false">
						<LEFTBORDER Type="Solid" Width="0.12mm"/>
						<RIGHTBORDER Type="Solid" Width="0.12mm"/>
						<TOPBORDER Type="Solid" Width="0.12mm"/>
						<BOTTOMBORDER Type="Solid" Width="0.3mm"/>
						<DIAGONAL Type="Solid" Width="0.12mm"/>
					</BORDERFILL>
<BORDERFILL Id="31" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<RIGHTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<TOPBORDER Type="Solid" Width="0.12mm" Color="0"/>
<BOTTOMBORDER Type="Solid" Width="0.4mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.12mm" Color="0"/>
</BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="32" Shadow="false" Slash="0" ThreeD="false"><LEFTBORDER Type="Solid" Width="0.12mm"/><RIGHTBORDER Type="Solid" Width="0.12mm"/><TOPBORDER Type="None" Width="0.12mm"/><BOTTOMBORDER Type="None" Width="0.12mm"/><DIAGONAL Type="Solid" Width="0.12mm"/></BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="33" Shadow="false" Slash="0" ThreeD="false"><LEFTBORDER Type="Solid" Width="0.12mm"/><RIGHTBORDER Type="Solid" Width="0.12mm"/><TOPBORDER Type="Solid" Width="0.12mm"/><BOTTOMBORDER Type="None" Width="0.12mm"/><DIAGONAL Type="Solid" Width="0.12mm"/></BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="34" Shadow="false" Slash="0" ThreeD="false"><LEFTBORDER Type="Solid" Width="0.12mm"/><RIGHTBORDER Type="Solid" Width="0.12mm"/><TOPBORDER Type="None" Width="0.12mm"/><BOTTOMBORDER Type="Solid" Width="0.3mm"/><DIAGONAL Type="Solid" Width="0.12mm"/></BORDERFILL>
<BORDERFILL Id="35" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<RIGHTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<TOPBORDER Type="Solid" Width="0.12mm" Color="0"/>
<BOTTOMBORDER Type="Solid" Width="0.12mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.1mm" Color="0"/>
</BORDERFILL>
<BORDERFILL Id="36" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="None" Width="0.12mm" Color="0"/>
<RIGHTBORDER Type="None" Width="0.12mm" Color="0"/>
<TOPBORDER Type="None" Width="0.12mm" Color="0"/>
<BOTTOMBORDER Type="None" Width="0.12mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.1mm" Color="0"/>
</BORDERFILL>
<BORDERFILL Id="37" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="None" Width="0.1mm" Color="0"/>
<RIGHTBORDER Type="None" Width="0.1mm" Color="0"/>
<TOPBORDER Type="None" Width="0.1mm" Color="0"/>
<BOTTOMBORDER Type="None" Width="0.1mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.1mm" Color="0"/>
<FILLBRUSH><WINDOWBRUSH FaceColor="4294967295" HatchColor="0"/>
</FILLBRUSH>
</BORDERFILL>
</BORDERFILLLIST>
<CHARSHAPELIST Count="83">
<CHARSHAPE Id="0" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="2" Latin="2" Hanja="2" Japanese="2" Other="2" Symbol="2" User="2"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="1" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="2" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="1" Latin="1" Hanja="1" Japanese="1" Other="1" Symbol="1" User="1"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="3" Height="900" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="4" Height="900" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="1" Latin="1" Hanja="1" Japanese="1" Other="1" Symbol="1" User="1"/>
	<RATIO Hangul="95" Latin="95" Hanja="95" Japanese="95" Other="95" Symbol="95" User="95"/>
	<CHARSPACING Hangul="-5" Latin="-5" Hanja="-5" Japanese="-5" Other="-5" Symbol="-5" User="-5"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="5" Height="900" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="95" Latin="95" Hanja="95" Japanese="95" Other="95" Symbol="95" User="95"/>
	<CHARSPACING Hangul="-5" Latin="-5" Hanja="-5" Japanese="-5" Other="-5" Symbol="-5" User="-5"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="6" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{조문폰트}<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="7" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{법령명폰트}<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="8" Height="900" TextColor="16711680" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="2" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="9" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="10" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="-50" Latin="-50" Hanja="-50" Japanese="-50" Other="-50" Symbol="-50" User="-50"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="11" Height="1200" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{법령명폰트}<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="12" Height="1200" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="13" Height="1100" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="14" Height="1400" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="15" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="4" Japanese="4" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="16" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="17" Height="1700" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="18" Height="1600" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="4" Japanese="4" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="19" Height="1400" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="20" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="4" Japanese="4" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="21" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="6" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="22" Height="1300" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="23" Height="2000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="24" Height="1400" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="25" Height="1600" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="26" Height="3200" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="5" Latin="5" Hanja="5" Japanese="0" Other="5" Symbol="5" User="5"/>
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<BOLD/>
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<CHARSHAPE BorderFillId="0" Height="1200" Id="60" ShadeColor="4294967295" SymMark="0" TextColor="0" UseFontSpace="false" UseKerning="false">
	<FONTID Hangul="4" Hanja="4" Japanese="4" Latin="4" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Hanja="100" Japanese="100" Latin="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Hanja="100" Japanese="100" Latin="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE BorderFillId="0" Height="900" Id="61" ShadeColor="4294967295" SymMark="0" TextColor="0" UseFontSpace="false" UseKerning="false">
	<FONTID Hangul="3" Hanja="3" Japanese="3" Latin="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Hanja="97" Japanese="97" Latin="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Hanja="100" Japanese="100" Latin="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="62" Height="1000" TextColor="16711680" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="63" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="64" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="1" Latin="1" Hanja="1" Japanese="1" Other="1" Symbol="1" User="1"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="65" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="3" Latin="3" Hanja="0" Japanese="0" Other="3" Symbol="3" User="3"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="66" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="3" Latin="3" Hanja="0" Japanese="0" Other="3" Symbol="3" User="3"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="67" Height="2000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="4" Japanese="4" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="68" Height="1600" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="69" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="4" Japanese="2" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="70" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="6" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="71" Height="1300" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="72" Height="2000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="73" Height="3200" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="5" Latin="5" Hanja="5" Japanese="0" Other="5" Symbol="5" User="5"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="74" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="75" Height="1000" TextColor="16711680" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
<FONTID Hangul="2" Latin="2" Hanja="2" Japanese="2" Other="2" Symbol="2" User="2"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="76" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{법령명폰트}<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="77" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="78" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="79" Height="900" TextColor="16711680" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="2" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="80" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{조문폰트}<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="81" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE BorderFillId="0" Height="1000" Id="82" ShadeColor="4294967295" SymMark="0" TextColor="16711680" UseFontSpace="false" UseKerning="false">
	<FONTID Hangul="4" Hanja="0" Japanese="0" Latin="4" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Hanja="97" Japanese="97" Latin="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Hanja="100" Japanese="100" Latin="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
</CHARSHAPELIST>
<TABDEFLIST Count="4"><TABDEF Id="0" AutoTabLeft="false" AutoTabRight="false"/>
<TABDEF Id="1" AutoTabLeft="true" AutoTabRight="false"/>
<TABDEF Id="2" AutoTabLeft="false" AutoTabRight="true"/>
<TABDEF Id="3" AutoTabLeft="false" AutoTabRight="false"><TABITEM Pos="86662" Type="Right" Leader="Dot"/>
</TABDEF>
</TABDEFLIST>
<NUMBERINGLIST Count="1"><NUMBERING Id="1" Start="0"><PARAHEAD Level="1" Alignment="Left" UseInstWidth="true" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit">^1.</PARAHEAD>
<PARAHEAD Level="2" Alignment="Left" UseInstWidth="true" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="HangulSyllable">^2.</PARAHEAD>
<PARAHEAD Level="3" Alignment="Left" UseInstWidth="true" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit">^3)</PARAHEAD>
<PARAHEAD Level="4" Alignment="Left" UseInstWidth="true" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="HangulSyllable">^4)</PARAHEAD>
<PARAHEAD Level="5" Alignment="Left" UseInstWidth="false" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit"></PARAHEAD>
<PARAHEAD Level="6" Alignment="Left" UseInstWidth="false" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit"></PARAHEAD>
<PARAHEAD Level="7" Alignment="Left" UseInstWidth="false" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit"></PARAHEAD>
</NUMBERING>
</NUMBERINGLIST>
<PARASHAPELIST Count="82"><PARASHAPE Id="0" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="1" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="-2620" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="1" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="true"><PARAMARGIN Indent="0" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="2" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="3" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="3000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="4" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="2000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="5" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="1" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="4000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="6" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="2" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="6000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="7" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="3" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="8000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="8" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="4" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="10000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="9" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="5" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="12000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="10" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="6" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="14000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
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{법령집표지}
{인쇄저장표지}
{머리글}
{목차영역}
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Contrast="0" Effect="RealPic" BinItem="3"/></PICTURE><CHAR>&nbsp;법제처</CHAR></TEXT><TEXT CharShape="9"><CHAR></CHAR></TEXT></P></PARALIST></CELL><CELL ColAddr="1" RowAddr="0" ColSpan="1" RowSpan="1" Width="25701" Height="1982" Header="false" HasMargin="false" Protect="false" Editable="false" Dirty="false" BorderFill="3"><PARALIST TextDirection="0" LineWrap="Break" VertAlign="Center"><P ParaShape="17" Style="10"><TEXT CharShape="61"><CHAR>-&nbsp;</CHAR><AUTONUM Number="3" NumberType="Page"><AUTONUMFORMAT Type="Digit" Superscript="false"/></AUTONUM><CHAR>&nbsp;/&nbsp;</CHAR><AUTONUM Number="1" NumberType="TotalPage"><AUTONUMFORMAT Type="Digit" Superscript="false"/></AUTONUM><CHAR>&nbsp;-</CHAR></TEXT></P></PARALIST></CELL><CELL ColAddr="2" RowAddr="0" ColSpan="1" RowSpan="1" Width="12623" Height="1982" Header="false" HasMargin="false" Protect="false" Editable="false" Dirty="false" BorderFill="3"><PARALIST TextDirection="0" LineWrap="Break" VertAlign="Center"><P ParaShape="19" Style="10"><TEXT CharShape="9"><PICTURE><SHAPEOBJECT InstId="1310949373" ZOrder="3" NumberingType="Figure" Lock="false"><SIZE Width="1417" Height="1417" WidthRelTo="Absolute" HeightRelTo="Absolute" Protect="false"/><POSITION TreatAsChar="true" AffectLSpacing="false" VertAlign="Top" HorzAlign="Left" VertOffset="0" HorzOffset="0" FlowWithText="true"/><OUTSIDEMARGIN Left="0" Right="0" Top="0" Bottom="0"/></SHAPEOBJECT><SHAPECOMPONENT XPos="0" YPos="-887" GroupLevel="0" OriWidth="2760" OriHeight="2760" CurWidth="1416" CurHeight="1416" HorzFlip="false" VertFlip="false"><ROTATIONINFO Angle="0" CenterX="708" CenterY="708"/><RENDERINGINFO><TRANSMATRIX E1="1.00" E2="0.00" E3="0.00" E4="0.00" E5="1.00" E6="-887.00"/><SCAMATRIX E1="1.00" E2="0.00" E3="0.00" E4="0.00" E5="1.00" E6="0.00"/><ROTMATRIX E1="1.00" E2="0.00" E3="0.00" E4="0.00" E5="1.00" E6="3.12"/><SCAMATRIX E1="1.00" E2="0.00" E3="0.00" E4="0.00" E5="1.00" E6="0.00"/><ROTMATRIX E1="1.00" E2="0.00" E3="0.00" E4="0.00" E5="1.00" E6="3.12"/><SCAMATRIX E1="1.00" E2="0.00" E3="0.00" E4="0.00" E5="1.00" E6="0.00"/><ROTMATRIX E1="1.01" E2="0.00" E3="0.00" E4="0.00" E5="1.01" E6="-5.67"/><SCAMATRIX E1="0.51" E2="0.00" E3="0.00" E4="0.00" E5="0.51" E6="887.00"/><ROTMATRIX E1="1.00" E2="0.00" E3="0.00" E4="0.00" E5="1.00" E6="0.00"/></RENDERINGINFO></SHAPECOMPONENT><IMAGERECT X0="0" Y0="0" X1="2760" Y1="0" X2="2760" Y2="2760" X3="0" Y3="2760"/><IMAGECLIP Left="0" Top="0" Right="2700" Bottom="2700"/><INSIDEMARGIN Left="0" Right="0" Top="0" Bottom="0"/><IMAGE Bright="0" Contrast="0" Effect="RealPic" BinItem="2"/></PICTURE><CHAR>&nbsp;국가법령정보센터</CHAR></TEXT></P></PARALIST></CELL></ROW></TABLE><CHAR></CHAR></TEXT></P></PARALIST></FOOTER></TEXT><TEXT CharShape="62"><CHAR>[시행 2019. 11. 11] [총리령 제1570호, 2019. 11. 11, 일부개정]</CHAR></TEXT></P><P ParaShape="75"><TEXT CharShape="74"/></P><P ParaShape="76"><TEXT CharShape="74"><CHAR>식품의약품안전처(의약품품질과) 043-719-2781</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="6"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제1조(목적)</CHAR></TEXT><TEXT CharShape="6"><CHAR> 이 규칙은 「의약품 등의 제조업 및 수입자의 시설기준령」에서 위임된 사항과 그 시행에 필요한 사항을 규정함을 목적으로 한다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2013. 3. 23.&gt;</CHAR></TEXT>
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<P ParaShape="22"><TEXT CharShape="7"><CHAR>제2조(의약품 제조소의 시설 기준)</CHAR></TEXT><TEXT CharShape="6"><CHAR> ① 「의약품 등의 제조업 및 수입자의 시설기준령」(이하 "영"이라 한다) 제3조제1항제1호에 따른 작업소(이하 "작업소"라 한다)는 다음 각 호의 기준에 따라야 한다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2009. 7. 1., 2010. 9. 20., 2013. 3. 23., 2015. 12. 31., 2016. 10. 28.&gt;</CHAR></TEXT>
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<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 무균제제(無菌製劑)(주사제ㆍ점안제 및 안연고제를 말한다. 이하 같다)의 작업소, 페니실린제제의 작업소, 세팔로스포린제제의 작업소, 카바페넴제제의 작업소, 모노박탐제제의 작업소, 성호르몬제제의 작업소, 세포독성 항암제제의 작업소, 생물학적제제등(「의약품 등의 안전에 관한 규칙」 제4조제1항제1호에 따른 생물학적제제등을 말한다. 이하 같다)의 작업소 및 그 밖의 제제 작업소는 각각 분리되어 있을 것. 다만, 다음 각 목의 어느 하나에 해당하는 경우에는 그러하지 아니할 수 있다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 사(死)백신(교차 오염 위험성이 있는 포자형성균 등을 이용하는 경우는 제외한다)을 제조하는 경우로서 밸리데이션 등을 통하여 충분한 오염방지 대책이 마련되고, 교차 오염될 우려가 없으며, 균주ㆍ세포주ㆍ조직 등을 무독화하거나 불활화 처리한 경우</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 유전자재조합의약품 또는 유전자조작기술을 이용한 백신을 제조하는 경우로서 밸리데이션 등을 통하여 충분한 오염방지 대책이 마련되고, 교차 오염될 우려가 없으며, 정제(精製)공정을 완료한 경우</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 주사제의 작업소, 점안제의 작업소, 내용고형제의 작업소, 내용액제의 작업소, 외용액제의 작업소, 연고제의 작업소 및 그 밖에 제조공정이 서로 다른 제형(劑形)의 작업소는 각각 구획되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ② 제1항제1호 및 제2호에도 불구하고 폐쇄식 기계설비 등에 의하여 교차 오염될 우려가 없는 작업소는 분리하거나 구획하지 아니할 수 있다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ③ 작업소에는 다음 각 호의 시설을 두어야 한다. 다만, 식품의약품안전처장이 해당 의약품의 제조방법이 원료 합성 등과 같이 특수하다고 인정하는 경우에는 안전을 확보할 수 있는 적절한 조치를 취하고 그 시설의 일부를 작업소 외에 둘 수 있다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2013. 3. 23.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 해당 제조소에서 제조하는 의약품의 제조 등에 필요한 용수시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 쥐ㆍ해충ㆍ먼지 등을 막을 수 있는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 위생적인 화장실ㆍ탈의실 및 수세시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  4. 소독시설(무균제제ㆍ내용액제ㆍ연고제의 작업소의 경우에만 해당한다)</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ④ 작업소에는 제조하는 의약품의 종류ㆍ제형ㆍ제조방법 및 제조시설에 따라 필요한 작업실을 두어야 한다. 다만, 의약품의 품질에 영향을 미치지 아니하는 범위에서 원료의 칭량(稱量)작업실, 제품의 포장작업실 또는 용기의 세척작업실은 각 작업소별로 두지 아니할 수 있으며, 식품의약품안전처장이 해당 의약품의 제조방법이 원료 합성 등과 같이 특수하다고 인정하는 경우에는 작업실을 두지 아니할 수 있다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2013. 3. 23.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ⑤ 제4항에 따른 작업실에는 다음 각 호의 시설을 설치하여야 한다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 작업대</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 가루가 날리는 작업실에는 가루를 제거하는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 흡습성제제를 취급하는 경우에는 습도 조절시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  4. 건조설비가 있는 경우에 그 건조설비의 가열장치는 자동온도 조절이 가능한 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ⑥ 영 제3조제1항제2호에 따른 시험실(이하 "시험실"이라 한다)은 다음 각 호의 구분에 따라야 한다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 미생물시험을 하는 경우：일반시험실과 구획된 무균시험실[무균시험실에는 무균실이나 무균적 조건을 갖춘 무균시설이 있어야 하고, 무균실의 경우 외부와 직접 통하지 아니하도록 전실(前室)을 두어야 함]이 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 동물시험을 하는 경우：일반시험실과 분리되어 위생적인 상태를 유지할 수 있는 동물시험실(동물시험실에는 시험동물의 사육 및 동물시험에 필요한 시설과 기구가 있어야 함)이 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ⑦ 영 제3조제1항제3호에 따른 보관소(이하 "보관소"라 한다)는 위생적이어야 하며, 품질에 영향을 미치지 아니하도록 원료ㆍ자재 및 제품별로 각각 구획되어야 한다. 다만, 보관소가 원료ㆍ자재 및 제품별로 뒤섞일 우려가 없도록 설비된 경우에는 구획하지 아니할 수 있다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제3조(완제의약품 작업소의 시설 기준)</CHAR></TEXT><TEXT CharShape="6"><CHAR> 인체에 직접 적용하는 완제의약품(의료용 고압가스 및 방사성의약품은 제외한다. 이하 같다) 작업소의 시설은 제2조에 따른 기준 외에 다음 각 호의 기준에 따라야 한다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 작업소의 출입구와 창은 완전히 밀폐될 수 있어야 하며, 작업소에는 다음 각 목의 시설을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 제조하는 의약품의 종류ㆍ제형 또는 제조방법에 따라 오염을 방지하고 적절한 온도를 유지하며 필요한 경우에는 습도를 유지할 수 있는 공기조화장치</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 제조공정관리에 필요한 시험검사시설 또는 시험검사기구</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 제조과정 중의 반제품을 품질에 영향을 미치지 아니하도록 보관할 수 있는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 원료의 칭량작업, 의약품의 조제ㆍ충전작업 및 의약품의 마개를 막는 작업이나 밀봉작업을 하는 작업실은 다음 각 목의 기준에 따를 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 천장은 먼지가 떨어질 우려가 없도록 마무리되고, 바닥과 벽은 표면이 매끄럽고 먼지나 오물을 쉽게 제거할 수 있도록 되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 실내의 배관은 청소하기 쉽고 배관이 벽을 통과할 경우 틈이 없도록 마무리되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 출입구(비상구는 제외한다)와 창은 외부와 직접 통하지 아니하도록 되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    라. 작업실은 작업원 외의 자의 통로가 되지 아니하도록 되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제4조(무균제제 작업소의 시설 기준)</CHAR></TEXT><TEXT CharShape="6"><CHAR> 무균제제 작업소의 시설은 제2조와 제3조에 따른 기준 외에 다음 각 호의 기준에 따라야 한다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 작업소에는 다음 각 목의 시설을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 용기의 세척시설, 세척 후 건조ㆍ멸균에 필요한 시설 및 멸균상태를 유지할 수 있는 보관시설(해당 시설이 있는 작업실은 제3조제2호 각 목에 적합하여야 한다)</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 무균제제의 종류에 따른 멸균시설 또는 제균시설(가열멸균시설인 경우 멸균작업 중 그 시설안의 어떠한 부분에서도 필요한 멸균조건을 유지할 수 있는 시설이어야 한다)</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 이물(異物)검사에 필요한 시설 및 기구</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    라. 밀봉검사에 필요한 시설 및 기구(밀봉상태의 검사를 하는 경우에만 해당한다)</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 원료의 칭량작업, 의약품의 조제ㆍ충전작업 및 밀봉작업을 하는 작업실과 복도 등 무균작업에 필요한 관리구역은 다음 각 목의 기준에 따를 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 제균된 공기를 공급하는 시설을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 천장ㆍ바닥 및 벽의 표면은 소독액을 뿌려 세척하는 것에 견딜 수 있도록 되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 작업실 안으로 원료ㆍ자재 등을 반입하기 위한 작업준비실을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    라. 작업원의 출입을 위하여 무균작업에 필요한 관리구역과 연결된 작업원 전용(專用) 탈의실 및 소독시설을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 무균적 조작이 필요한 무균원료의 칭량 및 조제작업실과 무균제제의 충전 및 밀봉작업실은 제2호 각 목의 기준에 따라야 하고, 아울러 무균실이나 무균적 조건을 갖춘 무균시설을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제5조(페니실린제제, 세팔로스포린제제, 카바페넴제제, 모노박탐제제, 성호르몬제제 또는 세포독성 항암제제 작업소의 시설기준)</CHAR></TEXT><TEXT CharShape="6"><CHAR> ① 페니실린제제, 세팔로스포린제제, 카바페넴제제, 모노박탐제제, 성호르몬제제 또는 세포독성 항암제제 작업소의 시설은 제2조와 제3조에 따른 기준 외에 다음 각 호의 기준에 따라야 한다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2010. 9. 20., 2016. 10. 28.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 작업소와 연결된 작업원 전용 탈의실 및 수세시설을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 작업실 안으로 원료ㆍ자재 등을 반입하기 위한 작업준비실을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 다른 의약품 작업소와 별도로 된 공기조화장치를 설치하고, 페니실린제제 작업소용 공기조화장치는 방출 공기의 종말처리시설을 갖출 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ② 페니실린제제, 세팔로스포린제제, 카바페넴제제, 모노박탐제제, 성호르몬제제 또는 세포독성 항암제제의 무균제제를 제조하는 경우에는 제1항제1호부터 제3호까지의 기준 외에 제4조의 시설 기준에 따라야 한다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2010. 9. 20., 2016. 10. 28.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="68" Style="0"><TEXT CharShape="8"><CHAR>  [제목개정 2016. 10. 28.]</CHAR></TEXT></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제6조(생물학적제제등 작업소의 시설 기준)</CHAR></TEXT><TEXT CharShape="6"><CHAR> 생물학적제제등 작업소의 시설은 제2조와 제3조의 기준 외에 다음 각 호의 기준에 따라야 한다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2013. 3. 23., 2015. 2. 17., 2015. 12. 31.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 작업소에는 다음 각 목의 시설을 설치할 것(생물학적제제등의 종류 및 제조방법에 따라 해당 제제를 제조하는 데에 필요하지 아니한 시설은 갖추지 아니할 수 있다)</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 세포나 미생물의 저장시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 제조 또는 시험에 사용하는 동물 중 미생물을 접종한 동물을 관리하는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 제조 또는 시험에 사용하는 동물을 처리하는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    라. 미생물을 배지(培地)에 이식하는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    마. 세포나 미생물의 배양시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    바. 배양한 세포나 미생물의 회수(回收)ㆍ정제ㆍ불활화(不活化：본래 가지고 있는 기능을 없애는 작용)ㆍ살균 등을 하는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    사. 원액의 희석용액을 조제하는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    아. 원액의 희석시설ㆍ분주(分注)시설과 용기의 밀봉시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    자. 제조 또는 시험에 사용한 기구ㆍ기계 등의 소독시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    차. 「혈액관리법 시행규칙」 별표 4에 따른 시설(장비를 포함한다)</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 제1호에 따른 시설이 있는 작업실은 천장ㆍ바닥 및 벽의 표면이 세척과 소독에 견딜 수 있고, 제품, 공정 및 기계ㆍ설비 등을 고려하여 적절히 분리되거나 구획되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 제1호가목ㆍ나목ㆍ라목ㆍ마목ㆍ자목 또는 차목의 시설 중 다음 각 목의 병원체 등을 취급하는 시설 또는 그 시설이 있는 작업실은 해당 병원체 등의 종류별로 분리 또는 구획되어 전용할 수 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 비씨지 백신에 사용되는 결핵균</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 투베르쿨린(tuberculin) 제제 생산에 사용되는 결핵균</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 불활화 공정이 완료되기 전의 포자형성균</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    라. 폴리오병원체</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    마. 사람의 혈액 또는 혈장</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    바. 그 밖에 병원성 미생물, 살아있는 미생물ㆍ세포 등 가목부터 마목까지에 준하는 관리가 필요하다고 식품의약품안전처장이 인정하는 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  4. 제1호라목부터 아목까지 및 차목에 따른 시설이 있는 무균작업에 필요한 관리구역은 제4조제2호 및 제3호의 기준에 따를 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  5. 작업소에는 제1호 각 목에 따른 시설 외에 다음 각 목의 시설을 두되, 다음 각 목의 시설이 있는 작업실은 제3조제2호의 기준에 따를 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 제조에 사용하는 동물을 식품의약품안전처장이 정하는 기간 이상 사육 및 관리할 수 있는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 시험에 사용하는 동물의 사육 및 관리에 필요한 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 배지 및 희석용액의 조제시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    라. 제조 또는 시험에 사용하는 기구ㆍ용기 등의 세척 및 멸균시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  6. 보관시설에는 항온장치, 자동온도기록계 및 그 밖에 필요한 계량기계를 갖추어 둘 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="68" Style="0"><TEXT CharShape="8"><CHAR>  [제목개정 2015. 12. 31.]</CHAR></TEXT></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제7조(원료의약품 작업소의 시설 기준)</CHAR></TEXT><TEXT CharShape="6"><CHAR> 원료의약품 작업소(한약재제조소의 작업소는 제외한다. 이하 같다)는 제2조에 따른 기준 외에 작업소의 종류에 따라 다음 각 호의 기준에 따라야 한다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2010. 9. 20., 2015. 12. 31., 2016. 10. 28.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 원료의약품 작업소 중 여과ㆍ분쇄ㆍ정제 및 충전 작업을 하는 작업실은 제3조 각 호의 기준</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 무균제제의 원료의약품 작업소의 시설은 제4조 각 호(같은 조 제1호다목 및 라목은 제외한다)의 기준</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 페니실린제제의 원료의약품 작업소, 세팔로스포린제제의 원료의약품 작업소, 카바페넴제제의 원료의약품 작업소, 모노박탐제제의 원료의약품 작업소, 성호르몬제제의 원료의약품 작업소 또는 세포독성 항암제제의 원료의약품 작업소의 시설은 제5조제1항 각 호의 기준. 이 경우 해당 작업소의 시설은 다른 작업소의 시설과 분리되어 있어야 한다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  4. 생물학적제제등의 원료의약품 작업소의 시설은 제6조 각 호의 기준</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제8조(의약외품 제조소의 시설 기준)</CHAR></TEXT><TEXT CharShape="6"><CHAR> ① 「약사법」(이하 "법"이라 한다) 제2조제7호가목의 물품을 제조하는 의약외품 제조소의 작업소 시설은 다음 각 호의 기준을 따라야 한다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 작업소는 다음 각 목의 기준을 따를 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 쥐ㆍ해충ㆍ먼지 등을 막을 수 있는 시설을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 멸균이 필요한 제품을 제조하는 작업소의 천장은 먼지가 떨어질 우려가 없도록 마무리되고, 바닥과 벽은 매끄럽고 먼지나 오물을 쉽게 제거할 수 있도록 되어 있으며, 천장ㆍ바닥ㆍ벽의 표면은 소독액을 뿌려 세척하는 것에 견딜 수 있도록 되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 작업소에는 다음 각 목의 시설을 설치할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 작업대</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 멸균이 필요한 제품을 제조하는 경우에는 적합한 멸균시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 보관소는 원료ㆍ자재 및 제품을 위생적이고 안전하게 보관할 수 있도록 설비되어 있을 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ② 법 제2조제7호나목 및 다목의 물품을 제조하는 의약외품 제조소의 시설 기준에 관하여는 제2조를 준용하되, 「의약품 등의 안전에 관한 규칙」 제48조제6호 전단에 따른 적합 판정의 대상이 되는 의약외품 제조소의 시설 기준에 관하여는 제2조 및 제3조를 각각 준용한다. 이 경우 "의약품"은 "의약외품"으로 본다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2010. 9. 20., 2015. 12. 31.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ③ 법 제2조제7호나목 및 다목의 물품 중 파리나 모기 등의 구제제, 방지제, 기피제, 유인살충제 및 감염병 예방용 살충제ㆍ살서제(이하 "구제제등"이라 한다)를 제조하는 작업소(유효성분 칭량, 조제ㆍ충전 및 밀폐ㆍ밀봉 작업을 하는 작업실만 해당한다)는 구제제등 외의 의약외품 작업소와 분리되어 있어야 한다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;신설 2015. 12. 31.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제9조(의약품 등의 수입자의 시설 기준)</CHAR></TEXT><TEXT CharShape="6"><CHAR> ① 영 제6조제1항제1호에 따른 창고에는 다음 각 호의 시설을 두어야 한다. 다만, 제2호부터 제5호까지의 시설은 해당 의약품 또는 의약외품(이하 "의약품등"이라 한다)을 취급하는 경우에만 해당한다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 쥐ㆍ해충 등을 막을 수 있는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 저온 보관 및 빛가림을 위한 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 생물학적 제제의 보관시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  4. 마약 및 향정신성의약품의 보관시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  5. 보관방법이 정하여진 의약품등의 경우에는 그 보관조건을 유지할 수 있는 시설</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ② 의약품등을 수입하는 자가 영 제6조제1항제2호 단서에 따라 제11조에 따른 시험의 수탁자의 시설 및 기구를 이용하여 시험검사를 하는 경우에는 시험실을 따로 두지 아니할 수 있다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제10조</CHAR></TEXT><TEXT CharShape="6"><CHAR> 삭제 </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;2013. 3. 23.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제11조(수탁자의 범위와 준수사항 등)</CHAR></TEXT><TEXT CharShape="6"><CHAR> ① 영 제4조제1항에 따라 의약품등의 제조업자가 의약품등의 제조 또는 시험을 다른 의약품등의 제조업자 등에게 위탁하는 경우 그 수탁자의 범위는 다음 각 호와 같다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2010. 9. 20., 2013. 3. 23., 2014. 8. 20., 2015. 2. 17., 2019. 11. 11.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 제조의 수탁자. 다만, 나목 및 다목의 수탁자는 의약외품의 제조 또는 시험을 위탁하는 경우에만 해당한다.</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 의약품등의 제조업자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 의약품등 외의 물품 제조업자로서 자동에어로졸 충전, 연필 제조, 가스 주입, 도금, 주물, 단조, 판금, 사출, 인쇄, 코팅, 도장, 멸균, 직조, 타면, 덴타 또는 설계에 관한 공정을 수행하는 자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 의약품등 외의 물품 제조업자로서 부분품 또는 부품의 제조를 전문으로 하는 자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    라. 의약품등 외의 물품 제조업자로서 원료의약품의 합성공정 중 수소화반응 공정을 수행하는 자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    마. 세포독성 항암제제 등 식품의약품안전처장이 고시하는 의약품의 생산시설을 갖춘 자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 시험의 수탁자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    가. 특별시ㆍ광역시ㆍ도 및 특별자치도의 보건환경연구원</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    나. 법 제67조에 따라 조직된 사단법인인 한국의약품수출입협회</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    다. 의약품등의 제조업자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    라. 「식품ㆍ의약품분야 시험ㆍ검사 등에 관한 법률」 제6조제2항제3호에 따른 의약품 등 시험ㆍ검사기관</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    마. 「먹는물관리법」 제43조제2항에 따른 먹는물 수질검사기관[「약사법」 제51조에 따른 대한민국약전에 실린 상수(上水)의 시험만 해당한다]</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="79"><TEXT CharShape="6"><CHAR>    바. 「혈액관리법」 제2조제3호에 따른 혈액원(같은 법 제2조제8호에 따른 혈액제제의 시험만 해당한다)</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ② 제1항에도 불구하고, 「마약류 관리에 관한 법률」 제2조제5호나목 또는 다목에 따른 마약류제조업자 또는 마약류원료사용자가 마약, 향정신성의약품 및 이를 원료로 하는 의약품의 제조를 위탁하는 경우 그 수탁자의 범위는 다음 각 호의 구분에 따른다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;신설 2011. 7. 7., 2012. 6. 15., 2015. 2. 17.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 마약: 「마약류 관리에 관한 법률」 제21조에 따라 마약 제조품목허가를 받은 마약류제조업자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 향정신성의약품: 「마약류 관리에 관한 법률」 제21조에 따라 향정신성의약품 제조품목허가를 받은 마약류제조업자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 마약 및 향정신성의약품을 원료로 하는 의약품: 「마약류 관리에 관한 법률」 제2조제5호다목에 따른 마약류원료사용자</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ③ 영 제4조제1항에 따라 의약품등의 제조업자가 의약품등의 제조 또는 시험을 다른 의약품등의 제조업자 등에게 위탁하는 경우 위탁자 및 수탁자의 준수사항은 다음 각 호와 같다. </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;개정 2011. 7. 7.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  1. 의약품등 제조 또는 시험의 위탁자는 제조 또는 시험이 적절하게 이루어지도록 수탁자에 대한 관리ㆍ감독을 철저히 하고, 수탁자로부터 제조 및 품질관리의 기록에 관한 서류를 받아 3년 이상 보존할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  2. 의약품등 제조의 위탁자는 제품표준서를 작성하여 수탁자에게 제공하고, 수탁자는 이를 기준으로 제품마다 제조관리기준서 및 품질관리기준서를 작성하여 그 기준서에 따른 기록에 관한 서류를 위탁자에게 제출하고 수탁 제조 시 사용한 첨가제 및 용기 등에 대한 품질관리를 철저히 할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  3. 의약품등 시험의 위탁자는 위탁시험에 따른 기준 및 시험방법과 시험용 검체(檢體)를 수탁자에게 제공하며, 수탁자는 각 검체에 대한 시험기록에 관한 서류를 위탁자에게 제출하고 수탁시험에 필요한 시약 및 표준품 등의 관리를 철저히 할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="78"><TEXT CharShape="6"><CHAR>  4. 의약품등의 제조 또는 시험의 수탁자는 제조 공정에 따른 제조 또는 시험에 필요한 시설 및 기구를 갖추고, 그 최종 제품의 품질관리를 철저히 할 것</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="77"><TEXT CharShape="6"><CHAR>  ④ 삭제 </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;2013. 3. 23.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="22"><TEXT CharShape="7"><CHAR>제12조</CHAR></TEXT><TEXT CharShape="6"><CHAR> 삭제 </CHAR></TEXT><TEXT CharShape="8"><CHAR>&lt;2013. 3. 23.&gt;</CHAR></TEXT>
<TEXT CharShape="8"/></P>
<P ParaShape="2"><TEXT CharShape="6"/></P>
<P ParaShape="2"><TEXT CharShape="7"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="8"><CHAR>&nbsp;&lt;제1570호, 2019. 11. 11.&gt; &nbsp;</CHAR></TEXT> </P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  이 규칙은 공포한 날부터 시행한다.</CHAR></TEXT><TEXT CharShape="6"/></P>

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{국가법령이미지로고}
{이미지파일}
<BINDATA Size="252903" Encoding="Base64" Id="4">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</BINDATA>
</BINDATASTORAGE>
</TAIL>
</HWPML>
