Ich Q7a And Its Use During Inspections Without Notes
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ICH Q7A GMP Guidance for APIs and its Use During Inspections
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) ) 1 + + + & 8# + 3 + 1 ) M
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ttp://www.ifpma.org/ic 1. tml
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+ '(,
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ÿ
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c '( & & + 4 & 1
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Basic C emicals
-
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Drug Product P ysical Processing (granulating, dissolving, mixing, compressing)
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In t is guide t e term ³s ould´ indicates recommendations t at are expected to apply unless s own to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. -
$$ c / 0 ÔDA Version In t is guide t e term s ould identifies recommendations t at, w en followed, will ensure compliance wit CGMPs. An alternative approac may be used if suc approac satisfies t e requirements of t e applicable statutes. M
> $ +'(
Increasing GMP Expectations
!
+'(
C emical Manufacturing Outside scope
Covered by Q7A
Production of
Introduction of
API itarting
API itarting
Material
Material
of Intermediates
P ysical
Isolation
Production
&
Purification
Processing & Packaging ë
+'( Classical Ôermentation/ Outside scope
Establis ment /Maintenance of ·orking Cell Banks
Covered by Q7A
Introduction of Cells into Ôermentation
P ysical
Isolation
& Purification
Processing & Packaging
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+
)-+
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&
+
Ñ
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'( + G
a
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)
20 p !"#$$# % & '
-
, Controls increase as process proceeds to final isolation and purification steps
Apply GMP controls beginning wit t e use of API starting materials
Degree of control depends on process and manufacturing stage M
A * ' + Drug Products
APIs
)
)
*
+
) Ñ!
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