Professional Documents
Culture Documents
GMP Aspects Ka Assessment
GMP Aspects Ka Assessment
Wondiyfraw Worku
Assessor
May 2014
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Outline
Assessor-inspector communication
Possible scenarios
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Regulatory strategy-
Risk reduction
One does not make sense
without the others!
Dossier One assumes that the
review Inspection of
mfg, testing others are being met
Product and clinical • assumptions are verified
sites through the life cycle of
the product
Post approval
regulatory
activities There may be overlaps in
certain aspects e.g.
- Readiness for
review/inspection of
Variations, compliant commercial mfg
- Conformity to
process validation data
handling, quality dossier info
surveillance, - Dossier data
Vigilance, safety update integrity audit
3 etc..
GMP documentation in dossiers- provide
minimum basis for review
Manufacturing license
issued by national competent authority
usually certifies that a given site has been
authorized to perform the claimed duties
may or may not specify specific products but at
least the authorized dosage form/line
important to establish the basic legal and
regulatory status of the manufacturer
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GMP documentation- Contd
GMP certificate
Certifies that a given site has been inspected by the
national inspector (in accordance with local
requirements) and deemed to be of acceptable
compliance.
• Local requirement may make reference to WHO
GMP requirements but does not mean that the
site has been inspected by WHO
In some jurisdictions, GMP certification is part of
the manufacturing license
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GMP documentation- Contd
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Certificate of Pharmaceutical Product-contd
Primarily intended to promote faster approval and speedy
access to medicines by helping recipient countries to depend
on sending authorities marketing authorization
Being also used in various other ways
• As a key criteria for registration even though the
application is supported by full dossier data
• As supporting document for tenders
• As a substitute for mfg license and GMP certificates
WHO’s blue book provides recommendations on appropriate
use of CPP in various scenarios
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WHO Blue Book recommendation
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Implementation in PQ
Full dossier route SRA route
If available, CPP, should be submitted CPP as issued by the reference SRA
- As a minimum, manufacturing license for should be submitted
the specific sites involved in manufacturing
activities should be submitted
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Documents that must be signed by QA, dated
and/or version tracked
Cover and undertaking letter
Specifications
Commitments
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Assessor-inspector communication
Via common databases
Easy traceability of all sites related to a given application
Specific recommendations/feedbacks
Recommendation for inspection of raw data
The need for re-review of bioequivalence data
At the time of PQ
PQ decision form to be signed in by assessment and inspection heads
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Examples of possible recommendations from
assessors
Instances of unsolicited major changes in QA signed
documentations (e.g. Specs, batch records)
Questions document approval procedure within the company
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Examples- contd
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Example-contd
Inconsistent responses
e.g.- “ we have data” but then fails to provide the data
or they may state “ we do not have data” but then after a while “ we
had the data”
“We did that” and after a while “ it was a typo”
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Example-contd
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Example-contd
Very similar batch to batch results, as in the case of
dissolution profiles
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Thank you, Questions?
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