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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Testing records and laboratory document retention procedures ore required
because it is a GMP and legal requirement to retain critical documents for
prescribed periods. there are many instances where access to historical
documents and records beyond the minimum GMP requirement are needed, for
example, with product safety investigations, pharmacovigilance reviews,
complaint investigation, and legal enquiries. Any SOP or policy should reflect
these business needs as well.
What do the GMP rules say?
US FDA CFR 211
Sec. 211.180 General requirements.
(a) Any production, control, or distribution record that is required to be
maintained in compliance with this part and is specifically associated with a
batch of a drug product shall be retained for at least 1 year after the expiration
date of the batch or, in the case of certain OTC drug products lacking expiration
dating because they meet the criteria for exemption under 211.137, 3 years after
distribution of the batch.
International GMPs
Chapter 4 Documentation
4.8 The records should be made or completed at the time each action is taken
and in such a way that all significant activities concerning the manufacture of
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