This article gives a general overview of the document retention periods as indicated by the Code of Federal Regulations Title 21, Article 9 of the EC Directive and the WHO guide of Finished Products.
Records and Reports : Subpart J
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 one year after the expiration date of the batch or, in the case of certain OTC drug roducts lacking expiration dating because they meet the criteria for exemption under §211.137, three years after distribution of the batch.
Article 9 of EC Directive 91/356/EEC
The manufacturer shall have a system of documentation based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations that they perform. …Pre-established procedures for general manufacturing operations and conditions shall be available, together with specific documents for the manufacture of each batch. This set of documents shall make it possible to trace the history of the manufacture of each batch. “The batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification … (by the Qualified Person), and release whichever is the longer”.
There is some ambiguity here. For example, it is not clear what precisely is meant by “this set of documents” and “the batch documentation,” or whether or not these two expressions mean (more or less) the same thing. Thus, it is difficult to be sure if the stated retention period applies to batch manufacturing and packaging records only, or to documents relating to control, distribution components, drug product containers, and labeling as well (as in US 211.180 (a) and (b)).
However, a specific requirement relating to the retention period for “Quality Control documentation” does appear in EC GMP Guide, thus:
Chapter 6 Quality Control
Any Quality Control documentation relating to a batch record should be retained for one year after the expiry date of the batch and at least 5 years after the certification (of the batch, by the Qualified Person).
Two further clauses in the EC GMP Guide also make it clear that distribution records are to be retained, but they do not specifically state a retention period.
Chapter 4 Documentation
Records should be maintained of the distribution of each batch of a product in order to facilitate the recall of the batch if necessary.
WHO guidance of Finished products
Records should be made or completed when any action is taken and in such a way that all significant activities concerning the manufacture of pharmaceutical products are traceable. Records should be retained for at least one year after the expiry date of the finished product.
A Specific Guidance For API’s by ICHQ7A Documents
Suggested retention periods include:
- general production, analytical, control and distribution records 7 years *
- clinical batches for an IND or NDA LC + 1 year
- batches for bioequivalence testing LC + 1 year
- product development reports LC + 1 year
- development and validation reports of analytical test procedures LC + 1 year
- process validation reports LC + 1 year
- equipment IQ, OQ and PQ reports LC + 1 year
- supporting systems (e.g. utilities, computerised systems) LC + 1 year
- Training records 7 years (for clinical trials and demonstration batches LC + 1 year should be considered)
Note: LC means “life cycle” of the product where shelf life is included. “Life cycle” means the process starting with the user requirements, continues through design, realization, qualification, process validation and maintenance until the stadium of not in use.
* after the date of the record ( especially production records)