Document Retention: Regulatory Guidance

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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.

They are:

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)

选自：http://learnaboutgmp.com/document-retention-regulatory-guidance/

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4.11 Specific requirements apply to batch documentation which must be kept for one year after expiry of the batch to which it relates or at least five years after certification of the batch by the Qualified Person, whichever is the longer. For investigational medicinal products, the batch documentation must be kept for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used. Other requirements for retention of documentation may be described in legislation in relation to specific types of product (e.g. Advanced Therapy Medicinal Products) and specify that longer retention periods be applied to certain documents.

4.12 For other types of documentation, the retention period will depend on the business activity which the documentation supports. Critical documentation, including raw data (for example relating to validation or stability), which supports information in the Marketing Authorisation should be retained whilst the authorization remains in force. It may be considered acceptable to retire certain documentation (e.g. raw data supporting validation reports or stability reports) where the data has been superseded by a full set of new data. Justification for this should be documented and should take into account the requirements for retention of batch documentation; for example, in the case of process validation data, the accompanying raw data should be retained for a period at least as long as the records for all batches whose release has been supported on the basis of that validation exercise.

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