WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles - Documentation
15. Documentation:
15.1 Principle. Good documentation is an essential part of the quality assurance system and, as such, should exist for all aspects of GMP. Its aims are to define the specifications and procedures for all materials and methods of manufacture and control; to ensure that all personnel concerned with manufacture know what to do and when to do it; to ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a medicine for sale; to ensure the existence of documented evidence, traceability, and to provide records and an audit trail that will permit investigation. It ensures the availability of the data needed for validation, review and statistical analysis. The design and use of documents depend upon the manufacturer. In some cases some or all of the documents described below may be brought together, but they will usually be separate.
General:
15.2 Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing and marketing authorizations.
15.3 Documents should be approved, signed and dated by the appropriate responsible persons. No document should be changed without authorization and approval.
15.4 Documents should have unambiguous contents: the title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.
15.5 Documents should be regularly reviewed and kept up to date. When a document has been revised, a system should exist to prevent inadvertent use of the superseded version. Superseded documents should be retained for a specific period of time.
15.6 Where documents require the entry of data, these entries should be clear, legible and indelible. Sufficient space should be provided for such entries.
15.7 Any alteration made to a document should be signed and dated; the alteration should be done in such a way as to permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.
15.8 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.
15.9 Data (and records for storage) may be recorded by electronic dataprocessing systems or by photographic or other reliable means. Master formulae and detailed SOPs relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data-processing methods, only authorized persons should be able to enter or modify data in the computer system, and there should be a record of changes and deletions; access should be restricted by passwords or other means and the entry of critical data should be independently checked. Batch records stored electronically should be protected by back-up transfer on magnetic tape, microfilm, electronic discs, paper printouts or other means. It is particularly important that, during the period of retention, the data are readily available.
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles
(Annex 2, WHO Technical Report Series 986, 2014)
