Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook


Author(s): Jordi Botet

Pp: 199-234 (36)

DOI: 10.2174/9781681081144115010008

* (Excluding Mailing and Handling)


Documentation is an essential GMP feature. If the PQS is something like a nervous system, then the documents are the nerves which carry information and which keep an organism alive and operational. This information has to be exact, clear and delivered safely where it is necessary. This is why the lifecycle of documents is critical. It is indispensable ensuring that they are well written and reviewed and approved by the right persons. Personnel using these documents have to receive copies and get well acquainted with them. This is vital, but not easy to ensure. Documents should reflect reality. This is why they have to be kept updated and superseded documents have to be returned to QA. Documents are crucial because they define how operations have to be performed, but also because they allow for traceability in the operations. The documents of a PQS are so numerous that document management requires hard work. Consequently there is always the risk of considering it something unworthy and boring, to be allotted to unlucky novice technicians. As a matter of fact documents reflect so trustworthy reality that is almost impossible doing wrong and showing good documentation or doing right and providing poor documentation, and this is why inspectors pay particular attention to documentation. Disorganized documentation is the hallmark of a disorganized company. Although documentation is usually associated to paper, this is not exact. Documentation is information on any support, ensuring traceability, safety and readability at any time. Tentative lists of the documents which are required in a manufacturing laboratory are given in this chapter.

Keywords: Accessibility, approval, BMR, code, controlled copy, data back-up, drawing, instruction, label, log (log-book), master document, master formula, master record, procedure, record, retention time, review, SOP, specification, version.

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