Pp. 199-234 (36)
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 This is why they have to be kept updated and superseded documents have to be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.
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.
Glez. Tablas 17, Barcelona, Spain.