![]() So is a Quality Manual needed to comply with GMP? Well the answer is YES. Is a Quality Manual required to comply with GMP?Ĭhapter 4 of European Union Good Manufacturing Practice (EU GMP) covers the documents and records required by a pharmaceutical manufacturing site, yet unfortunately it makes no mention of a Quality Manual or what its contents should be. By looking at the contents of a Quality Manual then an auditor will start to get an appreciation of an organisation in advance of an audit. It is common for a good auditor to ask to see a Quality Manual in advance of an audit to get a feel for the organisation’s QMS. ![]() ![]() It can be used both internally (for employees) and externally (for customers and auditors). A Quality Manual is a top-level document that describes an organisation’s Quality Management System (QMS). A Quality Manual is a document that was first required by the ISO 9001 standard for Quality Management Systems.
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