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What is a Quality Manual?

A Quality Manual is a document that was first required by the ISO 9001 standard for Quality Management Systems.  A Quality Manual is a top-level document that describes an organisation’s Quality Management System (QMS).  It can be used both internally (for employees) and externally (for customers and auditors).  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.  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.

Is a Quality Manual required to comply with GMP?

Chapter 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.  So is a Quality Manual needed to comply with GMP?  Well the answer is YES.  In Chapter 1 of EU GMP, covering the Pharmaceutical Quality System, it states “the Pharmaceutical Quality System should be defined and documented.  A Quality Manual or equivalent documentation should be established and should contain a description of the Quality Management System including management responsibilities” (clause 1.7).   So it is a requirement to have a Quality Manual, but we get little guidance of what it should contain, other than “a description of the Quality Management System including management responsibilities”.

Quality Manual Contents

Chapter 4 of EU GMP (Documentation) should give more detail of the contents of a Quality Manual, yet unfortunately this is missing.  This is likely to be due to the fact that when Chapter 4 was last updated (June 2011) there was no mention of a Quality Manual in Chapter 1 at that time, which was then later updated in January 2013.  Hopefully any future update of Chapter 4 will include more detail of what should be contained in a Quality Manual.

We can though turn to ICH Q10 (the Pharmaceutical Quality System) where additional guidance is also provided as to the contents of a Quality Manual.  Clause 1.8 states:

A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system.  The description should include:

(a) The quality policy

(b) The scope of the pharmaceutical quality system

(c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and interdependencies.  Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner

(d) Management responsibilities within the pharmaceutical quality system

In other words the Quality Manual should contain

  • the Quality Policy (which provides direction and a vision for an organisation),
  • the scope of the QMS (what parts of the organisation does the QMS cover or not cover),
  • the pharmaceutical quality system processes (what are the key activities that occur at the organisation – such as purchasing, goods-in, manufacture, testing, etc.)
  • as well as management responsibilities (who are Senior Management and what is their involvement with the QMS).

Quality Manual Structure

It is normal for a Quality Manual to be structured around the standard on which it is based, and so if a Quality Manual is based around the requirements of EU GMP, then it is normal to have a section of the Quality Manual corresponding to each of the nine chapters of EU GMP.  Poor Quality Manuals normally involve simply copying the requirement of the standard into the manual itself.  This is of little value.  A good Quality Manual covers HOW an organisation intends to achieve the requirement of the standard that it is based on, for example:

  • how are People looked after (matching Chapter 2 of EU GMP),
  • how are suitable Premises and Equipment maintained (matching Chapter 3 of EU GMP) and
  • how Documents and Records controlled (matching Chapter 4 of EU GMP),
  • and so on.

A Quality Manual is a very useful document that not only gives guidance and direction to an organisation’s own personnel, but gives a potential customer, inspector or auditor an appreciation of an organisation from the outside.  If designed well it can be used as a tool to sell an organisation, to show what a positive quality ethos they have and can show how good an organisation is and how seriously it takes its Quality Management System.

Have you any comments on this approach?

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

Our 2-day course is updated for Annex 1 changes

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