Standards to use when auditing suppliers -with links to the key standards

If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. These could be suppliers of chemicals and packaging components, as well as suppliers of analytical testing or calibration services. GMP does not really tell you what pharmaceutical supplier standards you should or could use when auditing your suppliers. So, below is a list of all the key standards to use when auditing suppliers to GMP requirements including links to all of the key documents and authorities.

Type of supplier	Standard to use	Available from
Active ingredients	Use Active Pharmaceutical GMP (EU GMP Part 2 or ICH Q7)	Available for free from the European Union’s Eudralex website.
Excipients (chemicals that are not the active ingredient)	Use the Joint IPEC – PQG Good Manufacturing Practices Guide for pharmaceutical excipients	Available for free from the International Pharmaceutical Excipient Councils (IPEC’s) website.
Contact packaging materials	Use either *ISO 15378 (Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001, with reference to GMP)* or PS 9000 (Pharmaceutical Packaging Materials for Medicinal Products)	Available to buy from the International Standards Organisation’s website Available for free from the Pharmaceutical Quality Group’s website.
Packaging materials	Use PS 9000 (Pharmaceutical Packaging Materials for Medicinal Products)	Available for free from the Pharmaceutical Quality Group’s website.
External testing laboratories	Use ISO 17025 (General requirements for the competence of testing and calibration laboratories) AND relevant parts of GMP (such as Chapter 6 of EU GMP)	Available to buy from the International Standards Organisation’s website Available for free from the European Union’s Eudralex website
Calibration companies	Use ISO 17025 (General requirements for the competence of testing and calibration laboratories)	Available to buy from the International Standards Organisation’s website
Contract manufacturers	Use the relevant GMP standard for the country or region that they are in, such as EU GMP	Available for free from the European Union’s Eudralex website.
Transportation companies	Use the EU’s Good Distribution Practice (GDP) guidelines	Available for free from the European Union’s Eudralex website
Other suppliers	Use ISO 9001 (Quality management systems – Requirements)	Available to buy from the International Standards Organisation’s website

I hope that list of standards to use when auditing suppliers is helpful. Feel free to add any comments or any additional guidelines and standards that may be of interest. If you are interested in supplier auditor training, then do consider our IRCA registered PQMS Pharmaceutical Lead Auditor training course.

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 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.

More details