Standards to use when auditing suppliers

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.