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 StandardsOrganisation’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 |