In the absence of mandatory GMP standards for the manufacture and supply of pharmaceutical packaging materials, the PQG developed the PS 9000 standard for Pharmaceutical Packaging Materials (incorporating ISO 9001). This well used standard is recognised and acknowledged by the UK MHRA.
Certification to the PQG Certified Supplier scheme is given by independent, accredited, certification bodies to suppliers to the pharmaceutical and related industries that meet expected standards. Suppliers certified to the PQG scheme are entitled to use PQG Certified Supplier logos on their company literature, which indicates to the pharmaceutical industry that they conform to the GMP standards expected for suppliers to the industry.
BSI are currently the only PQG approved Certification Body for supplier certification to the PS9000 standard and entry onto our Certified Supplier list. Contact Janet Henesy
Suppliers certified prior to Oct-2019 by Certification Bodies BV, DNV, LRQA and NSAI, who were formerly part of the scheme, remain Certified Suppliers until the expiry date of their current certificates.
Any Certification Bodies wishing to join the scheme should contact PQG Certification
To be eligible for PQG Certified Supplier status, all assessments must be carried out by auditors who are certified by IRCA for QMS to the current ISO 9001 standard and trained in PS 9000 and other standards as appropriate to the assessment. Only auditors that have met the requirements of the PQG approved PS 9000 training course can verify that suppliers are complying with the standards required to become a PQG Certified Supplier. This training may be carried out by a PQG approved independent training organization or by a PQG approved certification body. Auditors are required to be employed by a PQG Approved Certification Body in order to perform certification audits.
Current PQG approved independent training organisations for PS 9000 are:
A Scheme requirements document giving the various responsibilities of the Organisation seeking certification, PQG, the third party Auditor and the accredited Certification Body may be found HERE
Further information on companies that have been approved as PQG Certified Suppliers
For further information please contact PQG Certification.