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.
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.
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
IMPORTANT: TRANSITION FROM PS 9000:2011 TO PS 9000:2016
- Transition from PS 9000:2011 to PS 9000:2016 is expected to be completed by 15 September 2018
- PS 9000:2011 certifications may still be issued up to end September 2017, however they will no longer be valid after 15 September 2018
- Certification to PS 9000:2016 can be included within re-certification audits from the date of the launch of the standard providing the requirements of the standard are met
Further information is available in the pages following on:
- Companies that have been approved as PQG Certified Suppliers
- Independent organisations that can certify suppliers and others that can provide training for auditors
- How to become a Certified Supplier
For further information please contact PQG Certification.