PQG Supplier Auditor Certification and Training scheme

1. PQG Supplier Auditor Certification and Training scheme Introduction to the scheme & implications of the changes David Mogg PQG Chairman

2. Overview • Auditor Certification is covered by the PQG document 602: • Pharmaceutical Supplier Auditor Certification Scheme ‘The PS Scheme’ • Training courses are covered by IRCA document 2235: • Certification criteria for the ISO 9000:2000 Series and Pharmaceutical Supplier auditor/lead auditor training course

3. Auditor Certification • The PS Scheme is intended for: • Quality auditors who audit suppliers to the pharmaceutical industry • PQG 602 provides information and instructions additional to requirements laid down by IRCA 602 ‘QMS 2000’. • The PS Scheme has two grades of certification: • PS Auditor • PS Lead Auditor • equivalent to IRCA QMS 2000 certification grades

4. Auditor Certification • To be eligible for PS Scheme certification, applicants must be certified as an IRCA QMS: • 2000 Auditor • Lead Auditor • Principal Auditor • or meet the requirements for such certification • The PS Scheme Lead Auditor grade is equivalent to the IRCA QMS 2000 Principal Auditor grade.

5. Training Course Certification • The International Register of Certificated Auditors (IRCA) and the Pharma Quality Group (PQG) have prepared the criteria to help the approved training organization to achieve certification of an ISO 9000:2000 series & Pharmaceutical Supplier auditor/lead auditor (PS) training course.

6. Current Situation • Auditors • 38 have successfully achieved ISO 9000:2000 series & Pharmaceutical Supplier auditor/lead auditor status: • 19 Industry • 13 Certification Bodies • 4 Independent Consultants • 2 MHRA • 27 Leadauditors • 9 Auditors • 2 Auditors (Provisional) • 14 listed on PQG web site having given the PQG permission to publish their details: • 13 Leadauditors • 1 Auditor

7. Current Situation • Training Providers • 2 listed on PQG web site • Both in the south of England • A third showing interest in being certified

8. More Information Available … • Training Providers http://www.pqg.org/publications/psseries/certsupp.php • Auditors http://www.pqg.org/publications/psseries/auditors.php

9. The Future • The PQG, together with the Training Course providers, will assure that the courses reflect ISO 15378 and IPEC – PQG as well as current regulatory requirements • There will be transitional period, to be confirmed with the providers but of the order of 12 months • If Primary suppliers seek certification, then the route can be via ISO 15378 or PS 9000 • For Secondary (Print) suppliers, the route will continue to be PS 9000 alone

10. The Future • The PQG web site will provide more detailed information for pharma companies seeking both: • Certified suppliers • Certified auditors • Copies of certificates: • Better descriptions of the skills and expertise of the supplier or auditor • Easy access to confirmation of the supplier or auditors current status • Contact details: • E-mail, Telephone, Address

11. The Future • The PS series standards, including the Training Manual, PS 9004, will continue to be valuable documents: • Manageable format • Ease of reading • User guidance based on practical experience of the authors • But not forgetting that, in many respects, ISO 15378 and the IPEC – PQG guides are more demanding than the PS standards: • Validation and Risk Assessment, Annexes B & C are much more extensive than PS 9000 • ISO 15378 is more prescriptive and lacks the 'guidance style’contained in PS 9000, which also has PS 9004 as an aid. • Issues like TSE are included in ISO 15378,(which are usually associated with Actives and Excipients).

12. The Future • The PQG will continue to: • provide new standards and monographs • assist suppliers, the industry and regulators apply consistent, agreed standards to areas of risk • increase its global role in influencing the establishment of standards and the reduction of risk to our customers Thank you