1. 7th February 20061 PQG Supplier Auditor Certification and Training scheme Introduction to the scheme & implications of the changes David Mogg PQG Chairman

2. 7th February 20062 Overview Auditor Certification is covered by the PQG document 602: Training courses are covered by IRCA document 2235: Pharmaceutical Supplier Auditor Certification Scheme ‘The PS Scheme’ Certification criteria for the ISO 9000:2000 Series and Pharmaceutical Supplier auditor/lead auditor training course

3. 7th February 20063 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. 7th February 20064 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. 7th February 20065 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. 7th February 20066 Current Situation Auditors 38 have successfully achieved ISO 9000:2000 series & Pharmaceutical Supplier auditor/lead auditor status: – 27 Lead auditors – 9 Auditors – 2 Auditors (Provisional) – 19 Industry – 13 Certification Bodies – 4 Independent Consultants – 2 MHRA 14 listed on PQG web site having given the PQG permission to publish their details: – 13 Lead auditors – 1 Auditor

7. 7th February 20067 Current Situation Training Providers 2 listed on PQG web site Both in the south of England A third showing interest in being certified

8. 7th February 20068 More Information Available … Training Providers http://www.pqg.org/publications/psseries/certsupp.php Auditors http://www.pqg.org/publications/psseries/auditors.php

9. 7th February 20069 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. 7th February 200610 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. 7th February 200611 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. 7th February 200612 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