7th February 2006 1

PQG Supplier Auditor Certification and Training scheme

Introduction to the scheme & implications of the changes

David MoggPQG Chairman

7th February 2006 2

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

7th February 2006 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

7th February 2006 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.

7th February 2006 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.

7th February 2006 6

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

7th February 2006 7

Current Situation

• Training Providers• 2 listed on PQG web site

• Both in the south of England

• A third showing interest in being certified

7th February 2006 8

More Information Available …

• Training Providershttp://www.pqg.org/publications/psseries/certsupp.php

• Auditorshttp://www.pqg.org/publications/psseries/auditors.php

7th February 2006 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

7th February 2006 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

7th February 2006 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).

7th February 2006 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