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 90002000
  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 90002000 series
  Pharmaceutical Supplier auditor/lead auditor (PS)
  training course.

6
Current Situation

• Auditors
• 38 have successfully achieved ISO 90002000
  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
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 stylecontained 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