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PQG Supplier Auditor Certification and Training scheme

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PQG Supplier Auditor Certification and Training scheme Introduction to the scheme & implications of the changes David Mogg PQG Chairman Overview Auditor Certification ... – PowerPoint PPT presentation

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Title: 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
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