Auditing to Pharmaceutical Standards

1 Day/s

CPD Hours: 7

Classroom, online, in-house

It is a regulatory requirement for organisations within the Pharmaceutical and Allied Industries to audit active pharmaceutical ingredient (API) manufacturers, suppliers of key excipients and packaging materials, and contracted-out laboratory services. This course is aimed at reviewing the key relevant standards that one might expect to audit against, providing a strong foundation for the application of auditing skills. Specifically this course covers the EU GMP Parts I, II and III; PS 9000; ISO 17025; ISO 15378 and ISO 13485. Several elements of ISO 9001 (Quality Management Systems) are explored in detail.

The course is suitable for all those who need an appreciation of the above standards in order to audit within the pharmaceutical industry and allied industries, particularly those who undertake external supplier audits. In addition to those with a dedicated auditing role, it is also suitable for Qualified Person’s (QP).
The course covers the following topics:

  • EU Guide to GMP and supplier requirements
  • ISO 9001
  • Excipients
  • Packaging: PS9000 and ISO 15378
  • ISO 17025 (Contract Testing)
  • GDP
  • Medical Devices ISO13485

    By the end of the course you will be able to understand the structure and key requirements of:

    • EU GMP Part I - Basic Requirements for Medicinal Products
    • EU GMP Part II - Basic Requirements for Active Substances used as Starting Materials
    • EU GMP Part III - ICH Q9, ICH Q10, ISO 9001 - Quality Management Systems
    • PS 9000 - application standard Good Manufacturing Practice relating to the manufacture of packaging materials for medicinal products
    • EXCiPACT and IPEC/PQG GMP guide for pharmaceutical excipients
    • ISO 17025 - competence of testing and calibration laboratories
    • ISO 13485 - Quality management systems for Medical Devices
    • ISO 15378 - Primary Packaging Materials
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Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.

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