Scope
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.
Suitability
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).
Learning Outcomes
By the end of the course you will be able to understand the structure and key requirements of:
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EU GMP Part I - Basic Requirements for Medicinal Products
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EU GMP Part II - Basic Requirements for Active Substances used as Starting Materials
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EU GMP Part III - ICH Q9, ICH Q10, ISO 9001 - Quality Management Systems
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PS 9000 - application standard Good Manufacturing Practice relating to the manufacture of packaging materials for medicinal products
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EXCiPACT and IPEC/PQG GMP guide for pharmaceutical excipients
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ISO 17025 - competence of testing and calibration laboratories
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ISO 13485 - Quality management systems for Medical Devices
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ISO 15378 - Primary Packaging Materials
