Auditor Training: Excipients and APIs

Why Should You Attend:

Compliance with the previous Annex 18 regulations for active pharmaceutical ingredients (APIs), EU GMP Part I, was on a voluntary basis and was in line with the EU’s agreement to ICH Q7A guidance. Since 2004 Article 46(f) of Directive 2001/83/EC and Article 50 of Directive2001/83/EC, as amended by Directives 2004/27/EC and 2004/28/EC respectively, mandate manufacturing authorisation holders to only use active substances that have been manufactured according to Good Manufacturing Practice for starting materials. This was then broadened to include excipients, therefore, the course includes requirements from the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (2006).

This webinar is designed for quality professionals who may or may not have external auditing experience to give a thorough background on auditing suppliers of excipients and active pharmaceutical ingredients (APIs) to the pharmaceutical industry. It will further provide guidance on consistent reporting of findings and will emphasize the differences from regular final drug product auditing.

This webinar is geared towards those taking part in supplier audits for the first time, as well as more experienced auditors with a good manufacturing practice (GMP) or wider GxP background.

Areas Covered in the Webinar:

• EU GMP Guide Part II: Basic Requirements for Active Substances Used as Staring Materials
• The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (2006)
• Provide auditors of pharmaceutical ingredients with the knowledge and skills awareness to plan, conduct and report an effective audit of API and excipient manufacturers
• Promote a systematic approach to auditing suppliers of pharmaceutical ingredients
• Guidance on consistent reporting of findings
• Differences from regular final drug product auditing, with a look at regular supply of API and excipients for marketed drugs as well as what to expect with supply of APIs for new products under development

Who Will Benefit:

• Quality auditors
• Quality professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Process owners
• Procurement officers

Madeleine Fairweather
GMP Auditor & consultant, MSF QA Associates Limited

Madeleine S. Fairweather Ph.D., MRSB, currently works as an independent auditor and training consultant in GxPs, and as part-time Regulatory Standards Manager for Labcold Ltd., UK, who specialize in the manufacture of blood banks, plasma freezers and pharmacy refrigerators. Her background is in manufacture and supply of biological-based APIs such as therapeutic antibodies and anti-toxins derived from fresh-frozen plasma, as well as recombinant DNA vaccines.

Ms. Fairweather has been involved in technology transfer and ongoing auditing of API suppliers for over ten years which took her to the US, Australasia and Asia. She has successfully ensured the manufacturing quality of products and guided suppliers to achieving their MHRA, FDA and TGA licenses. Further API and excipient experience has been gained through auditing for OTC medicines and antibiotics.

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