It is the responsibility of a manufacturer to assure that all its suppliers are compliant with FDA’s current GMP requirements applicable to their operations. Supplier management starts with appropriate qualification, contracts, and quality agreements, and requires continuing quality assurance (QA) practices including sampling and testing, and supplier audits. FDA compliant quality systems require a vigorous supplier qualification process and robust quality agreements with all suppliers. The recently proposed FDA Draft Guidance on Quality Agreements describes the relationship between owners and contractors, and defines all the expectations for both parties when it comes to complying with GMP requirements.
In this 90 minute session, Dr. Mukesh Kumar will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA findings related to suppliers during GMP audits will be discussed with potential remedies. Mukesh will shed light on FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. Content and structure of SOPs for supplier qualification and quality agreements will also be discussed, along with the Common FDA audit findings.
Plus, the US regulations will be compared with those in the EU to identify common themes across different regulatory agencies and ways to comply.
Areas covered in the session:
Suppliers form a critical element of the GMP compliance status of a manufacturer. Supplier could be used for pretty much any aspect of manufacturing such as raw material, components, packaging, shipping, and even finished product. It is the responsibility of the manufacturer to assure that all its suppliers are compliant with FDA’s current GMP requirements. This session will describe FDA’s expectations from manufacturers and suppliers alike.
Who should attend?
- Dr. David Lim
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
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