Quality Control of Raw Materials (APIs and Excipients) in the Pharmaceutical Industry

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Aug 17, 2016
90 minutes
Product Description

GMP Regulations That Apply to the Testing and Receipt of APIs, Excipients & Other Components in the Pharma Industry

A number of observations on FDA over the past several years reveal that pharmaceutical firms have not been performing adequate testing for incoming APIs, components and raw materials. The regulatory requirements are defined in the GMPs. Because of recognized problems in the incoming material supply chains, the agency is placing more emphasis on material quality. If you make such observations as your base, it appears that some organizations have chosen to ignore/misinterpret the regulatory expectations.

As the pharmaceutical industry goes global, it has become more difficult to assure the quality of actives and excipients. The incoming inspection is the last control point before a material is incorporated into the pharmaceutical product. It is important that the pharmaceutical has in place effective systems for ensuring the quality of actives, excipients and components.

Join this session by expert speaker Dr. Jerry Lanese to discuss the regulations within GMPs which apply to the testing and receipt of APIs, excipients as well as other components found in a pharmaceutical product. The session is going to include reference according to specific observations on FDA, have an analysis of what actually happened, and actions to avoid practical considerations and similar observations to achieve compliance with FDA expectations. The session will also help personnel in the quality control laboratory understand the FDA expectations for incoming materials testing and the role of Quality Control in achieving compliance in the area of incoming material testing and release.

Why Should You Attend:

Testing active pharmaceutical ingredients and excipients is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the starting materials are released only after their quality was judged as satisfactory. This webinar about the incoming goods control of APIs and excipients will give you a comprehensive overview of the specific tasks and questions of the “raw materials lab“ and show you real-life solutions and answers.

Session Highlights:

  • Regulatory requirements needed to test and release APIs, raw materials, excipients and pharmaceutical product components.
  • FDA observations related to testing and release of raw materials, excipients and components.
  • Regulatory expectations to test and release incoming APIs, raw materials, excipients and pharmaceutical product components.

You will also get answers to the following tough questions:

  • What is the most frequently occurring observation that relates to testing and release of components?
  • How does a manufacturer verify or qualify a laboratory for a test that its laboratory cannot perform?
  • Who in the organization should be responsible for the Supplier Qualification Program?
  • If activities that pertain to incoming material receipt and release occur in different parts of the organization and all of the involved individuals need to be trained. Who should be responsible for training for the receipt and release of components?
  • How often should your organization “requalify” or “reverify” a supplier?
  • Since the FDA appears to be interested in metrics, which are the best metrics to monitor suppliers?

Who Should Attend

  • Development personnel who identify and negotiate agreements with API, raw material and component suppliers.
  • Quality and purchasing personnel who identify API, raw material and component suppliers and develop and negotiate quality agreements with material and component suppliers.
  • Quality personnel responsible for the preparation of specifications and test methods for incoming materials.
  • Quality Control personnel who are responsible for the testing and release of API, components and raw materials
  • Quality Assurance personnel responsible for the release of API, raw material and components

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...   More Info
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