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.
In this webinar our speaker Peggy Berry will 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.
Learning Objectives:
- 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
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.
Topics
- Regulatory requirements for APIs and Excipients
- Current GMP requirements for APIs, Excipients and Drug Products
- Role of the raw materials laboratory within the pharmaceutical supply chain
- Sampling of incoming APIs and Excipients
- Reduced testing of supplied APIs and Excipients
- 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?
- Metrics to monitor suppliers?
Instructor
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.
Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).
She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).
In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).