Quality Control of Raw Materials (APIs and Excipients)
Duration: 90 Minutes
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.
Objectives of the Presentation
Why Should you Attend
- 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
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.
Who will Benefit
- 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?
- Senior management
- Production management
- Quality management
- Quality Assurance
- Quality Assurance Product Reviewers
- Quality Assurance Managers
- Quality Control Managers/Supervisors
- Process and Design Engineering Personnel
- Process Automation Staff
- Manufacturing Operations Staff
- Validation Specialists
- Utility Operations Staff
- Regulatory Affairs Personnel