This course supplements the "CGMP Interpretation and Application" course with the review of the current FDA requirements and expectations, and the interpretation and application of GMPs (21CFR211) for the production and control of Bulk Pharmaceutical Chemicals (BPCs) and Active Pharmaceutical Ingredients (APIs). The review and interpretations are based on published FDA and ICH guidelines and guidance documents. The main focus of this course is a comparative analysis of the published GMPs in 21CFR211 with the required and proposed GMPs for BPCs and APIs, to identify the additional GMP requirements, and the flexibility and exemptions of 21CFR211, for application to BPCs and APIs. This course includes group discussions of specific GMP compliance issues related to BPCs and APIs.
The course participants will gain the knowledge and skills to differentiate and effectively apply the GMP requirements for the production and control of BPCs and APIs, with the support of published regulatory references.
This course is intended for all Quality Assurance, Laboratory, Compliance, Production and Regulatory Affairs professionals. This course is also beneficial for professionals who support the BPC/API operations (e.g., Engineering, Purchasing and Materials Management).