Good Manufacturing Practice regulations (GMPs) are used by pharmaceutical, medical device and food manufacturers as they produce and test products that people use. This course explores the regulations through which the Federal government controls the drug, cosmetics and diagnostic industries. Major emphasis is placed on understanding the need for and the intent of regulations and developing mechanisms for implementation and compliance. This course is intended to give participants an introduction to GMPs regulations and their application to laboratory studies and manufacturing processes.
It will also provide participants with an understanding of terminology and the role GMPs play in assuring their validity. Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation.
This course introduces students to the principles of GLP/GMP in the pharmaceutical and associated industries with the emphasis on the necessary procedures and documentation required to achieve full compliance.
Upon completion of this course, students will have an understanding of the various aspects of GMP regulations including:
- Attributes of materials, including formulation components, container and closure systems, labels and labeling, materials in process, and finished pharmaceuticals.
- Methodology, including documentation, manufacturing validation, quality assurance, quality control, and supportive manufacturing operations.
- Personnel and facilities, including building, equipment, instruments and infrastructure.
- Analytical and laboratory validation and compliance programs.
- Module 1 – Good Manufacturing Practices, Quality Assurance And Regulation
- Module 2 – Quality Assurance And Control
- Module 3 – Quality Assurance of Pharmaceuticals (Vol II)
- Module 4 – SCHEDULE -M
Any Science Graduate