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Overview of GMP Compliance for Biopharmaceutical API Manufacturing

Approximate Time: 2 hours

Who Should Attend:

This course is designed to provide a quick overview of issues specific to Active Pharmaceutical Ingredient (API) biopharmaceutical compliance based on ICH Q7A. Personnel in QA, QC, Regulatory, and Manufacturing involved in ensuring GMP compliance should attend. Course assumes the attendee has a basic understanding of the GMP regulations. 

Course Description: 

Firms involved in the manufacture of Specified Therapeutic Biotechnology-Derived Pharmaceuticals face a host of compliance issues unique to their processes and associated analytical testing. This course reviews and interprets the most critical GMP requirements that are specific for bulk biopharmaceuticals.  FDA's Interpretations of ICH Q7A (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients) are included throughout the course.

The areas reviewed in the course include those topics where compliance requirements differ most from traditional pharmaceuticals. Common deficiencies and problem areas are reviewed, while providing recommended systems, controls and procedures to avoid these pitfalls. The course focuses on building solid GMP Principles based on the concepts of Quality Assurance and using sound, scientific principles to build compliant systems. Participants develop the ability to ask the right questions based upon science and the regulations. 

Course Topics include:

bulletAPI GMPs History
bulletIntroduction to API GMPs
bulletQuality Management
bulletBuildings and Facilities
bulletProcess Equipment
bulletDocumentation and Records
bulletMaterials Management
bulletProduction and In-process Controls
bulletLaboratory Controls
bulletQualification and Validation
bulletScope of Q7A
bulletSpecifics for Biotech
bulletSpecifics for Clinical Manufacturing

NOTE:  This course is also available in an expanded 3 day version that covers many more details of the applicable regulations, as well as including many more examples and participant exercises to ensure the material has been assimilated.


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Edwin Rivera Martinez stressed that GMPs are not less important for APIs, it's just that they are applied differently because of differences in the manufacturing process. Additionally, he cautioned "the uniqueness of API processes does not influence FDA expectations for GMP compliance in the testing laboratory." Mr. Martinez stated "As far as FDA is concerned a lab is a lab is a lab." 

Edwin Rivera Martinez, FDA 
PDA/FDA Q7A Training Workshop
February 2002

Copyright 2003 Compliance Net, Inc.

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