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 GMP Compliance for Biopharmaceutical API Manufacturing

Approximate Time: 3 days (including class exercises)

Who Should Attend:

This course is designed to provide a basic 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 specific GMP requirements for bulk biopharmaceuticals, discusses how to avoid common compliance problems, and offers suggestions for effective quality systems.

The areas reviewed in the course include those topics where compliance requirements differ most from traditional pharmaceuticals. Each topic will be reviewed in a similar format including, first, a review of the interpretation of the regulatory requirements stated in the ICH Active Pharmaceutical Ingredient Good Manufacturing Practice document (Q7A) as well as other pertinent ICH and FDA guidelines. This will be followed by a discussion of relevant 483 observations (with a focus on Team Biologics inspections), typical inspector questions, and some practical solutions for implementing and/or improving GMP quality systems. 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. Hands on workshops are offered throughout the course to allow the participants to apply and integrate the principles presented. Course Topics include:

bulletFacility Design and Environmental Monitoring 
bulletClass Exercise: Facility Airflows and Environmental Program
bulletRaw Materials: Testing and Vendor Programs 
bulletManufacturing Compliance 
bulletClass Exercise: Master Batch Record Compliance 
bulletLaboratory Compliance 
bulletCleaning Validation 
bulletProcess Validation 
bulletClass Exercise: Determination of Critical Variables and Ranges 
bulletCell Banking Compliance


NOTE:  This course is also offered as a two hour overview.  The same material is covered, but with fewer details and no class exercises.


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FDA on Training

Once the API starting material is introduced into the API process, manufacturers should increase GMP controls according to some reasonable and scientifically sound rational as processing proceeds from early process steps to final synthesis, isolation and purification steps. Of course, the degree of control depends on the process and manufacturing stage.

Edwin Rivera Martinez, FDA
Presentation at joint PDA/FDA
September 2001

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