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Auditing Biopharma APIs


Auditing Biopharma APIs
API GMPs Training
Process Validation
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Auditing and Compliance for Biopharmaceutical APIs 

Approximate Time: 3 days (including class exercises)

Course description: 

This course reviews and interprets the technology and current FDA compliance requirements for the production and testing of biopharmaceutical APIs, and discusses the critical issues to consider when conducting an effective and efficient GMP audit.  Utilizing a risk-based approach to compliance, as part of implementing the FDAs Quality Systems Approach to CGMP, is emphasized.

The topics reviewed during this course include an overview of the technologies and the basic compliance requirements for biopharmaceutical APIs. Applicable FDA guidance in each area will be reviewed and interpreted along with recent regulatory observations. Topics are categorized and presented utilizing the FDAs Six-system Inspection Model. Critical aspects of each system that are specific to biopharmaceutical APIs and should be considered during a successful audit will be highlighted and successful preventive measures and solutions will be discussed.

Class exercises and case studies will help attendees to gain hands on experience in how to apply regulatory interpretations to real life situations. Throughout the course, examples will be used to highlight the points made.  Current industry hot topics will be presented along with an explanation of the associated regulatory concerns.  

Course Topics include:     Detailed Outline


Quality System

Adequacy of Biopharmaceutical Investigations



Facilities and Equipment System

Facilities and Equipment: Design for Contamination Control


Environmental Monitoring and Exceeded Limit Investigations


Understanding Equipment Cleaning, Sterilization and Sanitization (including CIP and SIP)


Cleaning Validation/Verification including Multi-product Equipment


Computerized Systems: Control for Part 11 Compliance



Materials System

Critical Materials (including Animal Sourced)


Supplier Qualification


Master and Working Cell Bank Generation, Characterization and Maintenance



Production System

Recombinant DNA Technology


Fermentation/Cell Culture Technology and Processes including Inoculum Preparation, Control Systems and Monitoring


Harvesting and Recovery Techniques and Processes including Centrifugation, Filtration and Capture Chromatography


Purification Techniques including Chromatography, Ultrafiltration/Diafiltration, Viral Inactivation/Removal, and Crystallization


Aseptic Operations in the Biotech Process


Established Life Span for Chromatography Columns and UF Membranes


Ongoing Process Monitoring including Bioburden Control



Laboratory System

Biotech Laboratory Techniques for Identity, Potency and Purity including ELISA, HPLC, DNA, LAL, Electrophoresis, and Cell-based Assays


Critical Laboratory Systems including Sample Handling, OOS Results, Critical Reagents, and Standards


API and Intermediate Stability



Packaging and Labeling System

API Container/Closure Validation

Learning Objectives:

This course will provide the attendees with a basic technical knowledge of biopharmaceutical processes and their support functions and a thorough overview of all related GMP compliance issues.  It will emphasize those issues that are currently gaining significant regulatory attention, as well as those that pose the greatest risk to the safety, identity, strength, quality or purity of the API.

Who should attend:

This course is intended for Quality Assurance and Production biopharmaceutical professionals.  Regulatory Affairs, Research and Development, Quality Control, and Validation professionals involved in the support of biopharmaceutical APIs should also attend.


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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

Copyright 2003 Compliance Net, Inc.

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