GMP Compliance and Auditing for Biopharmaceutical/Biologic APIs

Industry field:

Biopharmaceutical industry

Course description:

Recent FDA Warning Letters stress the reality that compliance requirements for biopharmaceuticals/biologics are different and more stringent than traditional pharmaceuticals. Biopharmaceutical/Biologic firms face a host of unique compliance issues, particularly given the fact that microorganisms can degrade biopharmaceutical/biologic products. In addition, industry trends toward the use of contract and/or multi-product manufacturing emphasizes the need for personnel to better understand these evolving regulatory compliance expectations. This course reviews and interprets the specific GMP requirements from FDA for biopharmaceuticals/biologic Active Pharmaceutical Ingredients (APIs), provides a foundation for compliance personnel and auditors to focus on the most critical compliance problems, and offers suggestions for effective quality systems.

This two-day course reviews the applicable FDA regulations and guidance documents including the ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7). Interpretation of the regulatory expectations is facilitated through a review of relevant FDA Warning Letters, 483 observations, typical inspector questions, and current industry standards. Case studies are offered throughout the course to more effectively integrate the principles presented.

Who should attend:

This course is designed to provide a basic overview of critical regulatory compliance issues specific to Active Pharmaceutical Ingredient (API) biopharmaceutical/biologics, based on ICH Q7 and an FDA perspective. Personnel in QA, QC, Regulatory, and Manufacturing involved in ensuring GMP compliance and/or performing compliance audits should attend. Course assumes the attendee has a basic understanding of the GMP regulations.

Learning objectives:

This course is designed to provide an introductory overview and interpretation of FDA compliance requirements specific to manufacturing Active Pharmaceutical Ingredient (API) biopharmaceuticals/biologics based on ICH Q7 and other relevant FDA and ICH guidance documents. One of the primary goals of the course is to provide the attendee sufficient understanding of the most critical regulatory inspection issues in order to be able to participate in building effective compliance programs and/or perform effective compliance audits.

Course outline:

• Introduction
• Course Strategy
• Structure of FDA
• GMP Principles
• Regulatory Documents
• Facilities and Environmental Monitoring
• Facility Design
• Regulatory Guidance
• Multi-product Facility Considerations
• Environmental Monitoring
• Area Classifications
• Sampling and Testing Programs
• Limits
• Investigations
• Trending
• Case Study: Facility Flow Diagram and Area Classification
• Manufacturing Compliance
• Fermentation/Cell Culture
• Transfers and Feeds
• In Process Monitoring
• Trending
• Recovery/Cell Processing
• Centrifugation
• Filtration
• Capture Chromatography
• Purification
• Viral Inactivation
• Chromatography
• Ultrafiltration/Diafiltration
• API Handling
• General Topics
• Filtration
• Media/Buffer/Solution Prep
• In-Process Testing
• Double Checks
• Cleaning Issues
• Use of Disposables
• Contamination Control and Process Bioburden Monitoring
• Raw Material Compliance
• Contamination Control
• Critical Materials
• Materials Control
• Supplier Qualification
• Cleaning Validation/Verification
• Cleaning Procedures
• Sampling and Testing Methods
• Acceptance Limits
• Special Considerations for Multi-product facilities
• Routine Monitoring
• Cleaning Verification
• Changeover
• Case Study: Understanding Acceptance Limits
• Process Validation
• Definitions
• New FDA Guidance
• Process Validation Program Documentation
• Quality by Design (QbD)
• Biotechnology Product-Specific Support Studies
• Continued Process Verification
• Case Study: Evaluating Parameters
• Cell Banking
• Introduction
• Why High Level of Compliance
• Facilities and Equipment
• Raw Materials
• Manufacturing
• Testing
• Storage and Access

Course facts

Do you want our newsletter?

» Make sure to get the latest information

» Tip a colleague