cGMP in API Manufacturing

Length: 2 Days

This comprehensive training course provides an in-depth understanding of current Good Manufacturing Practices (cGMP) in Active Pharmaceutical Ingredient (API) manufacturing. Participants will gain insights into regulatory requirements, industry best practices, and key concepts essential for ensuring quality, safety, and compliance in API manufacturing processes.

Learning Objectives:

  • Understand the principles and importance of cGMP in API manufacturing.
  • Familiarize with regulatory requirements governing API manufacturing.
  • Learn industry best practices for maintaining quality and compliance.
  • Identify critical aspects of API manufacturing processes and associated challenges.
  • Gain practical knowledge to implement effective cGMP strategies in API manufacturing facilities.
  • Enhance skills to mitigate risks and optimize operational efficiencies in API manufacturing.

Audience: This course is designed for professionals involved in API manufacturing, including:

  • Quality Assurance/Quality Control Managers
  • Production Managers
  • Regulatory Affairs Personnel
  • Manufacturing Engineers
  • Compliance Officers
  • Process Development Scientists

Course Outline:

Module 1: Introduction to cGMP: Fundamentals and Regulatory Overview

  • Overview of cGMP Principles
  • Regulatory Agencies and Guidelines
  • Importance of cGMP in API Manufacturing
  • Key Elements of cGMP Compliance
  • Historical Perspectives on cGMP Evolution
  • Role of cGMP in Ensuring Product Quality and Patient Safety

Module 2: Quality Systems in API Manufacturing

  • Quality Management Systems (QMS)
  • Risk Management in API Manufacturing
  • Change Control Procedures
  • Deviation Management
  • CAPA (Corrective and Preventive Action) Processes
  • Supplier Qualification and Management

Module 3: Facility Design and Maintenance for cGMP Compliance

  • Facility Layout and Design Considerations
  • Cleanroom Design and Operation
  • Equipment Qualification and Calibration
  • Environmental Monitoring
  • Hygiene and Sanitation Practices
  • Pest Control Measures

Module 4: Process Validation and Control Strategies

  • Principles of Process Validation
  • Process Analytical Technology (PAT) in API Manufacturing
  • Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
  • Batch Record Review and Approval
  • In-process Controls and Sampling Plans
  • Continuous Process Verification (CPV)

Module 5: Documentation and Record-Keeping Requirements

  • Documentation Practices in cGMP Environment
  • Batch Record Documentation
  • Change Control Documentation
  • Record Retention and Archiving
  • Electronic Data Integrity
  • Training Documentation and Records

Module 6: Handling Non-conformities and Corrective Actions in API Manufacturing

  • Non-conformity Identification and Reporting
  • Root Cause Analysis Techniques
  • Corrective Action Plan Development
  • Preventive Action Implementation
  • Effectiveness Monitoring and Verification
  • Continuous Improvement Initiatives