Good Manufacturing Practices for Active Pharmaceutical Ingredients per ICH Q7 2018

Topics

• Buildings and Facilities- including design and construction, utilities, water, etc
• Roles of Quality Management, Quality personnel, Production management and Production personnel in ensuring GMP manufacture of APIs under an appropriate system for managing quality will be covered. SOPs required for items, as stated in the guidance document, will be included
• Documentation and Records, including Documentation system and specifications, Equipment records, Records of raw materials, intermediates, API labelling and Packaging materials, Master Production, Batch Production and Lab Production records and the review of batch records
• Process Equipment, including design/construction, maintenance, cleaning, calibration, computerized systems
• Packaging/identification labelling of APIs and Intermediates
• Materials Management, receipt/quarantine, Sampling and testing of incoming production materials, storage
• Laboratory Controls, including testing of intermediates and APIs, Validation of Analytical Procedures, C of As, Stability Monitoring, Expiry dating
• Storage and Distribution
• Change Control, Complaints and Recalls, Rejection and Re-use of Materials
• Validation Policy, Documentation, Qualification, Process validation, Validation Approaches, etc
• Specific Guidance for APIs Manufactured by Cell Culture/Fermentation

Who should Attend

• Quality Assurance Associate/Specialist
• Quality management (VP of QA, QA/QC Manager, QA Director)
• Quality Auditors
• Regulatory Affairs Management (VP and/or Director and/or Manager of RA)
• Compliance Professionals
• Production Personnel (Production Specialists, Production Manager,Supervisor)
• Quality Engineering Manager
• Quality Engineer
• Validation Specialist
• Validation Engineer
• Manager of Validation Department