Program Overview
This certification program provides regulatory professionals, quality assurance personnel, manufacturing staff, and compliance specialists with comprehensive knowledge of the World Health Organization (WHO) Good Manufacturing Practices (GMP) requirements. The program covers the main principles of GMP for pharmaceutical products, along with specialized guidance for biological products, sterile pharmaceutical products, herbal medicines, radiopharmaceutical products, solid dosage forms, and liquid and semisolid dosage forms. Participants will learn the regulatory framework, quality system requirements, premises and equipment standards, personnel qualifications, sanitation programs, raw material testing, manufacturing controls, quality control responsibilities, packaging and labelling controls, finished product testing, record keeping, validation, stability programs, and product-specific requirements.
Program Scope
This program encompasses the complete WHO GMP framework governing pharmaceutical products. Topics include:
- Regulatory foundation and Pharmaceutical Quality System
- Quality risk management and product quality review
- Premises design, construction, and contamination prevention
- Equipment qualification, calibration, and maintenance
- Personnel qualifications, training, hygiene, and clothing
- Sanitation programmes and cleaning validation
- Qualification and validation (DQ, IQ, OQ, PQ)
- Materials management including starting materials, packaging, and finished products
- Documentation, specifications, master formulae, and batch records
- Production operations and cross-contamination prevention
- Quality control, sampling, testing, and batch record review
- Complaints, product recalls, and self-inspection
- Contract production and analysis
- Sterile products: contamination control strategy, barrier technologies, aseptic processing
- Biological products: seed lots, cell banks, containment
- Herbal medicines: starting materials, specifications, quality control
- Radiopharmaceutical products: quality management, production, quality control
- Solid dosage forms: tablet and capsule manufacturing, granulation, compression, coating
- Liquid and semisolid dosage forms: solutions, suspensions, emulsions, ointments, creams
- HVAC systems: design, qualification, maintenance
Program Objectives
Upon completion, participants will be able to:
- Explain the legal and regulatory basis for WHO GMP and its application to pharmaceutical products
- Implement a Pharmaceutical Quality System incorporating GMP and quality risk management
- Design and maintain premises and equipment to prevent contamination and ensure clean, sanitary operations
- Ensure personnel are qualified, trained, and follow proper hygiene and clothing requirements
- Develop and implement sanitation programmes including cleaning validation and environmental monitoring
- Establish raw material testing specifications and vendor qualification programmes
- Control manufacturing operations through master formulae, batch records, and process validation
- Maintain an independent Quality Control function with authority to approve or reject materials and products
- Test packaging materials and control labels to prevent mix-ups
- Conduct finished product testing and issue certificates of analysis
- Manage records with data integrity principles and meet retention requirements
- Establish stability programmes to determine shelf life and monitor ongoing stability
- Implement complaint handling and product recall systems
- Apply specific GMP requirements for sterile products, biological products, herbal medicines, radiopharmaceuticals, solid dosage forms, and liquid and semisolid dosage forms
- Design, qualify, and maintain HVAC systems for non-sterile dosage forms
Target Audience
This program is designed for professionals who work in or support the pharmaceutical manufacturing industry globally:
- Quality Assurance Personnel
- Quality Control Personnel (analysts, supervisors, managers)
- Manufacturing Personnel (production, packaging, labelling)
- Regulatory Affairs Professionals
- Validation Specialists
- Compliance Officers
- Internal and External Auditors
- Importers, Distributors, and Wholesalers
- Contract Manufacturing Organizations
- Consultants to the pharmaceutical industry
- National Regulatory Authority personnel
Certificate Details
Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.
