GMP: where do we come from - where do we go to?
- Development of GMPs
- GMP: Goal and general ideas
- Types of regulatory documents and their meaning
- GMP regulation for APIs, medicinal products and excipients - a comparison
- Authorities and industry groups: ICH, PIC/S, EMEA, FDA, WHO, APIC, ISPE, IPEC
GMP in the US
- Comparison of US and EU regulations
- Differences between European and FDA view on GMP / GMP vs cGMP
- Typical expectations of FDA and European inspectors
Quality Management System
- Quality Management System cited in the regulations
- General aspects of Quality Assurance
- How to implement and structure a system
- Responsibilities
Personnel and Training
- General aspects
- Qualification
- Key personnel
- Job descriptions
- Training (purpose, goals, contents, target groups)
- Planning and documentation of training
Hygiene / Personal Hygiene
- General aspects and rules
- Hygiene program
- Personnel flow
- Medical examination
- Contamination
- Monitoring
Documentation
- Structure of documentation
- Responsibilities for the documentation
- SOP
- Documentation in the manufacturing process
- Documentation in the quality control
- Batch record review
- Annual report / Product quality report
- Specifications
Specific aspects of a QA System
- Deviations
- CAPA
- Change Control
- OOS
- Failure Investigations
- Self-inspections
Risk Management
- Main topics of ICH Q 9 / Part 3 EU GMP Guideline
- Risk management tools
- Use of risk analysis during qualification
- How to handle FMEA?
Premises / Production
- Requirements for room and equipment
- Classification of rooms
- Sterile production/isolator
- Maintenance of hygiene
- How to behave during production
Qualification/Calibration/Maintenance
- Definitions: Qualification, validation, calibration, maintenance, risk analysis
- Organizing qualification and validation: the validation master plan (VMP)
- Steps in Qualification studies: DQ, IQ, OQ, PQ
- Qualification parameters of typical types of equipment: Clean rooms, water systems, production equipment, analytical equipment
- Performing risk analysis: tools and practical tips
- Calibration: critical types of equipment
- How to build up a calibration system
- Maintenance: Requirements and system
- Validation of computerised systems
Process Validation, Computer Validation and Validation of Analytical Methods
- General aspects and requirements
- Process Validation
- Documentation of process validation
- Validation of analytical methods
- Documentation of analytical methods validation
Cleaning Validation
- Regulators requirements
- The cleaning procedure
- Building up a cleaning validation
- Sampling
- Analytical tests
Audits and Inspections
- Types of audits
- Requirements
- Dos and don’ts for the auditee - How to survive audits?
- Performing audits and self-inspections
- Good audit practices
Packaging/Storage/Transportation
- Packaging/Storage/Transportation in the regulations
- Managing of packaging process
- What is necessary to regulate in a pharmaceutical company
- WHO good storage practice – elements and requirements
- Transportation as part of storage
- How to maintain the quality during transportation
Falsified Products
- Regulatory requirements
- Responsibilities of QP and the pharmaceutical industry
- What measurements can be taken
- Strategies against falsified products