Lecture 4 Flashcards
DEFINITION GMP and cGMP
(cuurent) Good Manufacturing Practice:
Rules for the design and contriol of manufactering process to consistently and reliable meet the predefined requirements for process materials and final product
Must be followed during production, testing and handling
Application GMP
- Medicine, medical devices
- active ingredients
- cosmetics
- food (also animal)
History
1883 first efford for Food and Drug Act
1901&1937&1961: dead people
1968 WHO descrobes international ground rules for GMP
Key Points
- Traceability: completely for product and equipment
- Reproducibility: identical rules
- Variability: for materials, process and equipment
- Risk based decisions: NEW Process and equipment
Key Objectives
- Contamination prevention: can be caused by enviroment, people, equipment, process
- Identity and Purity: of Raw Materials, Active Pharmaceutical Ingrediant (API), packing mat
- Saftey
What about Quality and how is it influenced
Quality is the nature of a medical product as determined by its identity, content, purity, chemical/physical/bio properties or by the manufacturing process
influenced by: personnel, process, input, equipment
What do authorities want to see? And how is it ensured?
- API definition
- Definition of critical processes with risk assessment
- design (hygiene, fire, process, GMP codes)
- Verified drawings of buildings
- detailed layout of equipment, building, support areas
Pharmaceutical quality management systems (PQMS) ensures fulfillment
What are the three Stages?
- Process Design: defining commercial manufacturing process based on development and scale up
- Process Qualification: confirming that manufacturing process as designed is capable of reproducible commercial manufacturing
- continued Process Validation: during routine production -> process remains in stable control
