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Today’s topic is related to “PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM”
Effective pharmaceutical quality system is to enhance the quality and availability of medicines around the world in the interest of public health
Implementation of Quality management system throughout the product lifecycle shall facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities
Quality management procedures applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology and biological products, throughout the product lifecycle
The product lifecycle includes the following technical activities for new and existing products:
Pharmaceutical Development
- Drug substance development
- Formulation development (including container/closure system)
- Manufacture of investigational products
- Delivery system development (where relevant)
- Manufacturing process development and scale-up
- Analytical method development
Technology Transfer
- New product transfers during development through manufacturing
- Transfers within or between manufacturing and testing sites for marketed products
Commercial Manufacturing
- Acquisition and control of materials
- Provision of facilities, utilities, and equipment
- Production (including packaging and labelling)
- Quality control and assurance
- Release
- Storage
- Distribution (excluding wholesaler activities)
Product Discontinuation
- Retention of documentation
- Sample retention
- Continued product assessment and reporting
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