Competency information
Details
Correctly identify validation requirements for any changes to processes caused by the introduction of a new product.
Considerations
- Requirements of container, closure and component preparation and validation.
- Reviewing validation protocols.
- Microbiological validation recommendations to ensure sterility is maintained.
- Requirements of process validation.
- Requirements of product/container to allow sterilisation (e.g. aqueous fluid, heat-stable container).
- Requirements for robust stability data to support shelf life.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 | Outcome Apply the principles of EU Good Manufacturing Practice to develop a safe new product. |