Planning phase – Preparing a method transfer
“Materials” that need to be handed over
- SOP(s) of the test instruction(s)
- Validation reports
- Product specifications
- Samples and reference standards that need to be used
Information that needs to be handed over and compiled
- Quality Agreement / technical contract
- Intended purpose of methods
- API, excipients, IPC, stability or product release
- Identification, testing for impurities, content (assay)
- Details about the product
- For example light sensitive, adsorption to plastic or else
- Details about the method performance (--> risk and gap assessment)
- Specific device / configuration necessary?
- Responsibilities
- Scheduling
- Transfer strategy