I am trying to preparation stability protocol ? can i have template for this protocol ?
Go forward with ICH guidlines and also follow one book i.e Stability testing by P.P Sharma ji
Protocol contents
- Objective:
- Scope:
- Responsibility
- Storage conditions
- Pack details
- Specifications to be followed
- Sampling plan
- Acceptance criteria
- Significant change
- Enclosures
- Abbreviation
- Revision history
With this u can elaborate.