Just wondering if anybody has any examples of sampling plans for process validation of sterile pharmaceutical injectable products or could share their thoughts on the following:
- Bracketing and Matrixing approach of products
- definining worst case for similiar products etc.
- where to sample and quantity of sampling to assure an accurate representation of batch and process reproduciblity is attained.
Any information on the approach for process validation of sterile injectables would be appreciated.