Sampling Plan- Sterile Injectibles


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.


The official test, the USP (Volume 30) recommends testing 40 units per production lot.
Please look Table attached

For combination products, the ISO 11137/111354 standards recommend various sterilization validation sampling plans based on lot size and validation method. In cases where small lots (>1000) are manufactured, the sampling size depends on lot size.

<img src=/uploads/db7093/original/1X/b7e2beb34cdd46bc5c6ab7a5e0443864753eb90d.jpg">

For retention purposes, it is not necessary to keep the full number of samples required in table of the European Pharmacopoeia sterility test monograph to “repeat” the sterility test performed for release purposes, but only a sufficient quantity to allow the carrying out, on two occasions, a confirmative test using the minimum quantities described in table of the monograph.

Thanks for your input Durga,