Requirements should be submitted for each lot delivered for testing
The submitted product batch folder should contain the following documents:
- CAPA request form for sample analysis.
- Cold chain assurance report from CAPA.
- Batch release certificate from the National Regulatory Authority (NRA) of the country of origin for the imported products.
- Manufacturer certificate of analysis for the finished product.
Manufacturer certificate of analysis for the solvent (if present).
- Complete summary protocol for each batch according to the international guidelines (for of vaccines and plasma derivatives only).
- Plasma release certificate from the National Regulatory Authority (NRA) of the country of origin for the imported products (for plasma derivatives only).
- In case that human albumin is used as a stabilizer, the company is committed to provide the following additional documents:
a) Human albumin batch release certificate from NRA of country of origin.
b) The document that proves the use of the same human albumin batch for which a release certificate is submitted in the manufacture of the final product of the batch in release request.
Sufficient number of samples & testing requirements ( reference material,……. for each lot for laboratory testing)