Lot Release

Requirements should be submitted for each lot delivered for testing

The submitted product batch folder should contain the following documents:

  1. CAPA request form for sample analysis.
  2. Cold chain assurance report from CAPA.
  3. Batch release certificate from the National Regulatory Authority (NRA) of the country of origin for the imported products.
  4. Manufacturer certificate of analysis for the finished product.
    Manufacturer certificate of analysis for the solvent (if present).
  5. Complete summary protocol for each batch according to the international guidelines (for of vaccines and plasma derivatives only).
  6. Plasma release certificate from the National Regulatory Authority (NRA) of the country of origin for the imported products (for plasma derivatives only).
  7. 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)

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