Procedure for assessing the acceptability, in principle, of vaccines ...

For recombinant vaccines, a description of the construction and characterization of the
recombinant vector, as well as source of master cell bank/constructs, shall be provided.
Include details of the manufacture and quality control of any adjuvant and diluents.
5.3 Describe the general policy for process validation. List process validation
activities performed.
5.4 Summarize arrangements for the handling of starting materials, packaging
materials, bulk and finished products, including sampling, quarantine, release and
storage.
5.5 Summarize arrangements for the handling of rejected materials and products, and
procedures for their destruction.
Chapter 6: Quality control
6.1 Starting materials
6.1.1 List control tests performed on raw materials, with appropriate characterization
of starting materials, namely:
− list of raw materials meeting compendia specifications, indicating the
pharmacopoeia;
− list of raw materials meeting in-house specifications, including the tests
performed and specifications;
− list of biological starting materials (human or animal origin) with
information on the requirements to avoid risk of transmissible spongiform
encephalopathies and human diseases (HIV, hepatitis, etc) in the final
product;
− list of media with ingredients, tests performed and specifications.
6.1.2 List control tests performed on labelling and packaging material(s), including
primary and secondary packaging material.
6.1.3 Describe qualification criteria for suppliers of raw material and relevant
certificates.
6.2 Intermediate products (as appropriate)
6.2.1 List routine tests performed and specifications for intermediates. Include copies
of standard operating procedures for critical quality control tests (uncontrolled copies
or concise descriptions of the method and retest criteria are acceptable).
6.2.2 List assay validation activities performed.
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