VACCINES FOR HUMAN USE—GENERAL CONSIDERATIONS——USP
VACCINES FOR HUMAN USE—GENERAL CONSIDERATIONS
Acceptance criteria: The product specifications and acceptance or rejection criteria, with an associated sampling plan,
necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).
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Adjuvant: A component added to a vaccine which, although not pharmacologically active in its own right, enhances or
modifies the patient’s response to the vaccine immunogens.▲ (USP 1-May-2021)
Adventitious agent: A microorganism (e.g., bacteria, fungi, mycoplasma, spiroplasma, mycobacteria, rickettsia, viruses,
protozoa, parasites, TSE agent) that is inadvertently introduced into the production of a biological product.
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Ancillary raw material: Ancillary raw materials are components or reagents used during the manufacture of vaccines
and biologicals that exert an effect on the product but are not intended to be part of the final product.▲ (USP 1-May-2021)
Batch: A specific quantity of a drug or other material intended to have uniform character and quality, within specified limits,
and produced according to a single manufacturing order during the same cycle of manufacture.
Biological product: Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention,
treatment or cure of diseases or injuries of man.
