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|English to French translations [PRO]|
|English term or phrase: charge-in of components|
|-Control of Components and Drug Product Containers and Closures|
-Receipt and storage, testing and approval or rejection,
- Production and Process Controls:
Written procedures, deviations, charge-in of
components, calculation of yield, equipment
identification, sampling and testing, time limitations,
control of microbiological contamination, reprocessing
|assurance qualité pour l'identification, la pureté et le dosage de constituants|
la qualité des médicaments et d'assurance qualité, afin qu'ils ... botanique et contrôle physico-chimique (identification et dosage de constituants à effet ...
Etude expérimentale ; Chromatographie couche mince ; Analyse quantitative ; Densitométrie ; Contrôle pureté ; Assurance qualité ; Médicament ; Evaluation ...
Charge-in of components.
Written production and control procedures shall include the following,
which are designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess:
(1) The component was released by
the quality control unit;
(2) The weight or measure is correct
as stated in the batch production
(3) The containers are properly iden-
(d) Each component shall be added to
the batch by one person and verified by
a second person.
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