2023-09-12T05:14:19
5. Sanitation:
Availability of written specifications and procedures for cleaning the manufacturing areas and equipment.
6. Production:
(i) brief description of production operations using, wherever
possible, flow sheets and charts specifying important parameters;
(ii) arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage;
(iii) arrangements for reprocessing or rework;
(iv) arrangements for the handling of rejected materials and products;
(v) brief description of general policy for process validation;
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