translate English to French: Test Product Manufacturer of Reference Product Lot Number Batch Size of test product Expiry Date 4. For all products: a) the complete quantitative formulation of the product b) specifications with limits and a description of the analytical methods for the medicinal ingredients (refer to pharmacopoeial standards where applicable) c) specifications with limits and a description of the analytical methods for the finished product (refer to pharmacopoeial standards where applicable) d) Certificate of Analysis for one lot of the finished product pharmacodynamic/clinical study, if applicable) e) the name and address of the fabricator of the medicinal ingredients f) the name and address of the fabricator (and importer, if applicable) of the product g) the Master Formula for a typical batch and a detailed method of manufacture including where applicable all steps critical in assuring the sterility of the product (e.g. filling and sterilization procedures, sterilization of packaging components, and in-process controls) h) certification that the lot used to demonstrate equivalence was manufactured using the identical formulation as, and using a method equivalent to (i.e. same process, equipment design and operating principles), that described above in (g)).
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