Division 3.2.2.3 Manufacturing process of the finished medicinal productF1
United Kingdom
- a))
The description of the manufacturing method accompanying the application for Marketing Authorisation pursuant to Article 8 (3) (d), shall be drafted in such a way as to give an adequate synopsis of the nature of the operations employed.
For this purpose it shall include at least:
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mention of the various stages of manufacture including process controls and corresponding acceptance criteria, so that an assessment can be made of whether the processes employed in producing the pharmaceutical form might have produced an adverse change in the constituents,
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in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity of the finished product,
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experimental studies validating the manufacturing process, where a non-standard method of manufacture is used or where it is critical for the product,
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for sterile medicinal products, details of the sterilisation processes and/or aseptic procedures used,
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a detailed batch formula.
The name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing shall be provided.
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- b))
Particulars relating to the product control tests that may be carried out at an intermediate stage of the manufacturing process, with a view to ensuring the consistency of the production process shall be included.
These tests are essential for checking the conformity of the medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active substances (or of all the excipient constituents subject to the same requirements as the active substances).
The same applies where the quality control of the finished product depends on in-process control tests, particularly if the medicinal product is essentially defined by its method of preparation.
- c))
Description, documentation, and results of the validation studies for critical steps or critical assays used in the manufacturing process shall be provided.