Language: English

The audit preparation, process, questionnaire and check list included in this Master Thesis is a proposal for auditing the manufacturing of chemical sterile active pharmaceutical ingredients which are manufactured for the European market.

The manufacturing of the above-mentioned APIs is usually carried out in two processes: a non-sterile process and a sterile process. The first step/stage of the sterile process is normally sterile filtration. Therefore this audit check list is in accordance with both “Volume 4 Part II Basic Requirements for Active Substances used as Starting Materials” and the “Annex 1 Manufacture of Sterile Medicinal Products”.

This audit check list can be used by the manufacturer of the sterile chemical active pharmaceutical ingredient as well as by the manufacturer of the sterile chemical pharmaceutical finished product in the sterilisation process of the chemical active pharmaceutical ingredients.

This audit check list can be used by the pharmaceutical manufacturers as well as by the agents, brokers and traders. This audit check list is not suitable for either the inspection of a competent authority or an inspection relating to an approval of a pharmaceutical product.

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