Assessment

Assessment of product documentation

Missionpharma only accepts products that are sufficiently documented, and we perform product documentation assessment with focus on:

		The raw material
		The finished product

In our raw material assessment we evaluate the quality of the active pharmaceutical ingredients (API) and the inactive ingredients to ensure that raw materials of pharmacopoeia reference are used.

Our assessment of the finished product includes an evaluation of performed stability studies, monography, actual release criteria, bioavailability studies as well as the manufacturer’s experience with the particular product.

When needed, supplementary studies and controls are performed by the manufacturer on our request to complete the documentation of a product.

However, the product assessment can not stand alone, as the quality of the product highly depends on the actual manufacturing site, the individual production environment, laboratory tests and facilities, in-process controls and release criteria of the particular product.

Therefore, we perform on-site audit with the relevant product as a starting point but with a specific focus on the manufacturing facilities.

Assessment of site documentation

Very often a manufacturer has several different production sites that do not necessarily follow the same standards in terms of quality. Therefore we focus on the actual production facilities used to manufacture our products.

In addition, we always look at the manufacturer’s entire range of facilities as products can influence each other inadvertently. As an example, the production of penicillin products must always be separated from the production of other products due to the very high risk of cross-contamination, which can cause serious incidents of resistance and allergic reactions.

The assessment of the manufacturing site documentation is performed by our inspection pharmacists and includes an evaluation of the content in the Site Master File as well as certificates, licences and completed manufacturer questionnaire. We also focus on flow of the production, ground plans, technical drawings as well as water systems and ventilation.

Manufacturers that are able to document that their manufacturing site complies with our standards move on to the next step in the approval process. Quite a few manufacturers are not able to fulfil these requirements and are immediately rejected.

If the documentation is accepted by our QA team, it is further verified during on-site audit at the manufacturing site.