Through Pharmaceutical Procurement and Supplier Qualification the quality of the components and the compliance to GMP is ensured.
The procurement of raw materials, consumables, components and equipment is an important part of pharmaceutical and medical-technical production. It is essential to ensure the quality of those components and to meet the official GMP requirements (among other things EU GMP guidelines Part 1, Chapter 1 and 7 as well as Part 2).
Before a new line can finally be ordered, a User Requirements Specification (URS) has to be prepared by a delegated person or the validation coordinator of the system owner and submitted to selected suppliers. “The User Requirements Specification (URS) contains the set of owner, user and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system" as defined by Annex 15 of the EU GMP guide.
In response to the URS, the supplier prepares a Functional Design Specification (FDS) to demonstrate that all requested needs will be fulfilled, if they were chosen. Based on this information and the quotes, the supplier will be selected and qualified by the owner.
The supplier qualification can be carried out in different ways, whereby the scope of qualification depends on the categorization of the product to be procured. Examples are the sending of a questionnaire for self-disclosure, testing of material samples or an on-site audit (also realizable as a third party audit). Combinations are always possible.
If it is a long-term ordering process, the continuous fulfilment of the requirements can only be ensured by regular qualification of the supplier.
Are you planning a pharmaceutical procurement process or supplier qualification and have questions about it or need support due to lack of resources? Then call us at +49 69 153 293 709.
Valicare GmbH, a subsidiary of Syntegon Technology GmbH, has been supporting customers from the pharmaceutical and medical technology sector with accompanying GMP consulting and hands-on support since 2002. Our experienced engineers and GMP consultants qualify your plants and suppliers, validate your processes, methods and systems, carry out audits, train your staff and prepare GMP documentation for all areas.
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