In the series of articles "Basic Principles of Effective and Efficient Qualification" in pharmind by Ralf Gengenbach, Part 2 has now been published: "Planning is what counts".
The 4-part series further examines the known problems of qualification in the pharmaceuticals industry and offers proposed solutions for especially critical points. The focus is on "HOW".
The second part deals with the planning of qualification and validation projects. Structured, formalistic and documented procedures ultimately guarantee a high level of quality for technology, processes and the product. At the same time, the concepts introduced must be highly flexible in order to be equally usable and efficient for complex projects such as new construction or reconstruction and for simpler procedures such as re-qualification or the procurement of a single device.
This article is dedicated to exactly such concepts, the planning and the essential elements at the beginning of each validation project. Starting from the content, the document is only then viewed.
Individual subject areas are validation concept, validation team, master planning, user requirements, risk analysis, traceability and finally the whole package. Numerous practical tips and clear overviews make this contribution a valuable guideline for successful planning.
The publication is available for download in German language under www.gempex.com/GMP Knowledge.
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This publication series is to be concluded in 2020. Part 3 deals with implementation and part 4 is about comparison with the regulations.