"Here we go: the implementation" - in the series of articles "Basic Principles of Effective and Efficient Qualification" by Ralf Gengenbach in pharmind part 3 has been published.
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 now published part 3 deals with the EPC phase: Engineering, Procurement, Construction. Many other project partners now in the implementation come into play - manufacturers, suppliers, assembly companies. This is where it proves how good a developed qualification concept is, how easy or difficult it is to integrate suppliers and their input. Now GEP (Good Engineering Practice) meets GMP (Good Manufacturing Practice) and the topic of "integrated qualification", the combination of normal engineering activities with qualification activities, could come to full fruition. What needs to be taken into account here?
The article gives numerous suggestions, shows example forms and checklists. Topics are selection and involvement of the parties involved in the project, necessary quality systems and agreements, targeted use of technical tests (FAT, SAT), typical qualification activities in connection with DQ, IQ, OQ and PQ and briefly highlights fast-track projects. Keywords are supplier qualification, cooperation on the construction site, project and quality plan, design review, pre-commissioning, tests, checklists and forms.
Look forward to a valuable reading!
The publication (German language) can be requested under www.gempex.com/GMP Knowledge.
You may contact the author directly: Ralf.Gengenbach@gempex.com
Part 4 "Alignment with the rules and regulations" will be published in pharmind 11-2020 in November, thus completing the series of articles on effective and efficient qualification.