Abstract

This contribution is part of a 4-part series of articles. Part 1 deals with basic principles, part 2 with planning, part 3 with implementation and part 4 is about comparison with the regulations.

After having clarified the basic principles and the basic understanding of terms in the first part, the topic of planning should be considered in this part 2. Validation including qualification is characterized by a strictly systematic, formalistic and documented, i.e. a planned procedure. Precisely these characteristics are one of the great strengths of this quality assurance measure. One does not want to forget or overlook anything, one wants the necessary testing and verification activities to be coordinated with experts, and one wants to have the last verifying check ensured by the binding and responsible signature. Only such an approach guarantees a high level of quality, for technology, processes and for the product.

Validation or qualification can be highly complex projects, when it comes to new construction or alteration measures or the introduction of new products and associated processes. Sometimes, however, it can also be a simple action, for example if only a single piece of equipment is purchased or only a re-qualification or re-validation is required. The introduced concepts must be correspondingly flexible without compromising the systematics and thus the quality of implementation.

The following article deals with these concepts, the planning and the essential elements that are at the beginning of each validation project. It is deliberately based on the content – what needs to be regulated, what needs to be described – and only then on the document. If the term validation is used, it is to be understood as an umbrella term for qualification and validation measures.

Ralf Gengenbach startete nach seiner universitären Ausbildung zum Chemieingenieur an der Technischen Universität (TU) Karlsruhe seine berufliche Laufbahn 1987 in der BASF AG, Ludwigshafen. Über 10 Jahre agierte er als interner Good-Manufacturing-Practice(GMP)-Berater, wobei er neben der Etablierung eines effizienten und kostenorientierten Qualifizierungssystems in zahlreichen Fachausschüssen zu diesem Thema u. a. beim Deutschen Institut für Normung (DIN), Verband der Chemischen Industrie (VCI) und der Gesellschaft für Chemische Technik und Biotechnologie (DECHEMA) mitwirkte. Er war früh in die Ausarbeitungen und