Prozeßvalidierung in der Wirkstoffsynthese
Norbert Skuballa Schering AG, PQ Qualitätsmanagement, Berlin Process Validation in API Synthesis Within all international GMP regulations special emphasis is laid on the importance of process validation in the synthesis of active pharmaceutical ingredients (APIs).
There is a common understanding regarding the objective of process validation: evidence is to be provided that a process can be performed reproducibly by means of defined batches.
In addition to ensuring compliance with GMP requirements there is no doubt that a well performed process validation provides a number of benefits for the API manufacturer such as, for example, assuring the quality of the API as well as avoiding complaints and rejects.
The following article deals with the question of how the above mentioned goals within API manufacturing can be achieved. In this context the following frequently occuring key points are discussed:
How are critical process parameters and steps which are to be validated identified (quality risk analysis)?
How should test batches be dealt with, which were produced on production equipment prior to validation?
What is the main content of a master validation plan for API synthesis?
What are the key points of a validation plan for each synthesis step to be validated?
Should the upper and lower limits of the ranges of critical parameters be challenged during production?
How is the validation assessed, especially with regard to deviations which have occurred during validation? Key Words Entwicklungsbericht · Prozeßvalidierung · Validierungsbericht · Validierungspflichtige Synthesestufen · Validierungsplan · Wirkstoffherstellung | 
