Qualification and validation are elementary components of a quality assurance system to achieve compliance. They prove that the rooms, equipment and procedures/processes used for manufacturing and quality control are suitable for your purposes. They also ensure that the manufactured medicinal products or active pharmaceutical ingredients are of the required quality.
Validation is the demonstration that processes, methods, equipment, materials, operations or systems actually produce the expected results in accordance with the principles of good manufacturing practice (EU GMP guidelines). Expert knowledge and many years of experience are required in order to design the validation in the best possible way. Process-oriented and risk-based approaches enable you to achieve cost-optimized solutions while fully complying with the requirements from a GxP compliance perspective. Simple validation concepts compliant with the current Annex 1 (2022) incl. contamination control strategy (CCS).
