Process Validation

The purpose of process validation is to document, based on studies and statistical methods, that the medicinal product manufacturing process of GMP production works as planned and that the requirements set for the product are achieved reproducibly.

Process validation is applied especially to aseptic pharmaceutical manufacturing and cytostatic pharmaceutical manufacturing, where process accuracy and compliance are critical to the safety and quality of the final product.

Process validation is based on the EU GMP, Annex 15, Validation requirement, and is performed based on an approved validation plan.

Cleanrooms, commodities, systems and production equipment related to the medicinal product manufacturing process must be approved and validated before process validation.

We offer our clients support in the planning and implementation of process validation. If necessary, we prepare and get approval for the validation plan, prepare a validation protocol and participate in validation reporting. The client’s personnel carry out the manufacturing of medicinal products themselves.

If necessary, we perform measurements during operation and microbiological sampling (In Operation) as part of process validation.

Please feel free to contact us if you have any questions about process validations.