Pre-validation Activities Clause Samples
The Pre-validation Activities clause defines the preparatory steps and requirements that must be completed before formal validation processes begin in a project or contractual arrangement. This typically includes tasks such as documentation review, equipment calibration, personnel training, or initial system checks to ensure all necessary conditions are met for successful validation. By outlining these activities, the clause helps ensure that the validation phase proceeds smoothly and efficiently, reducing the risk of delays or failures due to incomplete preparation.
Pre-validation Activities. Objective: prepare validation campaigns · Deliverables: · Update Process development report — Compilation of the process knowledge (pre-qualification and qualification batch) · Master validation protocol · Upstream and Downstream process validation protocols · Cost: · Process development report upstream · Master validation protocol · Upstream process validation protocol · Process development report downstream · Downstream process validation protocol · Expected time needed: ± 20 working days (upstream and downstream activities in parallel).