Cleaning Verification/Validation Clause Samples
The Cleaning Verification/Validation clause establishes requirements for confirming that cleaning processes meet specified standards or regulatory requirements. Typically, this involves documented procedures for testing and inspecting equipment, surfaces, or environments after cleaning to ensure the removal of contaminants or residues. This clause is essential for industries such as pharmaceuticals, food production, or healthcare, where inadequate cleaning can lead to safety risks or regulatory non-compliance. Its core function is to ensure product safety and regulatory adherence by providing a systematic approach to verifying the effectiveness of cleaning activities.
Cleaning Verification/Validation. LONZA is responsible for ensuring that adequate cleaning is carried out between lots of different product to prevent contamination. Data should be available to support the campaign of lots of the same product and the type of cleaning that will be performed in between manufacturing of the same product. ORPHAN will provide information (i.e. LD50, toxicity, solubility, lot size, fill volume, product min dose/70Kg patient) to establish cleaning limits. The cleaning procedure and analytical methodology will be reviewed before the first product lots are made.
Cleaning Verification/Validation. ▇▇▇▇▇▇ is responsible for ensuring that adequate cleaning of product contact parts used in the manufacture of Product is carried out between batches of different product to prevent contamination. Halozyme will provide information (i.e. LD50, toxicity, solubility, batch size, fill volume, product max human dose (MHD) for the Initial Drug (as defined in the Development and Supply Agreement), to establish cleaning limits. Until such time as the cleaning procedure and analytical methodology is validated for the Initial Drug, Halozyme will purchase new product contact equipment; including but not limited to, glass receiving vessels and filling needles, to be used in the manufacture of all Product batches.
Cleaning Verification/Validation. 7.3.1 Avecia is responsible for ensuring that adequate cleaning verification of product contact parts used in the manufacture of Stressgen QA API is carried out between batches of different products to prevent cross-contamination.
7.3.2 Stressgen QA will provide information (solubility, toxicity, dose etc.) to establish cleaning limits.