Cleaning Validation Clause Samples

Cleaning Validation. Fresenius is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. The cleaning process will be validated before the first PRODUCT Batches are made for TransMedics. TransMedics shall review the cleaning validation on an audit basis. Data should be available to support the campaign of batches of the same product, and the type of cleaning that will be performed in between manufacturing of the same product.

Cleaning Validation. 13 11.3 Equipment, Computer, Facility and Utilities Qualification......................................... 13 11.4

Cleaning Validation. DSM is responsible for ensuring that adequate cleaning is carried out between lots of different products 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. Barrier will provide information (i.e. LD50, toxicity, solubility, lot size, fill volume, product min dose/70Kg patient) and establish cleaning limits with DSM assistance.

Cleaning Validation. BIRI is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. BIRI is responsible for having approved cleaning procedures for Product(s)

Cleaning Validation. 11.2.1 Patheon is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. This is achieved and verified with the overall cleaning validation program on site. 11.2.2 New River will provide available information to establish cleaning limits for New River Product(s) within 7 business days of the request- The cleaning procedure and analytical methodology may be reviewed by New River upon request. 11.2.3 Patheon is responsible for having appropriate cleaning procedures for all products manufactured on non-dedicated equipment used to Manufacture New River Product(s). 11.2.4 Patheon is responsible for having appropriate cleaning procedures for New River product(s) manufactured on dedicated equipment. The cleaning procedure and analytical methodology must be reviewed and approved by New River prior to use by Patheon. 11.3 Equipment, Computer, Facility, and Utilities Qualification Patheon is responsible for the safe, compliant and efficient working of all equipment, computer, utility and facility qualification activities associated with the products, including maintenance. Patheon is also responsible for the validation and qualification of all equipment, computer, and utilities associated with the Products. As deemed appropriate, equipment shall be qualified prior to use by performing Installation Qualification, Operation Qualification and Performance Qualification (as applicable) using protocols in accordance with all applicable laws, rules and regulations. Should an issue become evident that has or could affect the Products, Patheon will notify New River [***]. Patheon must make available Equipment, Computer, Facility, and Utilities Qualification data during an Annual or Event MA.

Cleaning Validation. Cleaning procedures relating to a Product will be developed and validated by OSG. OSG shall notify ViroPharma in writing promptly following the approval of the validated cleaning process. OSG shall assure that equipment and facilities used in the Services and/or Manufacturing of the Product and also used for other client’s products, shall be cleaned in accordance with validated cleaning procedures for such products.

Cleaning Validation. Nastech is responsible for ensuring that adequate cleaning is carried out between lots of different products to prevent contamination. Data shall 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. A documented protocol to show that each cleaning validation was successful will be issued by Nastech. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

Cleaning Validation. 10.2.1 SYNCO is responsible for ensuring that cleaning processes are validated for all products produced in the SYNCO facilities and that adequate cleaning is carried out on components and equipment between batches to prevent contamination at SYNCO. Chiron is responsible for the validation of the cleaning processes related to Chiron's products. 10.2.2 CHIRON and SYNCO will cooperate to establish cleaning limits for the facilities involved in the manufacture of product. 10.2.3 The cleaning procedures and analytical methodology will be jointly reviewed. SYNCO and CHIRON will review cleaning procedures and testing methodology pertaining to product.

Cleaning Validation cleaning validation will be required throughout the process, including dedicated and non dedicated equipment i.e. general equipment, mixing and holding tanks, filling line. Specific cleaning method is available at Gentium and will be transferred. Batch Release – Subcontractor (QP) performs the batch release to Gentium, issuing Certificate of Analysis and Certificate of Compliance. The Batch Release to the market has to be performed by Gentium.