PRODUCT AND PROCESS VALIDATION. 13 ------------------------------ 11.1 Process............................................... 13 11.2
PRODUCT AND PROCESS VALIDATION. Process - C*P is responsible for ensuring that the manufacturing process is validated. The validation should ensure that the process is capable of consistently achieving the PRODUCTS acceptance specification.
PRODUCT AND PROCESS VALIDATION. 11.1 Process Validation DSM is responsible for ensuring that the manufacturing process is validated. The validation should ensure, with a high degree of certainty, that the process is consistently capable of consistently achieving the Product’s acceptance criteria.
PRODUCT AND PROCESS VALIDATION. 12.1 Process Validation- XERIS is responsible for ensuring the PYRAMID Production process is validated. The validation should ensure the process is capable of effectively and reproducibly achieving the Product acceptance specifications and quality attributes. PYRAMID shall provide adequate resources to execute process validations as per mutually approved protocols. XERIS is responsible for development and validation of the manufacturing process including processing hold times, formulation and process parameters, and filter validations. The activities may be contracted to PYRAMID, and if so, terms shall be outlined in the Master Services Agreement or in the Project Plan.
12.1.1 PYRAMID will work in conjunction with XERIS to support their process validation or related studies. PYRAMID may perform these studies on behalf of XERIS. XERIS holds final responsibility for the study design and execution, results, and conclusions.
12.1.2 PYRAMID will provide XERIS with appropriate quality system, material, process, or product data to support Xeris’ continued process verification activities. PYRAMID may also collaborate with XERIS on process assessments as a means of evaluating process variability. PYRAMID performs routine reviews of quality system, manufacturing, calibration, and maintenance data as part of the [***] management review. Where appropriate, those data may be made available to XERIS for incorporation into their process verification activities.
12.2 Cleaning Verification/Validation - PYRAMID is responsible for ensuring adequate cleaning of Product contact parts used in the Production of Product is carried out between Batches of different product to prevent contamination. Document No: Revision: Revision Date: Replaces: Page: QA-Xeris 00 11/10/16 NA Page 26 of 52
12.3 Sterilization and Depyrogenation Validation - PYRAMID is responsible for ensuring sterilization processes are validated and adequate sterilization and depyrogenation is carried out on the Components and appropriate equipment prior to the Production of each Batch of Products.
12.4 Equipment, Computerized Systems, Facility, and Utilities Qualification - PYRAMID is responsible for ensuring any equipment, computer, Facility, utility and support systems used for the Production of Product are qualified according to applicable regulatory requirements.
12.5 Laboratory Qualification - PYRAMID is responsible for ensuring all laboratories are in compliance with cGMPs and are qualified in all of the meth...
PRODUCT AND PROCESS VALIDATION. 11.1 Process - C*P is responsible for ensuring that the manufacturing process is validated. The validation should ensure that the process is capable of consistently achieving the PRODUCTS acceptance specification.
11.2 Cleaning Validation - C*P is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. ORPHAN will provide information (i.e. LD50, toxicity, solubility, batch 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 batches are made.
11.3 Equipment, Computer, Facility, and Utilities Qualification — C*P is responsible for all equipment, computer, facility, and utility qualification activities associated with the PRODUCTS.
11.4 Laboratory Qualification - C*P is responsible for ensuring that all laboratories are in compliance with applicable GMP guidelines. If analytical work is performed at C*P, then ORPHAN will also provide any existing analytical documentation to assist in methods transfer or methods validation. In addition, if analytical work is not performed at the Greenville site, C*P may elect to perform an audit on vendors to be used for analytical testing appropriate to manufacture of the PRODUCTS.
PRODUCT AND PROCESS VALIDATION. Process Validation ORPHAN is responsible for ensuring that the manufacturing process is validated. The validation should ensure that the process is capable of consistently achieving the Product acceptance specifications. ORPHAN will submit to CELLTECH copies of the Process Validation Reports as required by CELLTECH.
PRODUCT AND PROCESS VALIDATION. 11.1 Process Validation—IDEC and BAXTER are responsible for ensuring that the manufacturing process is validated. BAXTER is responsible for ensuring that the facilities, utilities and support systems are validated. The validation should ensure that the process is capable of consistently achieving the PRODUCT acceptance specification. BAXTER shall provide adequate resources to execute process validations as per mutually approved protocols.
PRODUCT AND PROCESS VALIDATION. 11.1 Process - C*P is responsible for ensuring that the manufacturing process is validated. The validation should ensure that the process is capable of consistently achieving the PRODUCTS acceptance specification.
11.2 Cleaning Validation - C*P is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. ORPHAN will provide information (i.
PRODUCT AND PROCESS VALIDATION. 11.1 Process New River is responsible for ensuring that the process for Manufacture is validated. The validation should ensure that the process is capable of consistently achieving the Product’s acceptance Specifications. Patheon will generate, internally approve and execute approved validation protocol(s) and may not use any validation protocol or issue a report unless New River technical personnel and New River Quality Assurance have first approved. Patheon will provide all protocols and reports in a timely manner to allow sufficient tune for review, prior to process requirements. New River will review all protocols and validation reports promptly, but [***] of receipt.
PRODUCT AND PROCESS VALIDATION. In this phase, clearly-defined procedures are agreed with the customer, to, demonstrate that the proposed processes are able to manufacture the product in a controlled and capable manner.
