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 β 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.
Appears in 1 contract
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 POZEN 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 β - 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 guidelinescGMP's and are qualified in all of the methodology associated with the PRODUCTS. If analytical work is performed at C*P, C*P then ORPHAN the POZEN 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 PRODUCTStesting.
Appears in 1 contract
Sources: Supply Agreement (Pozen Inc /Nc)