PROCESS CONTROLS. 2.1 Distributor shall be responsible for supplier appropriate process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control and facility contamination control.
2.2 Company shall provide evidence that packaging containers maintain the integrity, quality, function, and sterility of the product for the entire shelf life, and not produce toxic residues during storage. Packaging must prevent or indicate the occurrence of tampering.
PROCESS CONTROLS. Will have the primary responsibility to FORMULATE and PACKAGE the PRODUCT in accordance with cGMPs, the master production records, PRODUCT SPECIFICATIONS, CMC DATA, and the NDA. X
PROCESS CONTROLS. 3.1 Both parties shall be responsible for all process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control, contamination control, complaint handling and trending and process validations, as required by Title 21 of United States Code of Federal Regulations, and other applicable regulations, and governmental laws.
3.2 Both parties shall maintain appropriate documented procedures.
3.3 Company shall provide evidence that packaging containers maintain the integrity, quality, function, and sterility of the product for the entire shelf life, and not produce toxic residues during storage. Packaging must prevent or indicate the occurrence of tampering.
PROCESS CONTROLS. 7.1 RTI shall maintain appropriate documented procedures.
PROCESS CONTROLS. 3.1 Both parties shall be responsible for all process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control, contamination control, [*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION. complaint handling and trending and process validations, as required by Title 21 of United States Code of Federal Regulations, and other applicable regulations, and governmental laws.
3.2 Both parties shall maintain appropriate documented procedures.
3.3 Company shall provide evidence that packaging containers maintain the integrity, quality, function, and sterility of the product for the entire shelf life, and not produce toxic residues during storage. Packaging must prevent or indicate the occurrence of tampering.
PROCESS CONTROLS. Describe in general terms how the project development process will be controlled to achieve the objectives of the project. Identify controls used to ensure all work, services, and products meet project standards and requirements. Identify state-of-the-art equipment to be utilized. Project specific controls will be identified in the project specific quality control plan.
PROCESS CONTROLS. Process monitoring and control operations will be performed by a computer based Control System. The Control System will coordinate CCC, boiler, pollution control, WTS, RRS and turbine generator and some auxiliary systems, all which be identified, defined and designed during the engineering phase. The Control System will be installed in either an administrative office or in the control room. Its major components will include necessary Input/Output Devices and an Operator Workstation. The Input/Output devices interface with required field input and output signals to provide data acquisition and stand along integrated control of the plant process. The Operator Workstation will provide an interface to the Control System for monitoring and controlling process operations. The operator Workstation will include a printer/logger and one operator console high resolution monitor, active graphic display, mouse and keyboard. The Control System will employ redundant processors and standby power supply to provide reliability and to minimize the effect of any single failure of the process control on process monitoring operations. These redundant devices shall be an integral part of the Control System. Upon detection of a failure in the primary device, the redundant device automatically will take over the required operation. If required, a separate centralized control panel will be provided for special instrumentation requirements and for specialized instrumentation whose function cannot be implemented in the computer based Control System. Hose stations and automatic sprinklers will be installed for fire control and suppression. Additional hose stations will be located in the process equipment area, as required. Additionally, portable fire extinguishers will be located adjacent to each hose rack and in other areas as directed by local fire codes and safety practices and insurance requirements. Safety procedures will be established by the plant manager and the chief engineer in accordance with industry standards. Together with design engineers, safety discussions and directives will provide the necessary guidelines for operating and maintenance personnel for specific equipment. Guidelines for plant safety standards and procedures will be based on labor and industry standards and the Federal Occupational Safety and Health Act (OSHA). Period safety meetings will be established and conducted by the plant manager and on-site engineering staff to keep employees abreast of any ch...
PROCESS CONTROLS. 2.1 Distributor shall be responsible for supplier appropriate process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control and facility contamination control.
2.2 Company shall provide evidence that packaging containers maintain the integrity, quality, function, and sterility of the product for the entire shelf life, and not produce toxic residues during storage. Packaging must prevent or indicate the occurrence of tampering. [*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.
PROCESS CONTROLS. 3.1 Both parties shall be responsible for all process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control, contamination control, complaint handling and trending and process validations, as required by Title 21 of United States Code of Federal Regulations, and other applicable regulations, and governmental laws.
3.2 Both parties shall maintain appropriate documented procedures. [*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.
3.3 Company shall provide evidence that packaging containers maintain the integrity, quality, function, and sterility of the product for the entire shelf life, and not produce toxic residues during storage. Packaging must prevent or indicate the occurrence of tampering.
PROCESS CONTROLS. 3.1 Both parties shall be responsible for all process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control, contamination control, complaint handling and trending and process validations, as required by Title 21 of United States Code of Federal Regulations, and other applicable regulations, and governmental laws.
3.2 Both parties shall maintain appropriate documented procedures.
3.3 Company shall provide evidence that packaging containers maintain the integrity, quality, function, and sterility of the product for the entire shelf life, and not produce toxic residues during storage. Packaging must prevent or indicate the occurrence of tampering. [*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.
