Validation and Qualification Sample Clauses
The 'Validation and Qualification' clause establishes the requirements and procedures for ensuring that equipment, systems, or processes meet predefined standards and are fit for their intended use. Typically, this involves documented testing, inspections, and reviews to confirm that all components function correctly and consistently within specified parameters. By mandating these steps, the clause helps prevent operational failures and ensures compliance with regulatory or quality standards, thereby reducing risk and ensuring reliable performance.
Validation and Qualification. Formosa is responsible to ensure that all equipment, facilities, utilities and computer systems used for the production of the GMP steps of the API are qualified or validated in accordance with all applicable GMP regulations and guidance documents and are maintained in a validated state.
Validation and Qualification. (1) NPS and ▇▇▇▇▇▇ shall mutually agree in writing upon a validation and qualification documentation to ensure that any Product specific and quality related validation, such as process validation, packaging validation, analytical method validation, cleaning validation, and equipment qualification, is in accordance with GMP and the responsibilities set forth in APPENDIX 6 hereof.
(2) ▇▇▇▇▇▇ shall provide to NPS the Product quality related validation and qualification documents for review and approval.
(3) ▇▇▇▇▇▇ agrees that its suppliers of Materials, including packaging materials, substances, and excipients, shall be re-qualified as required by GMP. Therefore, ▇▇▇▇▇▇ shall, all in accordance with the Pharmacopeia, appoint an external laboratory or other qualified party with the testing of such Materials, substances, and excipients.
Validation and Qualification. In accordance with EDDI internal procedure the applicable equipment, analytical and control procedures (including cleaning procedures where applicable) shall be validated and/or qualified, as applicable, by EDDI for the facility intended for use for production of the Product Intermediate. EDDI is responsible for calibration and maintenance of equipment, automated system and facilities. EDDI will determine the scope of test methodology validation required, in accordance with internal EDDI procedures and applicable regulatory guidelines. For those procedures which appear in the current USP/NF or other recognized standard references, there shall be a statement indicating the reference. For those test methods developed by EDDI, documentation supporting the test method shall be provided to MAP QA, on-site at EDDI’s Facility. For test methods developed by MAP, MAP shall supply EDDI with the supporting documentation with retaining exclusive rights to MAP. For Phase III supplies, all validation protocols used for validating Product Intermediate processes (production and testing) and equipment shall be prepared by EDDI per EDDI internal procedures. Validation protocols for validating Product Intermediate processes shall be reviewed and approved by MAP QA and EDDI prior to implementation. A summary report of process validation for such Phase III supplies shall be provided to MAP and the approved validation protocol, related validation and qualification documents and final reports for such cGMP supplies shall be maintained by EDDI, including in its DMF as required by regulatory authorities. Use of Phase III supplies need to be determined prior to manufacturing to determine if validation is needed.
Validation and Qualification. New Products Only The process, manufacturing and control procedures (including cleaning procedures, hold times, mixing studies, sterilization, etc.) shall be validated and qualified by Laureate utilizing equipment and personnel in the facility intended for manufacture of new products for Cytogen, or changes to Product. This will be accomplished under a separate Agreement. For Validation of equipment or procedures requested by Cytogen, Laureate will draft a Validation Protocol containing all required activities, acceptance criteria and documentation and will submit the protocol to Cytogen for review and approval. The Validation Protocol will be executed on at least three (3) batches of new product or changes to Product, unless otherwise agreed upon between Cytogen and Laureate. Exceptions encountered during the execution of the Validation Protocol will be documented and communicated within 30 days to Cytogen. Exceptions that cannot be resolved may require the Validation Protocol to be repeated on additional batches until at least three (3) consecutive batches meet all specification requirements. Laureate must document any exceptions encountered during the execution of the Validation Protocol. All related validation/qualification documents would be assembled in a validation summary report and provided to Cytogen for review and approval. Laureate would retain the original of the approved protocol and final report. Additional test methods may be developed and/or portions of validation testing may be performed by Laureate and included in the Validation Protocol. These commitments shall be detailed in the Validation Protocol. All validation work performed by Laureate in support of any new Cytogen Product will be handled in a separate Supply Agreement. Any additional validation work performed by Laureate in support of the current Product will be handled in an amendment to the current supply agreement.
Validation and Qualification. 23.1 Certain Millennium Authorized Contractors, as required by GMP, shall have a written Validation Plan that will result in the ability to provide documented evidence that manufacturing processes will consistently deliver Product meeting predetermined quality specifications. All operations and systems that could influence product quality, safety or efficacy must be qualified or validated as a condition of use, as follows:
i. Qualification of facilities, utilities and equipment used in the manufacture, testing and storage of the Product ii. Qualification of packaging equipment iii. Validation of test methods and qualification of persons performing testing iv. Validation of sanitizing and cleaning methods v. Validation of computer systems and logic controllers
23.2 Revalidation is required for transferred Products, and Products for which there has been a significant change to the manufacturing process, including materials and/or equipment. In addition, re-qualification is required for systems that undergo major change or extensive maintenance. Schering and Millennium will decide the number of batches required for revalidation based on significance of the change. This requirement will be satisfied through change control.
23.3 Except to the extent permitted in the relevant Third Party Agreement no changes shall be made to a validated process or system without the written agreement of Schering.
23.4 Millennium will provide to Schering, at Schering's request, specific process validation reports and summaries performed by Millennium, or Millennium's Authorized Contractors. EXHIBIT I LIST OF PRODUCTS INTEGRILIN(R) (eptifibatide) Injection, 0.75 mg/mL, 100 mL INTEGRILIN(R) (eptifibatide) Injection, 2.0 mg/mL, 100 mL INTEGRILIN(R) (eptifibatide) Injection, 2.0 mg/mL, 10 mL
Validation and Qualification