QUALITY ASSURANCE DOCUMENTATION Clause Samples

QUALITY ASSURANCE DOCUMENTATION. Pfizer will prepare such records documenting the development work as foreseen in the Project Statement of Work or as are otherwise reasonably requested by ▇▇▇▇▇▇▇. Pfizer will prepare batch manufacturing records, which include the information relating to the manufacturing, packaging and quality operations for each lot of Product at the time such operations occur. Pfizer will prepare all development work and batch records in accordance with Applicable Laws, the Quality & Technical Agreement, cGMP and any similar regulations of applicable Regulatory Authorities and Pfizer’s standard operating procedures. Upon ▇▇▇▇▇▇▇’▇ request, Pfizer will provide ▇▇▇▇▇▇▇ with copies of such development records and batch production records, including manufacturing and analytical records.

QUALITY ASSURANCE DOCUMENTATION. This document shall describe the quality assurance program of Systems Provider.

QUALITY ASSURANCE DOCUMENTATION. Each delivery of Products shall be accompanied by documentation in a form agreed between the Managers of Quality Assurance at both parties certifying: (a) that the tests and quality control procedures have been carried out by BioStar on Products delivered prior to delivery and that Products delivered have satisfied these tests and quality control procedures as described; (b) the date of manufacture of Products; and

QUALITY ASSURANCE DOCUMENTATION. Each delivery of Products shall be accompanied by documentation in a form agreed between the Managers of Quality Assurance for both parties.

QUALITY ASSURANCE DOCUMENTATION. 44 4.1.1 Document Review.......................................................................44 4.2 Manufacturing and AIT Quality Assurance........................................................45 4.2.1 QA Management and Planning............................................................45 4.2.2 Procurement...........................................................................45 4.2.3 Incoming Inspection...................................................................46 4.2.4 Manufacturing and Stores Control......................................................47 4.2.5 Assembly and Integration Surveillance.................................................49 4.2.6 Log Documentation and Traceability....................................................51 4.2.7 Delivery Review.......................................................................51 4.2.8 Metrology and Calibration.............................................................51 4.2.9 Cleanliness and Contamination Control.................................................53 4.3 Quality Assurance During the Launch Campaign.......................................................56 4.4.2 Definition of Major and Minor Nonconformances.........................................58 4.4.3 Material Review Dispositions..........................................................58 4.4.4 Material Review Board (MRB)...........................................................59