Common use of Documentation and Records Clause in Contracts

Documentation and Records. 5.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. X 5.02 Have written procedures for the review and approval of all batch documentation. X 5.03 Maintain a document control system for specifications and test methods, including: raw materials, Product labeling, packaging materials and other materials that would likely affect product quality. X 5.04 Review and approval of specifications and test methods, including: Product labeling, packaging materials and other materials that would likely affect product quality. X X 5.05 Provide a complete Certificate of Analysis for the Product, containing “at minimum” the following information: Supplier Product number Supplier lot/batch number. Name of Product Name of the tests Specification limit Expiration or retest date, if applicable Test result (as a numerical value, unless designated Pass/Fail in the specification limit, statistical values can be used if data supports their use except for assays and impurity tests), including retest results if required Quality Assurance approval and date. Manufacturing Site (name and address) Manufacturing Date X 5.06 Provide certification that the Product was manufactured in a cGMP compliant facility and was tested in accordance with and meets specifications X 5.07 Where applicable, electronic signatures used on the certificate of analysis or other controlled documents should be authenticated and secure. X 5.08 Archiving the original documents X

Documentation and Records. 5.01 8.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records Records should be retained for at least 1 one (1) year after the expiry date of the batch. For APIs Product with a retest datesdate, records Records should be retained for at least 3 three (3) years after the batch is completely distributed. X. 5.02 8.02 Have written procedures for the review and approval of all batch documentation. X. 5.03 8.03 Maintain a document control system for specifications and test methods, including: raw materials, Product labeling, packaging materials and other materials that would likely affect product Product quality. X. 5.04 Review and approval of specifications and test methods, including: Product labeling, packaging materials and other materials that would likely affect product quality. X X 5.05 8.04 Provide a complete Certificate of Analysis for the Product, containing “"at minimum” " the following information: Supplier Product number number/code Supplier lot/batch number. number Name of Product Name of the tests test Specification limit Expiration or retest date, if applicable Test result (as a numerical value, unless designated Pass/Fail in the specification limit, statistical values can be used if data supports their use except for assays and impurity tests), including retest results if required Quality Assurance approval and date. Manufacturing Site (name and address) Manufacturing Date XDate 5.06 8.05 Provide certification that the Product was manufactured in a cGMP compliant facility facility, and was tested in accordance with and meets specifications Xspecifications. This may be provided on the Certificate of Analysis itself, or a separate Certificate of Conformance. 5.07 8.06 Where applicable, electronic signatures used on the certificate Certificate of analysis Analysis or other controlled documents should be authenticated and secure. X 5.08 Archiving the original documents X.