Common use of Quality Assurance and Quality Control Clause in Contracts

Quality Assurance and Quality Control. 6.1 Where Regulatory Inspections or PURCHASER audits identify quality and compliance issues SUPPLIER shall agree to implement corrective and preventative action. 6.2 SUPPLIER shall notify PURCHASER of any regulatory inspections that are announced that may directly or indirectly impact on the PRODUCTS supplied to the PURCHASER. SUPPLIER shall inform PURCHASER of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to PURCHASER . SUPPLIER shall review any responses to Regulatory Authorities with the PURCHASER that may directly or indirectly impact on the PRODUCTS prior to submission to the Regulatory Authorities by SUPPLIER. 6.3 SUPPLIER is responsible for the quality control of the PRODUCTS, including testing, documentation review, retention of samples and producing required documentation as defined in cGMPs. 6.4 SUPPLIER shall, where required, develop internal control limits in coordination and agreement with PURCHASER including limits, that support the expiry period of the PRODUCTS in the Details. Where these internal control limits are agreed, batches failing the internal control limits shall not be shipped to PURCHASER until the SUPPLIER conducts and appropriate investigation and the outcome accepted by the PURCHASER. 6.5 SUPPLIER shall supply an agreed Certificate of Analysis (COA) as defined in Appendix 6, and an agreed Certificate of Compliance (COC) as defined in Appendix 7 for PRODUCTS indicating that the batch complies with all agreed specifications and cGMPs prior to dispatch for review and assessment by the PURCHASER. 6.6 PURCHASER shall review and access Certificate of Analysis (COA) and Certificate of Conformance (COC). 6.7 PURCHASER shall confirm the identity of PRODUCTS within 60 days of receipt of PRODUCTS from SUPPLIER . PURCHASER shall undertake any additional tests, as PURCHASER deems appropriate. 6.8 SUPPLIER shall investigate all non-conformities, deviations and out of specification (OOS) results in accordance with cGMPs and shall inform the PURCHASER of the outcome of investigations. 6.9 SUPPLIER shall inform PURCHASER of any incidents that may affect conformance of the PRODUCT to the Specifications. 6.10 SUPPLIER shall retain batch documentation for 5 years. 6.11 SUPPLIER shall retain retention samples from each batch of the PRODUCTS and starting materials in accordance with cGMPs. For the subsequent stages that are conducted at the PURCHASER’s facility, PURCHASER shall retain retention samples from each batch of the resultant product in accordance with cGMPs. 6.12 SUPPLIER shall be responsible for the specification of packaging components. SUPPLIER shall be responsible for the quality control and labelling of packaging components in accordance with the approved packaging text. PURCHASER shall provide the artworks and packaging specifications. 6.13 SUPPLIER shall retain records necessary to ensure traceability from initial raw materials through to each finished product.

Quality Assurance and Quality Control. 6.1 Where Regulatory Inspections or PURCHASER audits identify quality and compliance issues SUPPLIER shall agree to implement corrective and preventative action. 6.2 SUPPLIER shall notify PURCHASER of any regulatory inspections that are announced that may directly or indirectly impact on the PRODUCTS supplied to the PURCHASER. SUPPLIER shall inform PURCHASER of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to PURCHASER . SUPPLIER shall review any responses to Regulatory Authorities with the PURCHASER that may directly or indirectly impact on the PRODUCTS prior to submission to the Regulatory Authorities by SUPPLIERPURCHASER. 6.3 SUPPLIER is responsible for the quality control of the PRODUCTS, including testing, documentation review, retention of samples and producing required documentation as defined in cGMPsGMPs. 6.4 SUPPLIER shall, where required, develop internal control limits in coordination and agreement with PURCHASER including limits, that support the expiry period of the PRODUCTS in the Detailsfor production processes. Where these internal control limits are agreed, batches failing fail the internal control limits limits, the product shall not be shipped to PURCHASER until the PURCHASER. Development of limits for expiration will be developed by SUPPLIER conducts and appropriate investigation and the outcome accepted by notified to the PURCHASER. 6.5 SUPPLIER shall supply an agreed Certificate of Analysis (COA) as defined in Appendix 6, and an agreed Certificate of Compliance (COC) as defined in Appendix 7 for PRODUCTS indicating that the batch complies with all agreed specifications and cGMPs prior to dispatch for review and assessment by the PURCHASERGMPs. 6.6 PURCHASER shall review and access Certificate of Analysis (COA) and Certificate of Conformance (COC). 6.7 PURCHASER shall confirm perform visual (label) inspection of the identity of PRODUCTS within 60 30 days of receipt of PRODUCTS from SUPPLIER . PURCHASER shall undertake any additional tests, as PURCHASER deems appropriateSUPPLIER. 6.8 SUPPLIER shall investigate all non-conformities, deviations and out of specification (OOS) results in accordance with cGMPs GMPs and shall SUPPLIER will inform the PURCHASER of the outcome of investigationsany major or critical deviations/non-conformities and OOS results in accordance with GMPs. If product does not conform to specifications, it will not be supplied to PURCHASER. 6.9 SUPPLIER shall inform PURCHASER of any incidents that may affect conformance of the PRODUCT to the Specifications. 6.10 SUPPLIER shall retain batch documentation for 5 years. 6.11 SUPPLIER shall retain retention samples from each batch of the PRODUCTS and starting materials in accordance with cGMPsGMPs. For the subsequent stages that are conducted at the PURCHASER’s 's facility, PURCHASER shall retain retention samples from each batch of the resultant product in accordance with cGMPsGMPs. 6.12 SUPPLIER shall be responsible for the specification of packaging components. SUPPLIER shall be responsible for the quality control and labelling of packaging components in accordance with the approved packaging text. PURCHASER shall provide the artworks artwork and packaging specifications. 6.13 SUPPLIER shall retain records necessary to ensure traceability from initial raw materials through to each finished product.