Notification and Approval of Deviations. AND NON-CONFORMANCE 10 Article 12 REFERENCE AND RETENTION SAMPLES 12 Article 13 STORAGE OF PRODUCT / ENVIRONMENTAL MONITORING 12 Article 14 COMPLAINTS 13 Article 15 CHANGE CONTROL 13 Article 16 REPROCESSING AND REWORK 14 Article 17 SUB-CONTRACTING 14 Article 18 REGULATORY INSPECTIONS 14 Article 19 PERIODIC QUALITY REVIEWS 15 Article 20 ON-GOING GMP STABILITY 15 Article 21 ANNUAL REPORT 15 * Confidential treatment requested. Article 22 CHANNELS OF COMMUNICATION 15 Article 23 REVIEW 15 APPENDIX 1 FINISHED PRODUCT LISTING 1-1 APPENDIX 2 CONTRACT MANUFACTURER AUTHORIZATION TO MANUFACTURE 2-1 APPENDIX 3 SUMMARY OF MARKETING AUTHORIZATION 3-1 APPENDIX 4 DIVISION OF PHARMACEUTICAL RESPONSIBILITIES CHECKLIST 4-1 APPENDIX 5 CONTACT NAMES 5-1 APPENDIX 6 LIST OF CURRENT SUBCONTRACTORS 6-1 APPENDIX 7 CHANGE HISTORY LOG 7-1 APPENDIX 8 LIST OF APPROVED SUPPLIERS 8-1 * Confidential treatment requested.
Notification and Approval of Deviations. 9.1 EZN will investigate and document all deviations, out-of-specification results, non-compliance with Good Manufacturing Practices, production failures or product complaints or any other matter that may affect the quality, safety or efficacy of the Product. Documentation will be retained as part of the batch documentation for the batch affected.
Notification and Approval of Deviations. BioVectra will have a documented system for handling deviations, deviation investigations, and corrective actions. All deviations will be investigated and fully documented by BioVectra. BioVectra is to notify Omthera of any deviations according to the Quality Agreement. ***Confidential Treatment Requested Omthera BioVectra ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 230.406 BioVectra will retain such documentation as part of the batch documentation for the batch affected.
Notification and Approval of Deviations. Ensure a thorough investigation and justification of any deviation to stated procedures or out of specification (OOS) result X Ensure all investigation reports are reviewed and completed prior to completion of the batch production record review X Promptly notify Customer within 3 business days of initiation of investigation of any deviation or OOS that affects the material or Product being tested per BVL SOP. X Provide technical, compliance, and regulatory oversight in support of the investigation X Hold and segregate material or Product that does not conform to in-process or release specifications. X Prepare and approve investigation report X Review and release/reject material or Product Batch as an outcome of an approved investigation report. X X Disposition Product as an outcome of the approved investigation X Establish procedures for the releasing/rejecting failed Batches of raw material or Product. X Promptly notify Customer of cause for investigation and proposed action plan for raw material or Product failures. X Participate in Product investigations, as needed. X Generate Investigation Report. X X Review and approve Investigation Report X X
Notification and Approval of Deviations. BioVectra will have a documented system for handling Deviations, Deviation investigations, and corrective actions. All Deviations will be investigated and fully documented by BioVectra. BioVectra is to notify Questcor within five (5) business days from the time that BioVectra discovers the Deviation. All Deviations (including the final report which outlines the Deviation, investigation and corrective actions taken) must be reviewed and approved by Questcor. BioVectra will retain such documentation as part of the batch documentation for the batch affected. Shipment of a lot shall not occur until Questcor has approved all Deviations.
Notification and Approval of Deviations. BVL must notify Customer within three (3) business days from the initiation of the investigation, whenever there is a significant deviation from stated procedures or specifications. A significant deviation is defined as any Out Of Specification (OOS) result and/or any manufacturing, packaging, labeling, or testing deviation that may affect the quality, safety or efficacy of the Product. BVL will only release/reject a Product Batch as an outcome of a BVL and Customer approved investigation report. In the event of conflict, BVL may release or reject any Product Batch at its sole discretion. Customer is responsible for the final product disposition of a product released by BVL. All deviations will be investigated and fully documented by BVL in accordance to BVL procedures. This documentation will be retained as part of the batch documentation for the Batch affected. When deemed necessary, Customer reserves the right to request the need for a more in-depth investigation of the deviation by BVL. BVL and Customer will work together in determining the need for additional investigational work. Customer approval shall be obtained in writing (fax or PDF electronic document confirmation is acceptable) for any significant deviation. Customer approval shall not be unreasonably withheld. Customer and BVL will Quality Agreement (BVL and Theravance) jointly provide the documented product impact assessment for all deviations that impact the Product. The documented assessment must be received within 5 (five) business days of the completion of the investigation. In cases where Customer requests a deviation, the request must be submitted in writing. Customer is responsible for notifying the FDA regarding any required Field Alert Report according to 21 CFR 314.81. BVL shall be notified by the Customer of any Field Alerts filed for Product. The Investigation Report for significant deviations will be approved by both BVL and Customer as stated below. The approved document will become part of the batch record of that specific lot of material. Any resulting corrective and preventative actions shall be followed through timely closure in accordance to BVL procedure. Approval by the appropriate Quality Assurance functions is solicited and may be obtained via fax or electronic copy. Failure Approval Requirements Product Customer and BVL Raw Materials sourced and used by BVL BVL In the event of a dispute regarding the failure of Product, an independent, mutually acceptable qualified Th...
Notification and Approval of Deviations. BioVectra will have a documented system for handling Deviations, Deviation investigations, and corrective actions. All Deviations will be investigated and fully documented by BioVectra. BioVectra is to notify PhaseBio of any Deviations according to the Quality Agreement. BioVectra will retain such documentation as part of the Batch documentation for the Batch affected.
Notification and Approval of Deviations. Should there be a significant deviation from stated production, processing and packaging specifications, OFL will notify RMHB within two (2) working days from time of discovery. A significant deviation is defined as any Out-Of-Specification (“OOS”) result and/or any production, processing, packaging, labeling, or testing deviation that may affect the quality, safety, or efficacy of the Products. All deviations will be investigated and fully documented by OFL. This documentation will be retained as part of the documentation for the batch (lot) affected. When deemed necessary, RMHB reserves the right to request additional or more in-depth investigation of the deviation by OFL. In all cases when a significant deviation occurs on a batch, RMHB will have the final review and decision-making responsibility as to the impact of the deviations on the Products, which will include the disposition of the affected batches (lots).
Notification and Approval of Deviations. When there is a significant deviation from stated procedures or stated specifications, Supplier must notify Company within 2 working days from time of discovery. A significant deviation is defined as any Out-Of-Specification (“OOS”) result and/or any manufacturing, bulk packaging, bulk labeling, or testing deviation that may affect the quality, safety, or efficacy of the Beverages. Reprocessing will be considered a significant deviation. All deviations will be investigated and fully documented by Supplier. This documentation will be retained as part of the batch documentation for the batch (lot) affected. When deemed necessary, Company reserves the right to request additional or more in-depth investigation of the deviation by Supplier. In all cases when a significant deviation occurs on a batch, Company will have the final review and decision-making responsibility as to the impact of the deviations on the Beverages, which will include the disposition of the affected batches (lots).
Notification and Approval of Deviations. BVL must notify Customer within three (3) business days from the initiation of the investigation, whenever there is a significant deviation from stated procedures or specifications. A significant deviation is defined as any Out Of Specification (OOS) result and/or any manufacturing, packaging, labeling, or testing deviation that may affect the quality, safety or efficacy of the Product. BVL will only release/reject a Product Batch as an outcome of a BVL and Customer approved investigation report. In the event of conflict, BVL may release or reject any Product Batch at its sole discretion. Customer is responsible for the final product disposition of a product released by BVL. Manufacturing and Service Agreement (BVL and Vion Pharmaceuticals, Inc.)
