Reference and Retention Samples. 8.1 AMGEN shall retain Reference Samples for each manufactured batch of Product released to AKERO per AMGEN established procedures and cGMP requirements.
Reference and Retention Samples. 12.1 Strakan shall, or shall ensure that its Contract Manufacturer(s), retains reference samples for Additional Material in accordance with EU and US FDA cGMP requirements or, if longer, for a minimum of one (1) year following the expiration of the last Lot of Product containing said Additional Material and in an amount sufficient to comply with any specific regulatory requirements applicable to the Additional Material and, in any case, sufficient to allow at least two (2) full rounds of release tests.
Reference and Retention Samples. Ensuring Storage of Reference Samples of starting materials and finished packs at Strakan or its Contract Manufacturer(s) X Complaints Maintain customer complaint file X X Notify Strakan of complaints requiring investigation X Investigate complaint in collaboration with the Contract Manufacturer(s) X Prepare investigation report and circulate to Aptalis. X Final review and assessment of complaint. X Feedback to complainant X Notify Aptalis of complaints received directly from customers. X * Confidential treatment requested. APPENDIX 4 DIVISION of PHARMACEUTICAL RESPONSIBILITIES CHECKLIST (cont’d) Topic Aptalis Strakan Product Recall Initiate recall procedure X Investigate the requirement to recall X X Notify Regulatory Authorities of decision to recall X Conduct recall X Ensure corrective and preventative action plans are implemented X X Change Control Notification of changes to Specifications to Strakan X Notification to Aptalis of proposed changes to Specifications X Auditing Auditing of Strakan or its Contract Manufacturer(s) for compliance with cGMP X X Auditing of supplier of active ingredients, excipients, packaging components for compliance with cGMP X X Auditing Supplier of Product (Strakan) for Compliance with cGMP X * Confidential treatment requested. APPENDIX 5 CONTACT NAMES For Strakan International S.à x.x. : Responsibility: [*] Name: [*] Job Title: [*] Address: [*] Telephone Number: [*] Fax Number: [*] E-mail: [*] Responsibility: [*] Name: [*] Job Title: [*] Address: [*] Telephone Number: [*] Fax Number: [*] E-mail: [*] Responsibility: [*] Name: [*] Job Title: [*] Address: [*] Telephone Number: [*] Fax Number: [*] E-mail: Complaints: [*] * Confidential treatment requested. APPENDIX 5 CONTACT NAMES (cont’d) For Strakan International S.à x.x.: Responsibility: [*] Name: [*] Job Title: [*] Address: [*] Telephone Number: [*] Fax Number: [*] E-mail: [*] Deputy Name: [*] Job Title: [*] Address: [*] Telephone Number: [*] Fax Number: [*] E-mail: [*] * Confidential treatment requested. APPENDIX 5 CONTACT NAMES (cont’d) For Aptalis Pharma US, Inc.: Responsibility: [*] Name: [*] Job Title: [*] Address: [*] Telephone Number: [*] Fax Number: [*] E-mail: [*] Responsibility: [*] Name: [*] Job Title: [*] Address: [*] Telephone Number: [*] Fax Number: [*] E-mail: [*] Responsibility: [*] Name: [*] Job Title: [*] Address: [*] Telephone Number: [*] Fax Number: [*] E-mail: [*] * Confidential treatment requested. APPENDIX 6 LIST OF CURRENT SUBCONTRACTORS Name & Add...
Reference and Retention Samples. 4.18.1 Excipient and Active Ingredient Reference Sample X 4.18.2 Finished Product Retention Sample X
Reference and Retention Samples. VIFOR or its subcontractors shall properly store and retain (i) Reference Samples of Starting Materials released for and used to Manufacture Product (except water, compressed gases and highly volatile substances), (ii) Reference Samples of Bulk Product and (iii) Retention Samples of Product in conditions and quantity consistent with GMP. Unless applicable Laws require longer retention periods, the aforesaid samples shall be retained for a minimum period of 1 year beyond the shelf-life of the applicable Batch of Product.
Reference and Retention Samples. 4.18.1 Excipient, Primary and Printed Packaging Materials, and Active Ingredient Reference Sample X 4.18.2 Finished Product Retention Sample X X 4.18.3 Sample Destruction (X) X Master Manufacturing Services Agreement
Reference and Retention Samples. 4.17.1 Excipient and Active Ingredient Reference Sample [**] [**]
Reference and Retention Samples. 28.1 Manufacturer or its subcontractors are responsible for collecting and keeping Reference and Retention Samples of each batch of products. These Reference and Retention Samples shall be kept for at least one (1) year after the expiry date of the products according to Good Manufacturing Practices. The size of Reference and Retention Samples must be such that it is possible to perform at least two (2) full quality control analyses by the German authority and the TFDA (in total four (4) full quality control analyses). --- --- ×
Reference and Retention Samples. 5.1 EZN shall retain reference samples of all starting materials to the Product, including but not limited to active pharmaceutical ingredients, excipients (except for gases, solvents and water) and packaging materials (the “Starting Materials”) until expiry date of the last batch of Final Product it was used for or in compliance with current GMP guidelines. Retention samples of the manufactured Final Product must be taken in a quantity sufficient for two full analytic controls, and they must be kept for twenty-four (24) months past the expiry date.
Reference and Retention Samples. 8.1 AMGEN shall retain reference samples for each manufactured batch of Product released to STANFORD per AMGEN established procedures and cGMP requirements.
