Batch Documentation. Company will maintain original batch documentation for each Batch as set forth in the Quality Agreement.
Batch Documentation. 4.1 Originals of all batch documents will be retained by the Contractor according to regulatory and Contractor requirements; these records will be maintained for a period of one (1) year following the Product lot’s expiration date.
Batch Documentation. 4.1 GTC shall prepare or have prepared relevant written Source Material Collection, clarification, purification, and quality control documents according to its internal procedures and standards. These documents shall be approved by GTC, and made reasonably available to MERRIMACK upon written request. MERRIMACK shall at its option review and approve all MERRIMACK specific batch documentation and release testing documentation.
Batch Documentation. 4.1 Originals of all batch documentation and associated retain samples will be retained by Patheon for a period of one year past the expiry date of the Product at which time the Client will be contacted concerning the future storage or destruction of the documentation. Client to have option of taking ownership of completed batch records, copies of analytical data, and product retains at the end of the storage period.
Batch Documentation. 6.1. ELAN will retain batch records and related documents in accordance with regulatory and corporate retention requirements.
Batch Documentation. 8.1 The Contractor will deliver to the Customer a Certificate of Analysis with all the release records signed and approved by the Contractor for each batch of Products, certifying that the Contractor has the Batch Documentation and supportive test results with respect to each batch of Products manufactured and delivered to the Customer pursuant to this Agreement, demonstrating that the product release specifications, as defined in the quality agreement, have been met. The Contractor represents and warrants that the Certificate of Analysis, the Batch Documentation and other documentation supplied to the Customer under this Agreement will be accurate and complete. If the Customer requires supplemental documents from the Contractor, including and without limitation in order to obtain or in connection with any Regulatory Authority approvals for the Product, or in connection with any Product recall, the Contractor agrees to cooperate with the Customer and to make available to the Customer such additional or supplemental documentation as may reasonably be requested by the Customer. The Customer shall bear all pre-approved costs and expenses related to obtaining the above mentioned supplemental documents. The Contractor will retain originals of all Batch Documentation, any and all other documentation generated by it in connection with the processing and testing of the Products under the terms of this Agreement, and all records which may be reasonably necessary to assist the Customer in the event of a product recall or otherwise, for not less than five (5) years after the date of expiration of date of the Batch of Product to which they pertain and, if longer, such period as is required by local regulations in force in the Territory.
Batch Documentation. SCHERING will document the conduct of all the procedural steps stipulated in the Manufacturing Description as well as all in-process controls in Batch-specific records as customarily kept by SCHERING. SCHERING will provide INDEVUS with timely notification of all significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the Finished Product, as well as all FDA correspondence regarding testing, Manufacture, Final Packaging, or Packing of the Finished Product. SCHERING will provide INDEVUS with a complete copy of - 44 - the Executed Batch Records of the first [*] Batches of Finished Product. An English version of the Master Batch Record for Finished Product will be provided to INDEVUS. Such records will be provided to INDEVUS prior to shipment of such Batches in accordance with the provisions of Section 5.6 of the MSA. The records must be accompanied by a Certificate of Compliance (COC) and a Certificate of Analysis (COA) for the Substance used in Finished Product and the Finished Product. Deviation and Out of Specification (OOS) reports will be included if applicable, which detail in writing any problems and deviations within the Manufacturing process and analytical testing. The accompanying COC, COA, and deviation and OOS reports will be provided in English. All additional Batches will be accompanied by some pages of the Executed Batch Record mutually agreed between the Parties, the COA and the COC for Substance used in Finished Product and for Finished Product, and, if applicable, deviation and OOS reports. SCHERING will retain the complete Batch documentation for at least [*] after the expiration date of the respective Batch as required by cGMP regulations, especially US federal regulation 21CFR211.180. SCHERING will provide these records to INDEVUS on reasonable request. SCHERING will present Manufacturing and testing documentation to Regulatory Authorities upon request as appropriate and in the manner required by cGMP regulations, especially US federal regulation 21CFR211.180(c) and (d). To the extent not covered by this Section 5.2, the provisions of Section 6.2 of the MSA shall also govern any records and Documentation.
Batch Documentation. 12.1 BIO HOSPITAL shall document the conduct of all the procedural steps stipulated in the Master Batch record as well as all in-process controls in Batch-specific records as customarily kept by BIO HOSPITAL. BIO HOSPITAL provide OCEANA with timely notification of al significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the product, as well as copies of all FDA correspondence regarding Processing. The Quality Assurance Department of BIO HOSPITAL shall be responsible for determining Product batch suitability for approval for each batch of the Product. BIO HOSPITAL shall provide OCEANA with a complete copy of the Executed Batch Records in English. Such records shall be provided to OCEANA prior to shipment of such Batches. OCEANA Quality Assurance shall have no more than 15 business days to review the Executed Batch Records. OCEANA Quality assurance shall provide disposition of Product to BIO HOSPITAL Quality Assurance before shipment of Product can occur. OCEANA shall be responsible for the final disposition of each PRODUCT batch. The Executed Batch records must be accompanied by a Certificate of Compliance (COC) / Certificate of Release (COR) and a Certificate of Analysis (COA) for the Product. Deviation and Out of Specification (OOS) reports shall be included if applicable, which detail in writing any problems and deviations within Processing. BIO HOSPITAL shall retain the complete Batch documentation for at least one (1) year after the expiration date of the respective Batch as required by cGMP regulations, especially US federal regulation 21 CFR 211.180. BIO HOSPITAL shall provide copies of these records to OCEANA on reasonable request. BIO HOSPITAL shall notify OCEANA prior to destruction of documents and provide them to OCEANA if requested.
Batch Documentation. Sanofi shall ensure that KaloBios is provided with copies of all of the batch release documentation (as defined in Section 6.3) for Bulk Substance Manufactured by Sanofi or its subcontractor at the time of delivery to KaloBios of the Bulk Substance, except when KaloBios has agreed to have Bulk Substance shipped to it under quarantine; in which case Sanofi shall provide all outstanding documentation to KaloBios as soon as it is available.
Batch Documentation. 4.1 Originals of all batch documentation and associated retain samples will be retained by Patheon for a period of one year past the expiry date of the Product at which time the Client will be contacted concerning the future storage or destruction of the documentation. Client to have option of taking ownership of completed batch records, copies of analytical data, and product retains at the end of the storage period. 4.2 At the request of the Client, Patheon agrees to provide a copy of any of the executed batch documents relating to Products to the Client by facsimile or courier within two Business Days. ARTICLE 5 STABILITY 5.1 Patheon shall perform such stability testing as described in a stability protocol agreed to by both Patheon and the Client. <PAGE> 5.2 If a confirmed result indicates that a Product has failed to remain within stability specifications, Patheon will notify the client within one Business Day. 5.3 Stability data will be provided by Patheon to the Client on an ongoing basis as agreed to by both parties. 5.4 In the event that the MSA is terminated, Patheon will continue to provide the Client with stability data supporting the acceptability of the Product until all such Product distributed by the Client has reached the end of its shelf-life. ARTICLE 6 VALIDATION 6.1 Client must ensure that their analytical methods and manufacturing procedures (including packaging procedures) are validated. 6.2 If such methods and procedures are not validated by the Client, then Patheon may assist in validation development with the costs being borne by the Client. ARTICLE 7 GENERAL 7.1 Any communications with respect to the subject matter of this Agreement shall be directed, in the first instance, to the person(s) identified in Schedule B hereto. <PAGE> 7.2 Capitalized terms not otherwise defined herein shall have the meaning specified in the MSA. <PAGE> 7.3 To the extent of any inconsistency between the terms of this Quality Agreement and the terms of the MSA the terms of the MSA shall govern. CRITICAL THERAPEUTICS, INC., PATHEON PHARMACEUTICALS INC., Name: /s/ Xxxxxx Xxxxxx Name: /s/ Xxxx Xxxxx ------------------------------- ---------------------------------- Signature: /s/ Xxxxxx Xxxxxx Signature: /s/ Xxxx Xxxxx -------------------------- ----------------------------- Date: 6 April 2005 Date: 4/7/05 <PAGE> SCHEDULE A PRODUCT(S) <TABLE> <CAPTION> PRODUCT(S) GALENIC FORM DOSAGE (STRENGTH) ---------- ------------ ----------------- <S> <C> <C> Zyflo IR Tab...
