Manufacturing Documentation Clause Samples
The Manufacturing Documentation clause requires the provision, maintenance, or sharing of documents related to the manufacturing process of a product. This typically includes specifications, quality control records, process instructions, and compliance certificates, which may need to be delivered to the other party or kept available for inspection. Its core function is to ensure transparency and traceability in manufacturing, helping both parties verify that products meet agreed standards and regulatory requirements.
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Manufacturing Documentation. The Manufacturing Documentation is complete, correct, and up-to-date and, together with the content of the documents and other items listed therein, describes the Seller Manufacturing Process in sufficient detail to enable reasonably trained and qualified personnel to operate the Seller Manufacturing Process as operated by Seller prior to the Closing Date (while redacting Excluded Technology).
Manufacturing Documentation. All of Seller's right, title, and interest in all manufacturing documentation associated with the seismograph product lines listed on Schedule 1.
Manufacturing Documentation shall maintain in the English language, complete, true and accurate Manufacturing Documentation, and shall keep them in strict confidence and shall not use them for purposes other than providing or performing the Service or other obligations hereunder. * shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG or such longer period as may be required by Applicable Law. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation, including the Batch Records, at the Facility as further defined in the applicable QAG; provided, however, * shall not delay any such request of Client for more than fifteen (15) Business Days. Client may also request scanned or printed copies of such Manufacturing Documentation, but shall be responsible for reasonable costs associated therewith. * shall record and maintain such records, data, documentation and other information in the language as so required in the applicable QAG or as so required by a Regulatory Authority and in compliance with Applicable Law, or as otherwise may be set forth in an applicable PSA. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of *. Notwithstanding anything to the contrary, * SOPs not specific to the Client’s Products may be provided to Client for on-site review if deemed necessary by both * and Client. Such SOPs cannot be removed from the * premises, copied, photographed or otherwise replicated, but to the extent required for filing in connection with any Regulatory Approval related to a Product including, but not limited to, an IND, BLA or MAA, * will file, maintain and update such SOPs with appropriate Regulatory Authorities by means of a Drug Master File, Common Technical Document or other means by which such SOPs may remain confidential, but available by reference to Client to effect Regulatory Approvals, and * shall formally authorize such reference.
Manufacturing Documentation. Unless applicable Laws or GMP requires longer retention periods, VIFOR or its subcontractors shall retain Batch Manufacturing records for a period of (expiry date + 1 year) beyond the shelf-life of the applicable Batch of Product. Unless applicable Laws require a longer retention period, DISTRIBUTOR shall retain Product distribution records for a period of (expiry date + 1 year) beyond the shelf-life of the applicable Batch of Product.
Manufacturing Documentation. Matricel will maintain original manufacturing documentation according to record retention procedure consistent with FDA requirements.
Manufacturing Documentation. 3.4.1 FRESENIUS KABI will maintain the batch identification system for the PRODUCT Manufactured by FRESENIUS KABI (i.e. batch number assignment) and ensure that unique batch numbers are used for each batch of the PRODUCT. X
3.4.2 FRESENIUS KABI will compile the BOM for PRODUCT Manufacturing with CSI’s final approval. X X
3.4.3 FRESENIUS KABI will maintain all batch records and associated PRODUCT documentation for a minimum of one year beyond expiry date of the PRODUCT. FRESENIUS KABI shall keep validation batch production and testing records permanently. X
3.4.4 FRESENIUS KABI will ensure executed batch records contain the following information to meet Device History Record (DHR) requirements. • Dates of manufacture; • Quantity manufactured; • Quantity released for distribution; • Acceptance records which demonstrate the device is manufactured in accordance with the DMR; • The primary identification label and labeling used for each production unit; and • Any identification(s) and control number(s) used. X
3.4.5 FRESENIUS KABI will draft and approve master Manufacturing batch records. X
3.4.6 FRESENIUS KABI shall Manufacture the PRODUCT in accordance with principles of cGMP as described by the Regulatory Authority appropriate for the type of PRODUCT. X
3.4.7 FRESENIUS KABI shall assure that the PRODUCT is Manufactured, Packaged, held, labeled, and tested according to FRESENIUS KABI’s procedures and batch records and fulfills the PRODUCT Specification. X
Manufacturing Documentation. On or before [***] days from the Effective Date, Archemix shall provide Ophthotech with a copy of Item 7 (entitled “Chemistry, Manufacturing & Control”) of the IND application prepared by Archemix for ARC1905 dated December 15, 2005. Upon Ophthotech’s request, Archemix shall provide Ophthotech with copies of the supporting documents or records for such Item 7. Ophthotech shall be responsible for paying all costs including, without limitation, Archemix’s FTE Costs and any external expenses incurred by Archemix, associated with the transfer of any such documents or records to Ophthotech under this Section 3.5.4; provided, that, Archemix may redact any portion of such documentation and records as it reasonably determines contains Confidential Information of a Third Party.
Manufacturing Documentation. Formosa is responsible for the preparation and revision of Master Batch Records, Test Methods and Shipping Instructions for the Product. Formosa will provide these documents to NGX for review and approval before they are used in any manufacturing, testing or shipping operations. Editorial changes or changes in formatting that do not change the content of the document do not require NGX prior approval, however, copies of the revised documents will be provided to NGX immediately after the change has been implemented.
Manufacturing Documentation. SBL shall maintain in the English language, complete, true and accurate Manufacturing Documentation, and shall keep them in strict confidence and shall not use them for purposes other than providing or performing the Service or other obligations hereunder. SBL shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG or such longer period as may be required by Applicable Law. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation, including the Batch Records, at the Facility as further defined in the applicable QAG; provided, however, SBL shall not delay any such request of Client for more than fifteen (15) Business Days. Client may also request scanned or printed copies of such Manufacturing Documentation, but shall be responsible for reasonable costs associated therewith. SBL shall record and maintain such records, data, documentation and other information in the language as so required in the applicable QAG or as so required by a Regulatory Authority and in compliance with Applicable Law, or as otherwise may be set forth in an applicable PSA. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of SBL. Notwithstanding anything to the contrary, SBL SOPs not specific to the Client’s Products may be provided to Client for on-site review if deemed necessary by both SBL and Client. Such SOPs cannot be removed from the SBL premises, copied, photographed or otherwise replicated, but to the extent required for filing in connection with any Regulatory Approval related to a Product including, but not limited to, an IND, BLA or MAA, SBL will file, maintain and update such SOPs with appropriate Regulatory Authorities by means of a Drug Master File, Common Technical Document or other means by which such SOPs may remain confidential, but available by reference to Client to effect Regulatory Approvals, and SBL shall formally authorize such reference.
Manufacturing Documentation. SBL shall maintain Manufacturing Documentation to be true and accurate, and shall keep in strict confidence and shall not use for purposes other than providing or performing the Service or other obligations hereunder. SBL shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation, including the Batch Records, at the Facility as further defined in the applicable QAG. Client may also request scanned or printed copies of such Manufacturing Documentation, but shall be responsible for reasonable costs associated therewith. SBL shall record and maintain such records, data, documentation and other information in the language as so required in the applicable QAG or as so required by a Regulatory Authority and in compliance with Applicable Law. To the extent necessary, SBL may redact or withhold Manufacturing Documentation provided pursuant this MSA or any applicable PSA to protect the confidential information of its other clients or third parties. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of SBL. Notwithstanding anything to the contrary, SBL SOPs not specific to the Client’s Products may be provided to Client for on-site review if deemed necessary by both SBL and Client. Such SOPs cannot be removed from the SBL premises, copied, photographed or otherwise replicated.