cGMP Documentation Sample Clauses
The cGMP Documentation clause requires parties to maintain and provide records that demonstrate compliance with current Good Manufacturing Practices (cGMP). This typically involves keeping detailed logs of manufacturing processes, quality control measures, and any deviations or corrective actions taken during production. By mandating thorough documentation, the clause ensures traceability, accountability, and regulatory compliance, thereby reducing the risk of product quality issues and facilitating audits or inspections.
cGMP Documentation. Throughout the Term, each Party shall maintain, in accordance with and for the period required under the NDA, cGMPs, laws and Regulatory Standards, complete and adequate records pertaining to the methods and facilities used for the cGMPs pertaining to the manufacture, processing, testing, packaging, packing, labeling, holding and distribution of the Patches. Corium shall also maintain all records related to its compliance with environmental, health and safety guidelines for such periods of time as are required by the applicable Regulatory Authorities.
cGMP Documentation. Supplier shall maintain, in accordance with and for the period required under cGMPs and applicable Laws, complete and adequate records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the API Compound.
cGMP Documentation. CRL shall maintain, in accordance with and for the period required under cGMPs and applicable Laws, complete and adequate records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the Drug Product.
cGMP Documentation. LICENSEE shall not make any changes to Nastech-owned or Nastech-controlled cGMP documentation without the consent of Nastech, in order to insure that all cGMP documentation, which is maintained at Nastech and subject to regulatory review, matches or is consistent with information filed with regulatory authorities. LICENSEE shall be responsible for all costs and penalties incurred if it makes any changes to cGMP documentation without Nastech's consent.
cGMP Documentation. Each Party shall maintain, in accordance with and for the period required under the applicable MAA, cGMPs, and Laws, complete and adequate records pertaining to the methods and facilities used for the cGMPs manufacture, processing, testing, packing, labeling, holding and distribution of the Products. Impax shall also maintain all records related to its compliance with its Environmental, Health and Safety Guiding Principles in accordance with Section 5.6.
cGMP Documentation. PII shall maintain, in accordance with and for the period required under cGMPs and applicable Laws, complete and adequate records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the Drug Product.
cGMP Documentation. Each Party will maintain, in accordance with and for the period required under the applicable Product Addendum, Specifications, cGMPs and Laws, complete and adequate records pertaining to the methods and facilities used for the cGMPs manufacture, processing, testing, packing, labeling, holding and distribution of the Products. Patheon will keep complete and systematic records related to the Materials purchased, Manufacturing Services performed and any other records generated as a part of this Agreement. These records will include any operational documentation pertaining to Patheon’s Manufacturing Services under this Agreement, including procedures (including records for compliance with Laws) and any other documentation pertaining to Patheon’s obligations under this Agreement. Patheon will preserve these records for the greater of (a) [ * ], or (b) the period agreed upon in writing by the Parties in any Product Addendum. If a legal matter arises requiring preservation of certain records and XenoPort or any Governmental Authority has made a request to preserve records, Patheon will suspend destruction of the records.