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.
Appears in 1 contract
Sources: Scale Up and Commercial Supply Agreement (Adolor Corp)
cGMP Documentation. Throughout the Term, each Each Party shall maintain, in accordance with and for the period required under the NDA, cGMPs, laws cGMPs and Regulatory Standardsapplicable Laws, 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 AuthoritiesProducts.
Appears in 1 contract
Sources: Row Supply Agreement (Adolor Corp)