Common use of Master Batch Record Clause in Contracts

Master Batch Record. Prior to DMF Approval, CPI will manufacture and bulk package the Drug Resin Complex in accordance with the ANDA and applicable Laws. Following DMF Approval, CPI will manufacture and bulk package the Drug Resin Complex in accordance with the DMF and applicable Laws. CPI is responsible for preparing the master batch records for manufacture and bulk packaging of the Drug Resin Complex. Prior to DMF Approval, the Regulatory Consultant, is responsible to review and approve the master batch records for the manufacture and bulk packaging of Drug Resin Complex. Following DMF Approval, CPI will follow their approved SOP’s to fully investigate any “for cause” circumstances and provide Neos a written summary of those findings CPI will not make changes to master batch records except through an established change control system. CPI shall provide Neos with written notification of significant changes made to the Drug Resin Complex batch records that may directly impact Neos’s manufacture of Generic Tussionex.