Responsibilities of the production unit
Article 7
The responsibilities for production activities shall be documented in writing, and shall include at least the following elements: — preparation, review, approval and distribution of the instructions for the production of active substances or intermediates thereof in accordance with written procedures; — production of active substances and, when appropriate, intermediates in accordance with pre-approved instructions; — review of all production batch records and ensuring that they are completed and signed; — reporting and evaluation of all production deviations, investigation of critical deviations and recording of the conclusions; — cleaning and when appropriate disinfection of production premises; — performing of the calibrations and keeping the records of those calibrations; — maintenance of the premises and equipment and keeping the records of the maintenance activities; — review and approval of the validation protocols and reports; — evaluation of proposed changes in product, process or equipment; — ensuring the qualification of new and modified facilities and equipment.