The authorized person is responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for sale or supply.
Assessment of finished products should embrace all relevant factors, including the production conditions, the results of in-process testing, the manufacturing (including packaging) documentation, compliance with the specification for the finished product, and an examination of the finished pack.
No batch of product is to be released for sale or supply prior to certification by the authorized person(s). In certain ries, by law, the batch release
is a task of the authorized person production together with the authorized person QC.
The authorized person responsible for approving a batch for release should always ensure that the following requirements have been met:
(a) the marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned;
(b) the principles and guidelines of GMP, as laid down in the guidelines published by WHO, have been followed;
(c) the principal manufacturing and testing processes have been validated;
(d) all the necessary checks and tests have been performed and ac taken of the production conditions and manufacturing records;
(e) any planned changes or deviations in manufacturing or QC have been notified in accordance with a well-defined reporting system before any product is released. Such changes may need notification to, and approval by, the medicines regulatory authority;
(f) any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate, to cover planned changes and deviations;
(g) all necessary production and QC documentation has been completed and endorsed by supervisors trained in appropriate disciplines;
(h) appropriate audits, self-inspections and spot-checks are carried out by experienced and trained staff; approval has been given by the head of QC;
(j) all relevant factors have been considered, including any not specifically associated with the output batch directly under review
(e.g. subdivision of output batches a common input, factors associated with continuous production runs).
