The 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, if different;

(d) all the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records;

(e) any planned changes or deviations in manufacturing or quality control 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 drug regulatory authority;