(1999; 168 pages) [Spanish]
3. Routine duties of an authorized person
Before approving a batch for release the authorized person doing so should always ensure that the following requirements have been met:
• The marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned.
• The principles and guidelines of GMP, as laid down in the guidelines published by WHO, have been followed.
• The principal manufacturing and testing processes have been validated, if different.
• All the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records.
• 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.
• Any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate, to cover planned changes and deviations.
• All necessary production and quality control documentation has been completed and endorsed by supervisors trained in appropriate disciplines.
• Appropriate audits, self-inspections and spot-checks are being carried out by experienced and trained staff.
• Approval has been given by the head of the quality control department.
• All relevant factors have been considered, including any not specifically associated with the output batch directly under review (e.g. subdivision of output batches from a common input, factors associated with continuous production runs).
In certain circumstances the authorized person may be responsible for the release of intermediates manufactured on contract.