Quality control activities including sampling, testing, required documentation and records, and release procedures are established to ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, no products released for sale or supply, until their quality has been judged to be satisfactory.
Products are tested at various stages as specified in the quality plans. Test specifications specify the acceptance criteria.
The monitoring activities also include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures if any.
No batch of product is released for sale or supply unless certified by the authorized person(s) that all the requirements are met and that it is in accordance with the requirements of the marketing authorization.

PROCEDURES: