Requirements of the quality management system
Article 5
1. The design of the quality management system shall be based on the following risk management principles: (a) the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the user and the safety of the animals treated; (b) the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk. 2. The manufacturer shall document the quality management system and shall monitor its effectiveness. 3. The quality management system shall specify: (a) the organisational structure of the manufacturer; (b) procedures, processes and resources and activities necessary to ensure the quality and purity of the active substance; (c) the persons authorised to release active substances and intermediates thereof. 4. The quality management system shall ensure that: (a) there is an adequate number of personnel with the necessary qualifications and adequate training and there is clear allocation of responsibilities, including managerial responsibilities; (b) there is a quality unit in place, which is independent from production, and that fulfils both quality assurance and quality control responsibilities; (c) the premises and equipment are suitable for the intended use and they are appropriately maintained; (d) all quality-related activities are recorded at the time they are performed and that the records identify the person making the entry; (e) there is an adequate documentation system that ensures that appropriate specifications are laid down for materials used in the manufacture of the active substance and intermediates thereof, that the production and quality control procedures are clearly defined, and that appropriate records are kept; (f) the manufacturing process is systematically reviewed to ensure that it is capable of consistently delivering a product of the required quality in compliance with the relevant specifications; (g) appropriate controls, including in-process controls and validations are carried out; (h) the results of product and process monitoring are taken into account in the context of batch release and in the investigation of deviations; (i) quality defects, deviations and other problems or unusual events that may have an impact on the quality of the active substance are identified, the causes investigated, and appropriate corrective and/or preventive measures are taken; (j) arrangements are put in place for the prospective evaluation of planned changes and their approval prior to the implementation thereof taking into account applicable regulatory requirements, as well as for the evaluation of changes implemented (change control); (k) no materials are released or used before the satisfactory completion of evaluation by the quality unit unless there are appropriate systems in place to allow for such use; (l) procedures are in place for notifying the management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions; (m) there is a process of self-inspection and/or quality audit which regularly appraises the effectiveness of the management quality system.