Quality management

Principle

100. Quality management is that aspect of the overall management function, which directs and controls an organisation with regard to quality. This should include every aspect of manufacture to ensure that the quality objectives will always be achieved.
     • A quality system should be established, documented, implemented and maintained to ensure that finished products are safe, are of appropriate quality, and meet regulatory requirements. The quality system should take into account the appropriate elements outlined in the Code and incorporate risk management principles.
     • The fundamental concepts of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related and are described in the Code to emphasise their interaction and their primary importance to the production and control of therapeutic products.

General

101. The quality system should provide a structured and organised approach for quality to be achieved. There should be resources at all levels to enable objectives to be met effectively.
102. The organisation's quality policy should be defined and management should take measures to ensure that the quality policy is understood, implemented and maintained at all levels of the organisation.
103. Management should define objectives pertaining to the quality, safety, efficacy, and applicable regulatory and legal requirements. Procedures should be available to detail how these objectives are to be met.
104. The system of Quality Assurance appropriate for the manufacture of products should ensure that:
     • therapeutic products are designed and developed in a way that takes account of the requirements of this Code;
     • production and control operations are clearly specified and Good Manufacturing Practice adopted;
     • managerial responsibilities are clearly specified;
     • arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
     • all necessary controls on intermediate products, and any other in-process controls and validations are carried out;
     • the finished product is correctly processed and checked, according to the defined procedures;
     • therapeutic products are not supplied before an authorised person has verified that they have been produced and controlled in accordance with the requirements and any other regulations relevant to the production, control and release of therapeutic products;
     • satisfactory arrangements exist to ensure, as far as possible, that the therapeutic products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life.
105. Documented procedures to ensure that deviations from the quality system, test procedures and manufacturing procedures are recorded, investigated and approved should be established maintained and implemented.
106. An authorised person within the quality unit should approve deviations and any action taken.
107. If applicable, corrective or preventive action should be taken to eliminate the cause of nonconformities in order to prevent recurrence or occurrence.

Measurement and monitoring

108. The quality system should be reviewed to ensure ongoing effectiveness and to identify any improvements needed.
109. A program for self-inspection should be established, documented and implemented to periodically assess the effectiveness of the quality system.
110. Selection of auditors and conduct of self-inspections should ensure objectivity and impartiality. Auditors should not audit their own work.
111. Self-inspections should be recorded. Reports should include observations made during the inspections and, where applicable, proposals for corrective measures. Records of the subsequent actions should be maintained.
112. There should be procedures for the ongoing management and review of the corrective actions to ensure timely and effective implementation.
113. Regular periodic quality reviews of all products should be conducted with the objective of verifying the consistency of processes and the appropriateness of current specifications for both starting materials and finished product. Quality reviews may be grouped by product type where scientifically justified. Trends should be highlighted to identify necessary product and process improvements. Such reviews should be conducted and documented annually, taking into account previous reviews, and should include, as applicable:
     • A review of material used for the product, especially those from new sources;
     • A review of critical in-process controls and finished product results;
     • A review of all products that failed to meet established specification(s) and their investigation;
     • A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventive actions taken;
     • A review of all changes carried out to the processes or analytical methods;
     • If applicable, a review of the results of the stability monitoring program and any adverse trends;
     • A review of all quality-related returns, complaints and recalls and the investigations performed at the time;
     • A review of adequacy of any other previous product process or equipment corrective actions;
     • The qualification status of relevant equipment and utilities, e.g. HVAC, water, gases, temperature controlled equipment;
     • A review of Contractual Agreements to ensure that they are up to date.
114. The manufacturer should evaluate the results of the product review and an assessment should be made whether corrective and preventive action or any revalidation should be undertaken.
115. The quality system should be reviewed by management at appropriate and defined regular intervals, to ensure the continuing suitability, adequacy and effectiveness of the quality system. Records should be maintained.
     
     Management reviews should include:
     • results of self-inspections;
     • complaints and recalls;
     • results from product reviews;
     • status of preventive and corrective actions;
     • deviations and any trends;
     • follow-up actions from previous management reviews;
     • the need for improvement to ensure the effectiveness of the quality system.
116. A formal change control system should be in place to evaluate and document all changes that may affect the collection, processing, storage, dispatch, quality control and quality assurance of product.
117. The potential impact of the proposed change on the quality of the product should be evaluated and should be approved by the quality manager, or delegate, before implementation.

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