Quality assurance system audits

For all products in Classes Ila, lib and III, and AIMDs, a full quality assurance system, audited periodically by a notified body (Annex II of the MDD), which includes examination and certification by the notified body of the design dossier of each product covered. The manufacturer must keep documentation on the quality system and the design dossier of each product plus other documentation. The quality system obligations include post-marketing and vigilance aspects. Compliance with Annex II may be achieved (this is not mandatory but is invariably adopted voluntarily) by compliance with the EN 29000... 

There is a procedure for Self-Inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the Quality Assurance system. 

The notified body assesses the quality assurance systems by periodical auditing. 

Identification of individuals, with job titles, receiving audit Quality Assurance System... 

Medicinal products must be fit for their intended use, comply with the requirements of Market Authorization and not place patients at risk because of inadequate safety, quality or efficacy. These objectives are easy to state, but to achieve them requires a comprehensively designed and correctly implemented system of quality assurance. It is important that this is documented and its effectiveness monitored. Records must be kept that are open to inspection by validating bodies, and there must also be procedures for selfinspection and quality audit that allow appraisal of the quality assurance system. Management must be adequately trained and their responsibilities minutely defined. Two key posts are the Heads of Production and of Quality Control. These posts are required by the guidelines to be independent of one another. 

Principle. Good documentation is an essential part of the quality assurance system and, as such, should be related to all aspects of GMP. Its aims are to define the specifications for all materials and methods of manufacture and control, to ensure that all personnel concerned with manufacture know what to do and when to do it, to ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale, and to provide an audit trail that will permit investigation of the history of any suspected defective batch. The design and use of documents depend upon the manufacturer. In some cases some or all of the documents described below may be brought together, but they will usually be separate. 

Auditing the Quality Assurance system of the valve manufacturer is of particular importance. 

Metering valves for aerosols are more complex pieces of engineering than most items used in pharmaceutical production. Their specifications, sampling and testing should recognize this. Auditing the Quality Assurance system of the valve manufacturer is of particular importance. 

In order to assess the effectiveness of the quality assurance system and to ensure the application of good pharmaceutical manufacturing practices, it is recommended that self-inspection and quality audits be undertaken. 

If the quality of hardware and software objects is not adequately covered through this evaluation, it should be checked before procurement via a questionnaire that contains questions regarding the Quality Assurance System of the supplier. If the questions are not answered satisfactorily and cannot be demonstrated with examples, an audit should be conducted. 

An audit is a detailed check of the Quality Assurance System by IT specialists. An audit is carried out on the basis of a SOP containing a checklist with the respective questions. Audits conducted by other companies may be referenced. (Supplier audits are discussed in more detail within Chapters 14 and 15.)... 

Audit A systematic check to determine the quality of some function or activity. Two basic types are performance audits and system audits. Performance audits involve a quantitative comparison of the laboratory s results to those of a proficiency sample containing known concentrations of analytes. A system audit is a qualitative evaluation that normally consists of an on-site review of a lab s quality assurance system and physical facilities. 

HACCP is not designed to be a complete quality assurance system it is designed to be the part of the QA system that is focused on food safety (microbiological, chemical and physical). Record-keeping and display are vital to the process. Regular audits are also essential to ensure that the process is operating as required. HACCP works best when TQM is the basis of the company s quality philosophy (MFSC/NFPA, 1992). An overview of how TQM may be applied within the food industry is provided by Fulks (1991). 

Quality audit program. (Under this program, the Quality Manager or Supervisor periodically makes unannounced checks on inspected units, accuracy of gauges and test equipment, etc., to verify the accuracy as well as adequacy of quality assurance systems)... 

An audited Quality Assurance system should include a suitably structured approach to safe precommissioning and commissioning operations. 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

Introduction Review and audit processes are used in the chemical process industry to evaluate, examine, and verify the design of process equipment, operating procedures, and management systems. These processes assure compliance with company standards and guidelines as well as government regulations. Reviews and audits can encompass the areas of process and personnel safety, environmental and industrial hygiene protection, quality assurance, maintenance procedures, and so on. 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

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