Pharmaceutical quality system management review

QRM finds its way into medicines regulations as it is seen as a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. A structured and documented management of risks is a requirement in EU GMP as well as in the European Pharmacopoeia (Ph. Eur.). A guideline with a description of QRM elements together with appropriate tools is to be found in ICH Q9, mainly directed at manufacturing. Finally implementation of QRM in the Pharmaceutical Quality System is briefly elaborated. 

The guidelines on the Pharmaceutical Quality System may be used as a structure for a PQS, however GMP Chap. 1 already points at ICH QIO as being more suitable for that purpose. ICH QIO provides structure for the design processes and for skills such as knowledge and quality risk management, review of trends and patient satisfaction. These skills enable effective quality management. 

Use the executive management review aspect of the quality system regulation as a quality guidepost within the pharmaceutical and biotech industries. 

GxP data, records, and documentation including computer vahdation should be archived. Internal audit reports from self-inspections monitoring a pharmaceutical or healthcare company s compliance with its own quality management system do not have to be retained once corrective actions have been completed, so long as evidence of those corrective actions is kept (e.g., change control records). Supplier audit reports and periodic reviews are not internal audits and should be retained. 

The purpose of a Supplier/integrator audit is to allow the pharmaceutical manufacturer to review documented evidence of the application of the supplier Quality Management System (QMS) throughout the development of the LIMS package. The Supplier Audit will also confirm that the supplier is capable of delivering the correct standard of software engineering and documentation for LIMS. 

The pharmacist not only has to manage risks of insufficient product quality or loss of availability, but also other risks, such as health risks of his personnel or financial risks. EU GMP focuses on the risks to product quality. QRM is an element of the Quality Management System in parallel to requirements of EU GMP Chap. 1 (see Sect. 21.6.1). Even though e.g. health and safety of the operators and environmental risks are equally important in a societal perspective, these considerations, from a GMP viewpoint, have to be taken care of in other ways. For an illustration of this opinion, compare the warning for pharmaceutical inspectors Inspectors should be cautious when reviewing assessments which include other business-related risks (e.g. environmental, occupational health safety) in addition to quali risk assessments. As whilst these factors are important in a holistic sense there is a danger that they may compromise quality [7]. 

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