Quality audits guidelines

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. 

Government Institutes, Inc., 1993, ISBN 0-86587-336-4, 120 pages, 49. This OSHA Inspection manual covers process safety management (PSM) compliance guidelines, PSM audit guidelines, clarifications and interpretations of the PSM standard, and SIC codes targeted for the program quality verification inspections. 

Figure 9.1 is a flowchart giving an overview of the quality auditing process. Below are set out some guidelines incorporating a procediure using the various model forms proposed in the figures attached to this chapter ... 

The IHT guidelines describe how Road Safety Audits may be carried out on local streets in relation to advice given in Manual for Streets. In this case, it is recommended that Road Safety Audits should be carried out as part of a comprehensive quality audit. The use of risk assessments is also suggested for schemes in local streets as a way of prioritising the safety issues identihed, and a methodology for such assessments is included. 

For schemes on local roads, the use of quality audits and a balanced design approach as advocated in the latest IHT Road Safety Audit guidelines could be adopted to reach a final decision. 

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. 

Guidelines for auditing quality systems - qualification criteria of quality system auditors... 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

The advent of a more active monitoring role by the sponsor and audits with the global framework of ICH GCP and other guidelines has significantly increased the quality of therapeutic trials sponsored by pharmaceutical companies. The new standards now also apply to trials conducted independently by individual clinicians. 

Laboratories may indicate that they do quality work and adhere to GLP regulations and/or ISO guidelines, but they must also prove that they do so. Thus, the GLP regulations provide for audits by the quality assurance unit as well as by EPA or FDA inspectors, and ISO registration will also involve an audit process. 

International Organization for Standardization (ISO), (2002), Guidelines for quality and/or environmental management systems auditing, ISO 19011 2002, ISO, Geneva. 

ISO 10011-1 1990, Guidelines for Auditing Quality Systems — Part 1 Auditing. ISO 10011-2 1991, Guidelines for Auditing Quality Systems — Part 2 Qualification Criteria for Quality Systems Auditing. 

ISO 10011-3 1991, Guidelines for Auditing Quality Systems — Part 3 Management of Audit Programs. 

When the first draft of a protocol is typed, it is sent to the Quality Assurance Section to be audited. The protocol is checked for those details required by the Good Laboratory Practices guidelines. Comments about each protocol are sent to the study director. When the final version of the protocol is typed, it is again sent to Quality Assurance for review. The original copy of the signed and dated protocol is filed in the archive. 

Audits should be conducted by suitably trained/qualihed personnel against the applicable ISO 900Cb series standard, with special reference being made to software quality guidelines (e.g., ISO 9000-3, TicklT ) for instrument systems involving software. The software audit may cover the development of both application software and core (operating system level) software, depending on the type of system to be supplied. Follow-up audits should be considered. 

International Organization for Standardization, Guidelines for Quality and/or Environmental Management Systems Auditing (ISO 19011 .2002(E)), International Organization for Standardization, Geneva, Switzerland, 2002. 

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