Quality Assurance audit responsibilities

Finally, QA is the effort taken to ensure compliance with government regulations for the systems, facilities, and personnel involved with manufacturing products. Quality assurance audits will be quite varied in scope to achieve this assurance. These responsibilities include batch record reviews, critiques of product design, process validation activity, and, possibly audits of other departments operations. 

Quality Assurance, the responsibility of the quality assurance unit, is the nitpicking, but totally necessary, job of determining the quality of conformance to regulations established by managers and their chemists and is done via audits and inspections. To develop a thorough quality program both quality control... 

There must be systems in place to monitor the study while it is in progress and to check that all systems are working in accordance with GLP requirements, to record any problems identified and to ensure that remedial action is taken. The person responsible for these quality assurance procedures must be independent of the study being audited. In large organizations, there may be a separate Quality Assurance unit but this will not be practical in smaller organizations. 

Since SYSCO does not itself manufacture, a quality assurance team of more than 180 professionals determines specifications for each own-brand item and also sets criteria for raw materials and for the standards that manufacturers and processors must follow for food safety, quality, and consistency, as well as for social responsibility and supplier codes of conduct. This quality assurance team identifies and establishes supply sources and audits those suppliers to enforce SYSCO s strict standards for various factors like facility conditions and sanitary measures. Inspectors are at the plants as bacon comes off the production line, or follow produce from field to cooler to assure proper holding temperatures and product integrity. SYSCO s program is unmatched in the food industry. The number of people and level of resources committed to supporting the integrity of the products are far superior to those of other industry competitors, who may devote merely a handful of personnel to these tasks, if they are undertaken at all. 

The laboratory should have written Standard Operating Procedures approved by the Laboratory Director that are intended to ensure the quality and integrity of the data generated by that laboratory. The Laboratory Director has the responsibility to approve revisions to standard operating procedures. The SOPs must be available to the persormel that are involved in the relevant activities as well as to the quality assurance team that performs the audit. 

The introduction of GCP has accelerated the need for quality control and quality assurance, particularly in the field of clinical research. Quality control is carried out by the staff who are responsible for the particular activity, working to SOPs that cover all the tasks under scrutiny. SOPs not only need to be written but must also be updated regularly. Quality assurance is the process which seeks to confirm that SOPs have been observed this is accomplished by the process of auditing. Internal audit departments should be under a separate management from the medical department. Regular audits can not only assure external bodies, such as regulatory authorities, that proper procedures have been followed, but also serve to deter those rare attempts at fraud on the part of clinical investigators, which occasionally become evident. ... 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

Supplier prequalification response Supplier audit report Project and quality plans Software quality assurance plan Commercial and purchasing specs. 

It is ultimately the sponsor s responsibility to ensure that cGCP is followed in its clinical trials, even though some of the work is contracted out to CROs and other service providers. With regard to analytical laboratories, GCP guidances require that all laboratories have full documentation, data-audit trails, standard procedures, trained staff, archives of samples and data, and routine quality assurance inspections (Prokscha, 2007). If multiple laboratories were to be used, the sponsor would need assurance that GCP requirements were met for every one. In contrast, if a central laboratory is used and all samples are shipped to it, the sponsor only needs to check GCP compliance at that laboratory. 

As a minimum, the personnel responsible for inspecting manufacturing sites should have relevant qualifications and experience in pharmaceutical manufacturing, quality assurance, GMP, performing inspections and audits, chemistry and quality control. Ideally they should have an inspection background from working with a regulatory authority. 

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. 

It might be added here, that these responsibilities will certainly be transferred to their full extent to an eventual replacement Study Director. Since a permanent replacement will entail the privilege - or the burden, whichever describes the situation better - of accepting, with the signature under the statement of GLP compliance of the final report, the full responsibility for the quality, integrity and reliability of the data and the report, it will be one of the first activities of this person to assure him- or herself, as soon as practicable after taking over the new position, and preferably with the assistance of Quality Assurance personnel, of the GLP compliance in the study as it has been conducted to date. If this were to be done by means of an interim review or data audit, the results of such a GLP review should be fully documented, especially in such cases where deficiencies or deviations were found. 

Trust is Good, Control is Better says an old proverb. However, the Quality Assurance in GLP is not intended to act as a Quality Control entity its responsibilities lie more in the direction of helping and guiding the test facility in the ways of GLP. Even the final audit of a study, that has to be performed by the Quality Assurance imit in order to check whether the report truly reflects the raw data of the study, cannot be used to introduce qualities into the study... 

As a final point to this section on inspections, it should be kept in mind that - as it is the case for any other operative procedures covered by the GLP Principles - the Quality Assurance Programme of inspections (and audits) should be subject to management verification. Management has to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice which means that the Quality Assurance has to provide management with periodic reports on its activities, not only for single studies as already detailed above, but for the totality of its... 

The quality assurance unit is generally independent from the laboratory and answers to the manager of the organization with which the laboratory is affiliated. The QAU is responsible for implementing quality procedures and assessing them on a continuing basis this will include audits of the laboratory from time to time. 

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