Quality assurance responsibilities

Product specifications and their acceptable limits. Quality assurance responsibilities are essentially the same for raw materials and final products. All finished drug products are tested to determine if they meet the required quality standards. These tests help to characterize the product so that the QA/QC function can determine whether or not the product has the proper strength and is safe, pure, and efficacious, yet these tests do not build quality into the product rather, they are a measure of the product s quality. 

Ensure that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice. 

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... 

Does the Quality Assurance Coordinator have clearly defined authority and responsibility and does he report directly to a senior manager ... 

There should be an organization chart for the company showing individual functions and to whom they are responsible. Job descriptions should clearly indicate responsibilities for quality. The assessor should read the job description of the quality assurance/improvement coordinator as well as of a few managers and supervisors to establish the answer to the question. 

You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

When testing and analysis are completed, the data can be analyzed and summarized. Statistical methods are often used during this step In a study. Data should first be edited and validated. Quality assurance Information from both the sampling and laboratory analyses should be considered In this validation. Field sampling personnel and laboratory scientists should maintain responsibility for data validation. 

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

Each laboratory in the OPMBS was required to send a copy of each workbook and the associated raw data, to study management soon after completion of the analysis. This information was provided after internal technical review but before local quality assurance review. Study management used a team of experienced residue chemists to review the results and the raw data and to ensure that the information reported was fully supportable. The laboratory remained at all times responsible for the data reported, however, and the results of the external review were formally considered to be advisory. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

Another external response to concerns about MCOs has been an increased interest in measuring the quality of care they deliver [35]. This interest has resulted in the development of numerous quality indicators. One example, HEDIS (Health Plan Employer Data and Information Set), is a standardized set of performance indicators used to compare health plans. Developed by the National Committee for Quality Assurance, HEDIS measures allow employers and employees to evaluate different plans. Only a small number of HEDIS indicators are related to medication use, but more drug-related indicators are likely to be added in the future. The use of quality indicators likely will increase as the measures become more refined and tested. 

U.S. EPA has issued regulations and guidance primarily focusing on double liners and LCRSs.6 7 Several Federal Register notices and guidance documents have been published by U.S. EPA in this area.8-11 U.S. EPA also issued final regulations for double liners and for LDSs, including construction quality assurance (CQA) and response action plans.12-14... 

The commercial testing lab may not need the data base of the R D lab nor the speed of the Quality assurance lab, but because of the immediate link between its operations and its economic success, a system would be deemed beneficial if it reduced cost per test, enhanced responsiveness to customers, or speeded the collection of receivables through automatic invoicing. 

During the inspection, the inspector should proceed with particular emphasis on the critical points. This system guarantees that the internal quality assurance is oriented to the risks associated with the particular type of production. It is a preventive approach. The employees who identify with the organic objective , who are involved in the process and assume responsibility for it, are more careful, because they understand the sense of quality assurance and do not feel that it is an additional burden, impractical, bothersome, a mere formality and bureaucratic. 

Elements of Testing Process Quality Assurance Issues Responsibility... 

The validation is therefore not complete until there is a detailed description of the method and records of the validation study. A responsible person needs to sign that the method meets the requirements, i.e. it is fit for purpose . The documentation facilitates the consistent application of the method, within its scope and defined performance parameters. This, in turn, helps ensure that when the method is applied in different laboratories or at different times, the measurand is the same and that the measurement results are comparable. Documentation is also required for quality assurance, regulatory and contractual purposes. 

There are two uses of chemical standards in chemical analysis. In the first place, they may be used to verify that an instrument works correctly on a day-to-day basis - this is sometimes called System Suitability checking. This type of test does not usually relate to specific samples and is therefore strictly quality assurance rather than quality control. Secondly, the chemical standards are used to calibrate the response of an instrument. The standard may be measured separately from the samples (external standardization) or as part of the samples (internal standardization). This was dealt with in Section 5.3.2. 

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. 

The format of the final report from a study is closely defined and the Study Director is responsible for its production. The test item and name of the study must be clearly identified, along with the start and end date. It has to be accompanied by a statement from the Quality Assurance unit that the study and any critical aspects of the work have been conducted to the requirements of GLP principles. It will contain the names of all those involved with the study and their address this includes the Study Director, the Principal Investigator, and all the scientists... 

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