Quality assurance personnel

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... 

Appropriate and valid SOP s are established and follovired A Quality Assurance Program is in place A Study Director and a Principal Investigator, If needed, Is designated Documented approval of the study plan The study plan Is available to quality assurance personnel... 

The role of the quality assurance personnel is to inspect the laboratory activity and verily that this activity complies with the GLP principles. 

In 1990, 10,600 tons of soil contaminated with cadmium and lead from a former battery recycling facility in Savannah, Illinois, were treated with the STC Remediation, Inc., reagents. The vendor states that the reagents, on-site technical support personnel, and the on-site quality assurance personnel cost 51.00 per ton of soil treated (D113382, p. 13). 

According to the vendor, the costs of reagents, on-site technical support personnel, and onsite quality assurance personnel were 60 per ton of soil treated at a former electroplating facility in McPherson, Kansas. The reagents were applied to 1500 yd of chromium-contaminated soil (D113382, p. 15). 

Quality assurance personnel must have the appropriate training, experience, familiarization with the manufacturing facility and products, enforced independence from the production chain of command, and the ability to review adherence to procedures, policies, and agreed-upon approaches to manufacturing quality pharmaceuticals. This helps to provide both an environment and a manufactured product that can withstand Food and Drug Administration (FDA) inspection and support a firm s reputation for quality products. 

Many quality assurance managers, particularly for field laboratories, have learned their skills on the job. Very few tertiary courses exist to help quality assurance managers, but assiduous searching of the Internet, subscription to journals such as Accreditation and Quality Assurance, and participation in the activities of professional organizations allow analysts to build their expertise. I hope that this book will fill in some gaps for such quality assurance personnel and that it will give students and new professionals a head start. 

As the flavour and odour of a soft drink or fruit juice are very important elements of a product they should be closely controlled. This is generally carried out by trained panellists who have been screened to ensure that they have an aptitude for this type of assessment they are often quality assurance personnel or workers from the factory. Sensory assessments should be carried out in surroundings where the panellists can concentrate without distractions. 

The level of control and validation documentation required (i.e., through increased testing and tighter specifications) increases as one moves closer, in a multistep, in-plant process, to the outcomes [i.e., final intermediate(s) and the API itself]. Naturally, when key and final intermediates are sourced from outside the company, they must enter with appropriate certificates of analysis (CofA), plus thorough inspections of off-site facilities by quality assurance personnel. 

Since we are talking about testing that is frequently conducted on wild species that have not been routinely tested in the laboratory it is important to stress that Quality Assurance personnel be aware of special requirements, such as temperature control, light control, cage or tank size, water quality, etc. This information should be available in the protocol and the SOP. 

Inspectors and quality assurance personnel should routinely ask to see the chemical analyses or residue analyses performed on each lot of test organisms used in bioassays that were reported to the Agency. 

The equipment and process(es) should be designed and/or selected so that product specifications are consistently achieved. This should be done with the participation of all appropriate groups concerned with assuring product quality, e.g., engineering design, production operations, and quality assurance personnel. 

Quality assurance personnel must have, or be given specific training in, the auditing of... 

Problems more serious than a single OOS result, such as multiple OOS results, product mix-ups, and contamination, require full-scale formal investigations involving QC and quality assurance personnel in addition to laboratory and production workers in order to identify exact nonprocess or process-related errors. 

For the purposes of more clearly differentiating between the laboratory investigation phase and a subsequent formal investigation conducted outside the laboratory, the laboratory investigation will be referred to as phase I, while the formal quality assurance-coordinated investigation will be referred to as phase II. For the purposes of phase I v. phase II, there is a definite difference, in that QC personnel handles the laboratory functions, while quality assurance personnel monitors and coordinates the overall investigative process. 

Finally, a remote monitoring capability allows a single human monitor to oversee a number of production lines—colocated or geographically dispersed, even globally—from a central monitoring station. The capacity is cost effective, allows for fewer better-qualified quality assurance personnel, and allows the controlled invitation of outside regulatory personnel (from FDA, EMEA, etc.) to view a process to discuss possible problems or improvements. 

Responsibilities of the Quality Assurance Personnel The responsibilities of QA personnel are many. The QA should ... 

Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel. 

A series which presents the current state of the art in chosen areas of oils and fats chemistiy, including its relevance to the food and pharmaceutical industries. Written at professional and reference level, it is directed at chemists and technologists working in oils and fats processing, the food industry, the oleo-chemicals industry and the pharmaceutical industry, at analytical chemists and quality assurance personnel, and at lipid chemists in academic research laboratories. Each volume in the series provides an accessible source of information on the science and technology of a particular area. 

X-ray diffraction is used to quantify the crystalline species such as zeolite, alumina, and kaolin in raw materials and finished products. Such information is used not only by research scientists, but also by quality assurance personnel during the manufacturing process. Changes in any of these materials can affect the catalysts performance and cost, therefore they must be precisely controlled. 

Revalidation can often be conducted without restricting release of the drug products whose manufacturer is supported by the computer system. Authorized Quality Assurance personnel must approve release of drug products during revalidation. In Europe this should be a Qualified Person. 

Are project activities and dehverables reviewed and audited by quality assurance personnel Is consistency maintained across different projects ... 

When the decision has been made about the need for a system validation, sufQcient resources should be allocated. For larger projects, the recommendation is to form a validation team consisting of Quality Assurance personnel and technical experts. All validation activities at the user s site should follow a Validation Plan. 

The determination of system impact as direct or indirect, and the result of criticality assessment, should be documented. Review and approval by Quality Assurance personnel are expected. 

This article is designed to facilitate the understanding of the general principles of tablet press instrumentation and the benefits thereof by the formulators, process engineers, validation specialists, and quality assurance personnel, as well as production floor supervisors who would like to understand the basic standards and techniques of getting information about their tableting process. 

A written report of an inspection or audit performed at the manufacturer s site by quality assurance personnel. 

An officially-conducted examination (i.e. review of the conduct of the trial, including quality assurance, personnel involved, any delegation of authority and audit) by relevant authorities at the site of investigation and/or at the site of the sponsor in order to verify adherence to GCP and GLP as set out in this document. 

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