Standard operating procedure, good

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

The individual scientist is the key to the production of quality data and must have technical competence and a dedication to quality work. Passive following of good laboratory practices and good measurement practices is not enough. Involvement in their development is required if the quality assurance program is to be credible. Standard operations procedures (SOPs) do not minimize the need for technical competence. Analysts exhibit varying degrees of proficiency when... 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

Statisticians in the Pharmaceutical Industry (PSI), at http //www.psiweb.org. They have published the excellent Guidelines for Standard Operating Procedures for Good Statistical Practice in Clinical Research, at http //psiweb.org/pdf/gsop.pdf. 

GLP stands for good laboratory practices. These are federal regulations governing FDA- and EPA-affiliated laboratories and pertain to proper procedures in the laboratory to ensure that results are obtained in as trustworthy a manner as possible. SOP stands for standard operating procedure. These are step-by-step written procedures that are specially approved by laboratory directors for carrying out certain specific tasks. 

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... 

Provision of adequate competent medical staff is essential for the safe and ethical conduct of studies in humans. Decisions about whether a volunteer fulfils the entry criteria for a healthy subject or should be withdrawn from a study, how to respond to an unexpected adverse event and when to discontinue a study can prove challenging to the most experienced physician. Similarly, research nurses need many organisational and other skills over and above those that they acquired during their basic clinical training. Scientific staff must be competent in the techniques that will provide the essential data. All must be properly briefed about what will be required of them during the course of a study, and must be fully familiar with local standard operating procedures (SOPs) in compliance with good clinical practice (GCP). 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

In summary, when using the indirect" technique for optical trace analysis, all of the points mentioned above have to be considered and have to be validated when setting up a standard operation procedure" (SOP), in order to conform to good laboratory practice (GLP) analysis methods. This means an extra work load compared with validation of the direct optical trace analysis procedure. Sometimes there is no way of getting round this so-called less elegant , more cumbersome and more error prone indirect technique. However, if it is performed correctly and judged critically, it is still a good method and should easily allow optical trace analysis down to 0.1% and lower. 

Every effort has been made to ensure that the contents of the generic validation standard operating procedures are accurate and that recommendations are appropriate and made in good faith. The author accepts no responsibility for inaccuracies or actions taken by companies subsequent to these recommendations. 

Specifications How good do the numbers have to be Write specifications Pick methods to meet specifications Consider sampling, precision, accuracy, selectivity, sensitivity, detection limit, robustness, rate of false results Employ blanks, fortification, calibration checks, quality control samples, and control charts to monitor performance Write and follow standard operating procedures... 

Strict good laboratory practices (GLP) compliance was not recommended, but standard operating procedures (SOPs) and other GLP-like practices were recommended. 

Industrial codes and standards for hydrogen are thus strict for a good reason. Some 22 percent or more of hydrogen accidents are caused by undetected hydrogen leaks.44 And this is despite the standard operating procedures, protective clothing, and electronic flame gas detectors provided to the limited number of hydrogen... 

Good laboratory practice (GLP) A system of protocols (standard operating procedures) recommended to be followed so as to avoid the production of unreliable and erroneous data. Accurate record keeping and careful forethought in the design of the study are important aspects of GLP. 

Manufacture of any pharmaceutical product must satisfy the requirements of Good Manufacturing Practice (GMP). These are basically that the equipment be properly designed, maintained and cleaned, that Standard Operating Procedures are written, approved and followed, quality to be independently monitored and that all personnel... 

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