Standard Operating Procedure SOPs

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

A specific detailed description and protocol should be written (standard operating procedure (SOP)). 

The plan should also address standard operating procedures (SOPs) for site operations to help minimize contact with hazardous materials. 

D. Task-specific hazard analyses must lead to the development of written standard operating procedures (SOPs) that specify the controls necessary to safely perform each task. Detailed hazard analyses conducted for each site task and operation provide the basis for developing SOPs to protect employees from safety and health hazards. Written SOPs provide a mechanism for informing employees of procedures that ensure their safety and for enabling management to enforce hazard control procedures. 

What Is the Expected Output or Work Product. The specific form of the finished product will vaiy according to your company s practices and needs. However, it s reasonable to expect that the team s efforts will ultimately produce a set of documented Standard Operating Procedures (SOPs) for the management system, or their equivalent within your organization (see Section 6.3). Interim work products may include progress reports (see Chapter 8), documentation of discussions and analyses, flowcharts, or other materials. 

Standard operating procedures (SOPs) are step-by-step job instructions which can help workers perform their jobs safely and efficiently. When the end users are involved in their design, SOPs can provide a basis for arriving at a method of work agreed-to by different shifts. In this sense, SOPs can be used to develop training programs and specify measures of competence. Because of the importance of SOPs in the work situation, a systematic framework is needed to enable the design of reliable procedures which are acceptable by the workforce. 

One of the major undertakings during LIMS implementation is user training, which should cover not only the LIMS itself but also the standard operating procedures (SOPs) that govern use, administration, training, and other aspects of the LIMS. The training should be conducted on the test system... 

Standard operating procedures (SOPs)— The SOPs are controlled in a way similar to that of specification documents and analytical methods. It must be ensured that the correct versions of the SOPs are accessed and used by the scientists. After use, the hard copies should be destroyed and disposed of properly. An added requirement is that the SOPs should be accessible during working hours without interruption. Hard copies should be available at a manageable location so that the SOPs are available when the electronic system is down. 

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... 

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. 

Consultants who were members of a particular segment of the food processing industry may be very instrumental in developing the best processing practices and describing them in a standard operation procedure (SOP). Consultants are often able to develop the necessary information for an SOP quickly. 

The training of LSMBS shoppers is generally conducted by telephone and through written instructions. The written instructions and forms provided to the shoppers form the equivalent of a standard operating procedure (SOP). Often, since the network of shoppers is widely dispersed and may or may not be involved with more than one sample collection period, formal SOPs are not devised and provided to the shoppers. Instead, complete written instructions are provided, albeit not necessarily in SOP format. 

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. 

To assure consistency and speed in multidisciplinary structure analysis of low-MW compounds involving various techniques (IR, NMR, MS, etc.) most industrial laboratories use a Standard Operating Procedure (SOP). In such schemes IR analysis is frequently used as a cheap filter for a quick starting control and as a means for verification. As IR detects only structural units identification of an unknown compound on the basis of IR is difficult. Mass spectrometry is used as the prime identification tool and is especially important in the determination of the exact mass and gross formulae. While structural prognostication on the basis of MS is difficult for the non-expert, a posteriori interpretation is quite feasible. H NMR is both easy and cheap, however requires greater sample quantities than either... 

In summary, for data to be useful in clinical trial analyses they need to be quantifiable. The data must be either a continuous measure or a categorical value. Free text poses a problem for analysis, and if it is a valuable variable for the statistical analyses it really must be coded. Finally, hardcoding should be used only when absolutely necessary, because it is inherently problematic. Organizations that do allow hardcoding should document in their standard operating procedures (SOPs) that it is an approved business practice and how it is to be used. 

Standard Operating Procedure (SOP, see ISO 78-2 [1999]). Complete Analytical Procedure, according to Kaiser [1965]... 

Precision of a complete analytical procedure, i.e., a standard operation procedure (SOP), should be characterized by the uncertainty of measurement (absolute or relative) as exactly as validation it stipulates. 

Standard Operating Procedures (SOPs) should be properly authorized, documented and available to the staff carrying out the work. They must also be identified and controlled, so that all staff are aware of the current version and no outdated or altered copies can be used. SOPs should be regularly reviewed to ensure that they are still appropriate for the study programme. A system is required so that superseded versions of the operating instructions are filed and available, in order that studies carried out in the past using the SOPs in existence at the time of the study can be reconstructed if necessary. 

Standard Method of Test for Distillation of Petroleum Products, 24 284 Standard Oil of New Jersey (Exxon), 24 259 Standard Operating Procedures (SOP), 21 165... 

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