Standard operating procedures method development

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. 

Results Standard operating procedures (SOPs) have been prepared for each method developed. 

While these are two separate and distinct activities, each must complement the other to ensure a quality program. Day to day quality control in the laboratory is the obligation of the chemist. The chemist develops the methods, calibrates the instruments, and with management approval develops the standard operating procedures for the laboratory. Quality control is running duplicate samples, reagent blanks, fortification samples, linearity checks and confirmatory analyses. 

Method development includes feasibility and optimization to meet the predefined study requirements. The appropriate standard calibrator range and concentrations of VS and QC (see discussion below) should be established for the dosage form and route of administration. The lessons learned during method development are critical for the development of specific parameters for the performance of the assay. For example, the number of validation batches and acceptance criteria should be described in a validation plan, and the standard operating procedure (SOP) should be written before conducting the pre-study validation. The correct approach should be to develop a valid (acceptable) method, rather than simply... 

Every in vitro method should be detailed in the developer laboratories using Standard Operating Procedures (SOPs) covering all essential components and steps of the method. The SOP(s) should be sufficiently defined and described and should include the rationale for the test method, a description of the materials needed, such as specific cell types, a description of what is measured and how it is measured, a description of how data will be analyzed, acceptance and decision criteria for evaluation of data, and what are the criteria for suitable test performance. All limitations, e.g., lack of metabolic competences (presence of phase 1 and phase 2 biotransformation activities) or absence of critical transporters, should be included in the in vitro method description. In general, the in vitro method should not require equipment or material from a unique source. This may not be always possible for particular in vitro test systems or other components of the method in which case a license agreement between the provider and a recipient/user may be required. For complex and/or specialized equipment, the equipment specifications and requirements should also be described. Acceptance criteria for measurements carried out on the equipment should also be provided where applicable (e.g., for analytical endpoint determinations, linearity and limits of detection should de detailed) [2],... 

The standard operating procedure (SOP) manual contains the procedures validated by the laboratory it is a complete set of instructions for pre-analytical, analytical and post-analytical methodology and also procedures for quality assurance/control, chain-of-custody and security. Each step in the handling of the specimen should be evaluated, optimized where possible and documented in the SOP. Important steps in the analytical process include collection, transport and accessioning of the specimen, sample preparation, isolation and detection of the analytes, production of the report and disposal of the specimen. This chapter focuses on the quality assurance and control issues for analytical method development and validation as well as statistical representation of the data. 

About 50 laboratories participated in each programme. In the course of the successive trials, several microbial strains have been studied and several standard operating procedures have been developed and validated. Each trial was preceded by fundamental research on the stabilisation and the homogenisation of the test strains. In each trial the participants used at least two methods the own home made procedure ... 

The microbial strains studied were Salmonella thyphimurium (two exercises). Listeria monocytogenes (two exercises) and later Bacillus cereus. Staphylococcus aureus, and Clostridium perfrengens for food microbiology, and Escherichia coli. Enterococcus faecium, Enterobacter cloacae and Staphylococcus warneri for water microbiology. The results were discussed in meetings with all participants. Several standard operating procedures common for several methods were developed, tested and amended, e.g. measurement of pH of culture media, measurement of temperature in incubators, statistical treatment of results, etc. 

If the bioanaiyticai method is performed according to good laboratory practice (CLP), the method is described in a standard operating procedure (SOP) and the validation method is reported accordingly. In general, validated methods are used in preclinical development for toxicokinetic studies and in clinical development for all studies in which pharmacokinetics is evaluated. 

Method development is complete once the method steps have been formalized in a draft method standard operating procedure (SOP) ideally prepared in a standard format such as set out in ISO 78-2 1999, ° and sufficient replicate... 

Each winery should develop a series of standard operating procedures (SOPs) for each operation of the cleaning and sanitizing program. The SOPs must include specific protocols, schedules, and methods to document implementation of the approved protocols and schedules. 

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