Standard operating procedures laboratory quality

Every analytical laboratory, governmental, private, or university, has a standard set of procedures that provide both general and specific information to laboratory members. These fall into certain categories, including the laboratory s standard operating procedures (SOPs), quality assurance/quality control manuals (QA/QC manuals), procedural manuals, analytical method files, and laboratory information management systems... 

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... 

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... 

The laboratory should have written Standard Operating Procedures approved by the Laboratory Director that are intended to ensure the quality and integrity of the data generated by that laboratory. The Laboratory Director has the responsibility to approve revisions to standard operating procedures. The SOPs must be available to the persormel that are involved in the relevant activities as well as to the quality assurance team that performs the audit. 

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. 

The bioanalytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. All deviations from SOPs must be authorized by the study director and documented in the raw data. Significant changes in established SOPs must be properly authorized in writing by management. 

Another similar example is the reference to Standard Operating Procedures. The testing facility shall have written SOPS that adequately ensure the quality and integrity of the data generated. This is an opportunity for the chemist to ensure that the quality of the science is maintained uniformly and consistently throughout the laboratory, no matter who is doing the... 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

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. 

The laboratory quality control program has several components documentation of standard operating procedures for all analytical methods, periodic determination of method detection levels for the analytes, preparation of standard calibration curves and daily check of calibration standards, analysis of reagent blank, instrument performance check, determination of precision and accuracy of analysis, and preparation of control charts. Determination of precision and accuracy of analysis and method detection limits are described under separate subheadings in the following sections. The other components of the quality control plan are briefly discussed below. 

After the authentication, the Secretariat s Office of the Internal Oversight (OIO) then certifies this data. The OPCW Laboratory has a quality system, which has been accredited by the Dutch Accreditation Council (RvA). The accreditation covers the quality system as well as the specific activity of the OCAD process and other processes. The OPCW Laboratory has in place quality documents (standard operating procedures (SOPs) and work instruction) for the OCAD process. 

In the context of a GLP study (see Section 5.2) the term Study Plan or Study Protocol refers to a protocol which defines in minute detail how work is to be conducted. The Study Plan will be formally agreed by the laboratory and the client and also vetted by the quality manager (see Section 5.1). In order to avoid having to repeat descriptions of common laboratory operations in every Study Plan the GLP laboratory will maintain a library of standard operating procedures which can be cross referenced, as appropriate, in any Study Plan. 

Calorimetric methods are infrequently used for routine quality control purposes because of their non-specific nature and relatively slow speed. However, data from calorimetry experiments are commonly presented in applications for new product licenses and in support of patent applications. To ensure the integrity of all calorimetry data, normal procedures for good laboratory practices, standard operating procedures, appropriate calibration methods, and regular instrument servicing are necessary. The use of DSC for the measurement of transition temperatures and sample purity is described in the United States Pharmacopoeia, and standard procedures for DSC analyses are also suggested by the ASTM (100 Barr Harbor Dr., West Conshohocken, Pennsylvania 19428). 

The starting point for the development of automation concepts was in analytical routine laboratories (e.g. analytical R D and quality control) dealing with high numbers of samples routinely to be analyzed by the application of standardized operation procedures [349]. In parallel, the first robot systems for research were developed and these combine the key technology of liquid handling with the movement of items through a defined space. 

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