Laboratory, standard operating procedures

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. 

Carlin, L.M. Long, T. Ozdemir, S. "UAPSP Laboratory Standard Operating Procedures. UAPSP 102" Utility Acid Precipitation Study Program Washington, D.C., 1982. 

Another extremely important aspect of an effective quality system is documentation. Accurate and full documentation of all activities is required to ensure the integrity of data generated in the laboratory. Standard operating procedures and working instructions should be prepared and used for the laboratory processes, and all such documents should be controlled. Any notes made, calculations, or changes to procedures should be recorded and, if necessary, explained. It is useful to adopt the phrase If you did not write it... 

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. 

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... 

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... 

There are many regulations regarding the handling and disposal of radioisotopes and these must be fully understood and observed when setting up a radioisotope facility. The hazards must be fully assessed and the laboratory must be equipped and approved for the intended applications. All manipulations must be assessed for specific hazards and standard operating procedures (SOPs) fully implemented. 

An analyst, a metrologist, or a qualified contractor can perform the calibration, though all must follow the company s prescribed standard operating procedure (SOP) and acceptance criteria. The cost effectiveness of using outside contractors or an internal metrology department is dependent on company size and the number of HPLC systems in the laboratory. 

The SLC document typically consists of technical documents with system descriptions. It also has references to standard operating procedures (SOPs) and administrative and maintenance systems. A completed SLC documentation set is typically required prior to using analyzer systems in the pharmaceutical laboratory or manufacturing site. It is also required prior to use of the data obtained by the system in GMP. 

Laboratory apparatus should be periodically inspected, cleaned, maintained, and calibrated according to standard operating procedures. 

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. 

All operations that are done regularly in the laboratory, especially the analyses, have to be described in standard operation procedures (SOP). It is useful to describe the standard operations in separate documents and to include only a list of all SOP s in the qnality manual. 

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. 

Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study. 

To meet the requirement for standard operating procedures, the laboratory is advised to develop a system to ensure that aU working copies of the SOPs are identical. When SOP revisions are distributed, aU holders of the manual should be instructed at a minimum to destroy the outdated version of the procedure. A better approach is to require the outdated version to be returned to and accoiuited for at a central location. FoUow-up should then be provided to ensure the return of all copies of the outdated procedure. Ideally each distrib-... 

The requirement to indicate all methods for the conduct of the study does not mean that all laboratory SOPs must be reiterated in the protocol it is sufficient if the protocol indicates what will be done and when it will be done. Laboratory SOPs describe how each study activity is to be performed. If exceptions from SOPs will apply for the study, then those exceptions should be described in the protocol. The FDA has indicated that the protocol should list the SOPs used in a particular study, but the author suggests that a simple stipulation in the protocol that the study will be conducted in accordance with current standard operating procedures is sufficient. Listing each SOP in the protocol could cause problems if SOP identifying numbers or titles change during the course of a study. 

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