GOOD LABORATORY PRACTICE STANDARD OPERATING PROCEDURES

SOP- from the military to the businesses

The concept of Standard Operating Procedures (SOP) was initially used in the U.S. Army to describe a system of military instructions that allowed the execution of orders in a systematic and predictable manner. In subsequent years, the concept was implemented into medical terminology, and now it is used in other fields that require for their efficiency repetitive but effective instructions that allow rapid achievement of the desired objective.

But what really is SOP? Practically speaking, SOP is a system of planned instructions, procedures enabling an entrepreneur to achieve a certain goal without additional complications. The SOP should describe in simple steps the next steps of conduct in particular situations that may occur to employees of various industries. It is important that the steps are written in a clear and transparent way that does not cause doubts to those who will have to apply it. Through repetition and detailed description of important issues, SOP leads to standardization and improvement of the application of the most complex processes occurring in companies. SOP system does not only constitute support and facilitation for employees – it also improves the work of business owners who, thanks to it, have a better understanding of the processes taking place in entities and are able to more effectively supervise and respond to operations carried out in companies.

What does the typical SOP contain?

As a general rule, any properly formulated SOP should include:

• title and identification of the procedure it is intended to streamline,

• date of issue and period of validity

• the name of the person responsible for the development of the SOP in a given organisation, as well as the person implementing it,

• detailed instructions as to the specific process and its purpose,

• data of the person executing and controlling the execution.

These criteria vary depending on the related industry and are usually extended to additional elements.

SOP system in the Good Laboratory Practice

The consequence of the implementation of the concept of SOP into terminology was the need for its legal regulation in relevant normative acts. Regulation of the Polish Minister of Health on Good Laboratory Practice and the performance of tests in accordance with the principles of Good Laboratory Practice of 22May 2013 comprehensively regulated the above issue in chapter 8. From the content of the latter chapter it can be concluded that the research unit (which means the entity engaged in testing of chemical substances and their mixtures) should implement SOP in order to ensure the quality and correctness of its tests. The SOP takes the form of a document that is then approved by the manager of the testing entity.

Each individual within the test facility is entitled to receive specific instructions related to their services – these instructions may be supplemented by appropriate manuals, articles or handbooks. Any amendment that is made to the SOP requires the approval of the manager of the research unit, and any deviation from the Procedures made by the practitioner in the course of the research must be documented and submitted to the research manager or prime contractor. 

Areas of application of SOP under the Regulation of the Polish Minister of Health

The analysed regulation also stipulates the areas to which the SOP should be applied in particular. These include:

1. incoming, identification, marking, material handling, sampling and storage in relation to test and reference material,

• use, maintenance, cleaning and calibration in respect of measuring instruments,

• validation, application, maintenance, systems security, control and back-up in relation to computer systems,

• preparation and labeling in relation to auxiliary materials, reagents and solutions,

• study coding, data collection, report writing, indexing systems, and data handling, including the use of computer systems for recording, reporting, storing, and retrieving data,

• how the person or persons conducting the quality assurance program will conduct the planning, conducting, and documenting of inspections and the preparation of inspection reports with respect to the quality assurance program.

The SOP may also be applied to testing systems, if the need arises. In this situation, the SOP shall be established as to the following activities:

• preparation of the test facilities and the environmental conditions of the facilities for the test system,

• procedures for receipt, transport, proper placement, characterization, identification, and care of the biological test system,

• test system preparation, observations, and testing before, during, and after the study,

• handling of animals that die or are in an agonal state during the study,

• collection, identification and handling of specimens, including dissection and histopathological examination,

• location of testing systems in the study schedule.

SOURCES:

1. Regulation of the Polish Ministry of Health of 13 May 2013 http://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20130000665/O/D20130665.pdf;
2. Act of February 25, 2011 on chemical substances and their mixtures, Article 16.2 (definition of research unit) http://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20130000665/O/D20130665.pdf;
3. https://www.prawo.pl/zdrowie/standardowe-procedury-operacyjne-to-procesy-postepowania-z,253406.html;