Standard operating procedures testing facilities

Subpart E - Testing Facilities Operation Sec. 58.81 Standard operating procedures. Sec. 58.83 Reagents and solutions. 

Test facility management Test site management Sponsor Study director Principal investigator Quality assurance program Standard operating procedures Master schedule... 

The purpose of the GLP regulations is to assure the quality and integrity of the data submitted to the FDA in support of the safety of regulated products. To this end, most of the requirements of the proposal would have been considered familiar and reasonable by any conscientious scientist. Protocols and standard operating procedures (SOPs), adequate facilities and equipment, full identification of test substances, proper animal care, equipment maintenance, accurate recording of observations, and accurate reporting of results are... 

SUBPART E TESTING FACILITIES OPERATION 58.81 Standard Operating Procedures... 

Finally, during the qualification of the facility, all systems are tested, calibrated, and cleaned. The mechanical and service infrastructure must be qualified. The operational qualification will involve practice runs. All documentation must be finalized. This includes standard operating procedures, batch records, and equipment logs. 

Fourth, following written standard operating procedures. There is no mystique to SOPs, they are the heart of any test facility. They assure that everyone follows the same procedure each time, that there is no oral law that supercedes the written text. How detailed should these be There are text books on the market with standard operating procedures written in - just like you go to the stationary or office supply shop and buy a standard form will or rental agreement. You have to fill in the blanks. My definition of an SOP is a written procedure that can be followed by any well informed qualified individual with the complete expectation that the anticipated result will be obtained. Can an instruction book be an SOP Probably not. Most instruction books are written as if they had been badly translated from a foreign language. They are frequently difficult to understand. The instruction book can certainly be a part of the SOP, but rarely the SOP itself. 

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... 

Testing facilities operation Standard operating procedures (SOPs)... 

Thus, if quality is established in terms of precision and reproducibility of the results obtained in the studies (i.e. in the respective sets of measurements or experiments), the need to provide for each of the studies a study plan, approved by the head of the laboratory before the experiments or measurements can be started, will not be an important consideration. Certainly, Standard Operating Procedures will have to be observed, and the acknowledged methods will have to be followed, with any deviations to be described and justified. Since it is the quality of the result which counts for the determination of the test facility s quality , and not the way on which it has been obtained, there is no need for a single point of study control in the person of the Study Director. Certainly, a laboratory head will have to be appointed, who has to ensure that the quality of the data obtained in the laboratory remains high, and who has to provide the necessary education and training for the technical personnel in order to enhance and update their technical expertise. If precision and reproducibility are the primary purpose of the test facility s quality concerns, then apparatus, instruments, equipment and computerised systems have to comply to the highest technical standards in terms of validation, maintenance and calibration. 

With regard to Quality Assurance inspections, it can be observed that, in principle, there are two kinds of them Either an inspection is directly concerned with the conduct of a specific study or study part, or the inspection is taking stock of the general state of the test facility in a manner not related to any study. Both of these will have to be described in detail in the respective Quality Assurance Standard Operating Procedures. 

It is counted among the responsibilities of test facility management to ensure that appropriate and technically valid Standard Operating Procedures are. .. followed , even though Study Directors and Quality Assurance personnel would certainly be in a better position to judge the observance of SOPs by study personnel. The real importance of this responsibility lies thus less in the detailed remonstrances with single persons, or admonitions of individual errors, but in the stipulation that management has to act and to implement adequate measures if Quality Assurance reports a less than optimal observance of SOPs. 

One of the most important Standard Operating Procedures which, however, isn t even mentioned in the OECD GLP Principles, is the one which describes the basic processes and procedures for the writing, approving and revising SOPs, the SOP on SOPs . In this document the general format of the test facility s SOPs should be laid down, and it should describe when and how revisions of SOPs should be done. 

In this area test facility management has again to play a central role Test facility management is responsible for ensuring that appropriate and technically valid Standard Operating Procedures are established . Management does not have to write or to issue technically valid SOPs, as for this task it may simply not have the necessary expertise. In many cases a Study Director would be the most capable person for describing all the standard procedures to be... 

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