Standard operating procedures (SOPs): reason for, types of, adequacy, approval, and deviations from and revisions to.
Standard Operating Procedures (SOPs) are required in order to comply with the Good Laboratory Practice Standards (GLPS) as promulgated in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 40 CFR Part 160. Paragraph 160.81 (a) states: "A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study." Types of SOPs include administrative and personnel, analyses, substances, quality assurance and records, test system, equipment, and field related. All SOPs must be adequate in scope to describe the function in sufficient detail such that the study data are reproducible. All SOPs must be approved by a management level as described in a corporate organization chart. Signatures for SOP responsibility, authorship, and Quality Assurance review adds strength and accountability to the SOP. In the event a procedure or method is performed differently from what is stated in the SOP, an SOP deviation is necessary. As methods and procedures are improved, SOP revisions are necessary to maintain SOP adequacy and applicability. The replaced SOP is put into a historical SOP file and all copies of the replaced SOPs are destroyed.
Isaman
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QA Consulting and Testing, Salem, Utah 84653, USA.
Thelin
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D005161:Facility Regulation and Control / Q000145:classification / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards*; D006291:Health Policy / Q000331:legislation & jurisprudence*; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards*; D011785:Quality Assurance, Health Care; D014481:United States