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Essentials of an Effective SOP

BayBiotech.NET

Standard Operating Procedures (SOP) are valuable tool that go beyond the basic procedural description of materials and methods and provide details about the appropriate precautions. A well written SOP is always a binding document in a regulatory environment and defines the details of the procedure to be followed across the board within an organization to perform a specific procedure.

A well written SOP for a particular procedure should evolve with time after repeating the process under Research and Development Unit by testing the feasibility of the steps that makes it an easy to follow methods and minimizes the risks for Out of Specification reporting later on. A well evolved SOP has its origin from a simple stepwise flow chart of a complete process. If any changes are made in the process the SOP version in use must be updated by approval of the appropriate authorities and must be brought in use and supersede any other previous versions.

A typical SOP contains the following elements:

A Header which shows the Title of the SOP, Original Issue Date, Revision/Review Date, number of pages contained in the SOP, who wrote the SOP, and the Approval Signature.

• purpose and scope
• definitions
• materials and equipment needed
• safety concerns,
• who is responsible
• step-by step procedure with identification and emphasis of "critical steps"
• records to be kept
• copies of forms to be used
• References.
SOPs should be reviewed annually at a minimum.

“A well written SOP must have some room for flexibility and ensure that the procedure is compliant with the laws and regulations that you have to support for the purpose of your work.”

References: 1.SOPs: A must for sites, Appl Clin Trials, March 2010.
2. The SOP, http://www.hawaii.edu/ehso/bio/theSOP.htm

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