Guidelines for Writing an SOP

SOPs are often poorly written because little thought is given or effort made to get them right. At times they are mandated as a quick fix for a perceived problem. An organized and thoughtful approach will yield SOPs that are truly usable by the workers. 

SOPs should be written in a concise, step-by-step, and easy-to-read format. The information presented should be unambiguous and not overly complicated. The active voice and present verb tense should be used. The term you should not be used, but implied. The document should not be wordy, redundant, or overly lengthy. Keep it simple and short. Information should be conveyed clearly and explicitly to remove any doubt as to what is required. Also, use a flowchart to illustrate the process being described. Here are some guidelines for writing an SOP  

Decide what SOPs must be written based upon a review of organizational functions. 

Check to see if there is an existing SOP that can be revised or updated. 

Gather information on the procedure from reference sources and knowledgeable employees. When possible, contaa other agencies performing similar functions to see if they have an SOP, and reqnest a copy to use as a guide or source of ideas. 

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Guidelines for Writing an SOP for Mass Spectrometry, prepared by the Measurements and Standards Committee of the American Society for Mass Spectrometry, Sept. 1, 1997 (available from www.asms.org/mssop.h). 

Following such a guideline, an educated and trained person must be able to perform the described activity, therefore some detailedness is needed. It is best to let write an SOP by the person who is actually doing the respective analysis and then to ask another person for a critical review. Afterwards the SOP is released and is mandatory. It can be revised at any time then only the new version is valid but the old one must be kept in the archive. 

Apart from compliance with SOPs for biostatistics and report writing, the statistical analysis plan, the trial protocol, regulatory requirements and guidelines (ICH E3, 1995 ICH E9, 1998 ISO 9000 2005, 2005), QA auditors check the internal consistency of the trial report and appendices and between data in tables, figures and graphs and numbers cited in the text. All numbers and percentages must be substantiated by attached tables and listings. In summary, the trial report should be an accurate representation of the clinical data. Allocation of trial... 

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