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Andrew Harrison is chief regulatory affairs officer and general counsel with Regulatory Compliance Associates.
Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.
Q.I work for a contract manufacturer and am in charge of the standard operating procedures (SOPs). During customer and regulatory audits, we keep being cited for inadequate SOPs. Can you give me some advice on what constitutes a well-written SOP?
A. You are not alone. In 2014, “inadequate SOPs” was one of the top five most-frequently-cited FDA 483 observations. SOPs are one of the first items auditors review during inspections. SOPs need to reflect your operations and should not be written for regulators. SOPs should be written for your personnel to conduct operations with consistency and quality thus assuring regulatory compliance. Do not write SOPs because you think the regulations require them or for a process, procedure, or operation listed in the regulations that you do not perform. This will continue to lead to audit observations.
So what are the characteristics of a good SOP? Effective SOPs are tailored to an organization’s design and needs and contain sufficient detail to allow personnel to conduct operations as management wants. If you have an experienced work force, you may need less detail. SOPs take into account who has the authority to make decisions and clearly define accountability (i.e., who per forms what actions). SOPs also provide guidance on what to do when things don’t go right; they delineate decision points and actions to take for each decision. SOPs define the outputs from each process (documentation, product), who owns the process, and identify other stakeholders for the process, which helps determine who requires training on the SOP. The SOPs also specify who needs to ensure the process is working and who initiates changes when needed.
So what do you need to consider to write a clear, concise SOP with the right amount of information accurately reflecting your established processes? Keep your mind open to different various communication types. SOPs may use various presentation styles as a means of communicating the details of the SOP.
The following are examples of presentation styles that you may want to consider using when writing your SOPs:
Determine the type of style and level of detail that is most effective for your personnel. Also, consider the predominant primary language (it may not be English) and general understanding level of your organization when writing SOPs. Depending on the make-up of the workforce, you may need to consider having dual-language SOPs, which might require translation expertise.
Certain recommended elements should be included in SOPs. Remember, the format and content of SOPs are not defined by the regulations. Each company must establish the SOP format and content that accurately reflects their operations. The seven basic elements for any SOP are:
If you keep these points in mind when writing your SOPs, you should stop receiving the ‘inadequate SOPs’ citation.
Vol. 39, No. 12
Citation: When referring to this article, please cite it as S. Schniepp and A. Harrison, “Crafting Standard Operating Procedures,” Pharmaceutical Technology39 (12) 2015.