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Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of BioPharm International's Editorial Advisory Board.
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Q: I recently transferred to the document control department and am working with people on creating and/or revising standard operating procedures (SOPs). My colleagues have very different ideas on how much information should be included in the SOPs. Some want very detailed instructions and others want minimal information. Can you please advise on how detailed SOPs should be to fulfill regulatory expectations?
A: There is no right or wrong answer regarding how much or how little information should be contained in an SOP. Whether you work in the medical device, pharmaceutical, or bio-technology industry, you are relying on SOPs to help you perform the day-to-day activities associated with your job. The purpose of an SOP is to define the steps, in logical order, needed to perform a repeatable task and achieve a repeatable outcome. SOPs document the steps of key processes to help ensure a consistent, quality output. SOPs are useful tools for operationalizing, optimizing, and communicating important corporate policies, government regulations, and best practices for ensuring consistent, reliable, and safe medications or medical devices to patients.
SOPs should be written to allow your personnel to conduct operations in a consistent manner that will assure regulatory compliance and product quality. They need to reflect a company’s specific manufacturing or other operations. The more repeatable and consistent an operation or procedure becomes, the less waste there will be in the process. Consistency in work performance will lead to fewer deviations and investigations associated with the process, which translates into less down time and fewer product rejections. This is just good business sense.
SOPs should not be written for regulators, but should reflect a company’s operations. Writing SOPs to appease regulators or because you think the regulatory authorities require them will only lead to confusion and regulatory citations. Writing an SOP for a process, procedure, or operation that you do not perform just because it is listed in the regulations is not advised. This concept is particularly important when taking into consideration today’s environment. They are many virtual and small companies that outsource much of their operations. US 21 Code of Federal Regulations (CFR) 200.10 discusses the relationship between a contract provider and a contract giver by stating, “The Food and Drug Administration is aware that many manufacturers of pharmaceutical products utilize extramural independent contract facilities, such as testing laboratories, contract packers or labelers, and custom grinders, and regards extramural facilities as an extension of the manufacturer’s own facility.” Companies that outsource all or some of their operations should rely on their quality agreements and the SOPs of their contract providers to define how they perform the services being outsourced. Contract providers should not write an SOP that defines something they are not doing that they have contracted for another entity to do.
Some companies, in particular start-up companies, might be tempted to purchase pre-written
SOPs. This activity might be acceptable on the condition that the -purchased SOP is reviewed and the appropriate changes be made to reflect the actual operations of the company who purchased the SOP. Failure to tailor purchased SOPs to the actual specific process will most likely result in a regulatory citation for failure to follow written procedures.
Another consideration for an SOP is the format for communicating the information. A company needs to keep an open mind to various SOP formats and communication types. All SOPs, regardless of format, should offer clear step-by-step instructions and may utilize various presentation styles as a means of communicating the details of the SOP. The following examples are presentation styles to be considered when writing SOPs:
The final consideration for effective SOPs is training. The traditional read/understood acknowledgement may not be enough to assure that an employee understands the content of the SOP. Companies should consider group trainings and comprehension evaluations for determining the effectiveness of the SOP. Keep in mind, however, that just because an employee does not pass an SOP comprehension test does not necessarily mean the employee doesn’t understand. It could be an indication of a poorly written SOP or ineffective train-ing. Companies should also consider training on SOPs through the use of video recording. This could include presenting video demonstrating proper technique as well as using video recordings as on the job training tools to evaluate proper technique of an individual. The use of video recording could be most helpful for people who need to gown appropriately to enter into an aseptic manufacturing area.
Remember there is no set rule dictating the format of the SOP instructions, and it is up to the company to determine what works best for your facility. SOPs should be written to reflect a company’s business practices, allowing them to optimize efficiency and productivity of their operations. It is important to tailor your procedures to the personnel performing your operations whether highly experienced or relatively new to the regulated environment. The training on an SOP is equally as important as the information contained in the SOP, and companies need to consider the most effective way to train personnel on an SOP. The training presented may not be the same for all SOPs. Bottom line, SOPs and the associated training should be easily understood and able to be followed by the employees who rely on them to perform their job responsibilities.
Volume 30, Number 12
When referring to this article, please cite it as S. Schniepp, “What’s in Your SOP?," BioPharm International 30 (12) 2017.