Documentation is the thorn in the side of life sciences companies. The saying “if it isn’t documented, it didn’t happen” sums up the approach of the U.S. Food and Drug Administration (FDA) during inspections. A look at the data collected by the FDA makes it clear that in life sciences, standard operating procedures (SOPs) tend to be a problem. For fiscal year 2020, the most common inspectional observations for biologics, devices, and drugs involved SOPs. (1)
For biologics, companies failed to “establish, maintain, and follow manufacturing SOPs.” For devices, a “lack of or inadequate procedures,” specifically as they relate to corrective action/preventive action (CAPA). And with drugs, “procedures not in writing, fully followed,” specifically as they relate to the quality control unit. To avoid a Form 483, life sciences companies need a methodical approach to their SOPs.
Writing SOPs can be difficult when they’re just internal documents, and even more so when they’re GxP SOPs. A common problem is that SOPs aren’t standardized across the organization. A good starting place is an SOP template that ensures uniformity. The template contains required sections and optional ones (e.g., definitions), which aids the employee setting out to write the SOP.
Another consideration is regulations. When an organization has all the SOPs required for compliance, they also guarantee the quality and safety of their products. You may also need SOPs specifically for your organization that wouldn’t be mentioned in the regulations.
The employees who will use the SOPs are ideally the ones who should write them. This is the best way to ensure the SOP is an accurate reflection of what happens in practice. The SOPs don’t exist solely for compliance purposes. How much detail is included in the SOP should hit the sweet spot between too regimented and too vague. Employees that will use the SOP, but weren’t involved in writing it, can help in this regard. If they can follow the SOP and achieve the desired outcome, the SOP is effective.
To enforce new or updated SOPs, employees must have access to the new SOP and be thoroughly trained. If access is limited or inconvenient, employees will complete a process the way they’ve always done it rather than follow the procedure. Training is essential to ensure there are no misunderstandings about the new SOP. Explaining the reasoning behind each step can improve compliance to the SOP.
Once an SOP is in place and employees have had sufficient time to train on it, internal audits can determine if the SOP is being adhered to. An internal audit also reveals if the SOP is doing what it was designed to do. Even if employees follow the SOP to the letter, it might not quite achieve its objective. In that case the SOP needs to be revisited and revised. Even if the SOP does what it was expected to do, there will come a time when changes need to be made.
It seems that just as everyone’s getting used to a new procedure, it changes. And herein lies one of the biggest pain points with SOPs — updating them.
The first step is to locate the most recent version. After combing through binders and looking on individuals’ computers, it can be hard to know if you in fact are working off the most recent version. That’s why document control software is so useful when it comes to SOP compliance.
Document control software has revision control to ensure you’re updating the most recent version and that that version is the only one being used by employees. This is crucial to being compliant with the “maintain and follow” aspect of the regulations.
Software keeps you on the right version, but it also removes other headaches associated with using paper, such as rounding up old versions of SOPs. By using document control software that integrates with training software, you can ensure every employee that needs to be is trained on new SOPs and notified of this the moment a revision is approved.
Good documentation is vital during an inspection, and SOPs are only one example. It’s obvious from past Form 483 data that problems with SOPs are a continual issue for life sciences companies. Writing, enforcing, and revising SOPs according to regulations help companies pass inspections, but also continually improve and make higher quality products. While it is possible to do all this on paper, it’s easier to track, implement changes, and produce documentation for an inspector by using document control software.
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