As an example, for environmental monitoring, the new standards specify, that you must do surface sampling monthly in conjunction with media fill testing. This raises several questions that you need to make sure you’ve addressed. Who’s doing what? Where is it being done? And what, exactly, needs to be done? Will training be done in-house, or will it be outsourced? Do you have a sampling plan or diagram? What needs to be monitored and sampled, using what equipment? All of these considerations and more should be addressed in your SOPs for environmental monitoring.
Similarly, while the areas and items to be cleaned have not changed much, your SOPs and documentation should include daily cleaning of any pass-through and sink. You should also check – and this is a notable change –whether you are using sterile agents in the primary engineering controls (PEC) because this is now a requirement to provide further protection for the cleanest area of your pharmacy. Another important change is that you must apply sporicidal disinfectant agents at least monthly throughout the sterile compounding areas. Consequently, you should address many of the same questions as above in your SOPs for cleaning. Who performs your daily versus monthly cleaning? Where is it being done? And what is the backup plan if your regular cleaners are absent?
Cleaning to the new standards also depends on knowing the actions and dwell times of your cleaning products. Are you already working with your vendors to source those sterile agents? Have you labeled the agents clearly and have you distinguished between sterile and non-sterile agents? Do you want to store sterile and non-sterile products separately, so you don’t accidentally use non-sterile agents in the PEC? You also need to ensure that everyone who is performing cleaning and disinfection activities has the appropriate PPE and is following the proper hand hygiene and garment procedures.
Finally, it’s important to remember that USP <797> resets the categories for CSPs, which affects the BUDs . For the Ready phase, know what categories you are compounding and where in your facility you are compounding them.
SET Phase : Tailor Your QA/QC Program According to USP 797 Revisions
In moving to the Set phase, you need to put in place some QA/QC policies and practices, even if you still have some catching up to do on training, competency, and environmental monitoring. The goal is to ensure, on an ongoing basis, that you are always preparing CSPs preparation in accordance with the requirements of USP <797>.
Any QA/QC program begins with SOPs that describe what, when, where, and how of various aspects of the program. At its most basic, the SOPs for your QA/QC program need to define a system for the prevention and detection of errors – including a way to evaluate complaints and adverse events – and outline processes for following up to ensure you are addressing any concerns. You may already be doing some of this work, but as a reference point, USP Chapter 1163 , titled Quality Assurance and Pharmaceutical Compounding, is an outstanding resource. In addition, remember that while the designated person(s) is where the buck stops for your QA/QC program, everyone in your facility has a role to play.
Your thinking about your QA/QC program might begin by identifying gaps in your most challenging areas for maintaining compliance. For those areas, define some standards, from mere competence to outstanding, and outline how you can get your facility to achieve those standards. What will the metrics be? How will reporting occur? How will key information be disseminated?
Finally, QA/QC is a continuous process, but you will need to review it at least once a year. This review should include your SOPs, the outcomes of any quality improvement projects, errors, and metrics you’ve been tracking.
GO Phase : Implement Your QA/QC Program with USP 797 Revisions
In the Go phase, you will want to think hard about how to roll out and continuously improve your QA/QC program. This means creating processes that go beyond meeting the minimum standards and, instead, aiming for best practices. What that looks like will differ from facility to facility, but what follows are some key examples.
- We’ve mentioned the need to review SOPs annually, but a best practice might be that you include front-line staff in those reviews, as they are critical eyes and ears for potential gaps in your policies. You might also audit how you communicate any policy changes.
- We’ve noted the need to complete training on a regular basis as defined by the new standards, but tracking trends in the proficiency rates of your people can shed some light on the efficacy of your training methods.
- For competency as well, there are defined times and frequency to test your people, but are you fully documenting any corrective action plans for failed competencies – and defining means of remediation?
- For environmental monitoring, you may be meeting the minimum standards but are you assessing trends in results for each site and, if there are problems, have you assessed where the problems lie? And if everything seems perfect, are you checking to see if your processes are too lax?For cleaning, you may be carefully documenting the work being done, but are you actually there, observing the cleaning process? Are you reviewing cleaning agents for efficacy?
- For BUDs , you may be properly labeling and storing your products, but have you simulated a recall and put processes in place should a recall occur?
Seize the Opportunity of Being USP 797 Compliant with Our Guidance
Compliance with USP <797> requires understanding both the new standards and the need for continuous assessment. The latter is why a comprehensive QA/QC program is so essential and an opportunity to optimize any aspects of your operations. Think of it as a system that includes procedures, activities, and oversight to ensure the quality of any CSP your facility produces and helps you guard against fatal errors.
Finally, as this article makes clear, the QA/QC program is made up of a number of individual components, but they do not and cannot work in isolation. Nor can your people. This is a team effort, the responsibility of every person in your organization. Instilling that sense of responsibility is the ultimate key to success. See more tips and help map the next phase of your journey – quality assurance and maintenance of compliance in the on-demand webinar Ready, set, GO for USP 797 compliance.
