Quality Assurance for the Custom Compounding Pharmacy: A Checklist for Success
Excellent quality assurance is important in any field, but especially in a custom compounding pharmacy. Lack of proper quality control can have adverse effects on our patients, affecting their health and possibly damaging your reputation. Ensuring that you have quality assurance and quality control (QA/QC) measures in place at any pharmaceutical site is essential to meeting regulatory standards and protecting your patients’ safety.
Management Involvement and Commitment
The top-down approach is one in which objectives, guidelines, and plans come from top management. We more commonly hear this in the context of corporate projects, but it applies to patient-focused fields as well. When supervisors are actively involved in quality management, they set the tone for the pharmacy and offer an example for employees to follow.
This can be achieved by addressing the following:
- Defining the quality assurance policy
Lapses in quality management occur when quality standards are left undefined. Having a clear policy in place makes it easier for pharmacy workers to follow.
- Ensuring the policy is implemented and followed
Establishing a clear policy is only the first step. Management needs to make sure employees understand the measures put in place. Not only does this mean proper training to educate employees what is meant by quality, it also means helping them understand why upholding quality is important.
- Confirming that there are adequate resources
It does no one any favors to create quality assurance measures that cannot be carried out to their full potential. This leaves employees in the same uncertain position in which they started. Before putting policies into place, management should take inventory of what resources are available to them. Any quality measures should take into account manpower and the ability to sustain the effort, scaling the program to suit the pharmacy accordingly.
Documentation Is King
It isn’t enough to have established quality management measures in your pharmacy. It’s imperative to make sure they’re being followed. Otherwise you may discover inconsistent application of your guidelines. This means monitoring adherence to policies and keeping a written record.
All plans and standards that are part of your quality assurance measures should be in writing. That way, anyone can refer to them when necessary. To simplify guidelines for daily use, perhaps a flow chart can be created for the workers in your pharmacy. And it’s important to be practical: not everyone will refer to your quality assurance plan if it’s located in a thick binder. Nevertheless, a comprehensive written plan should exist for times when a procedural question arises, regulatory audit, or a need for review, in the case of updating measures to reflect reality.
Employee training logs also need to be maintained. They prove that your workers were educated in the QA/QC measures in your pharmacy.
A Checklist for Everything
Many intricate steps are involved in the daily operation of a compounding pharmacy. Much effort goes into ensuring the quality of sample preparations. With everything involved, it’s easy to understand why a step is skipped over or missed.
Those errors, however, can be easily avoided. While certainly helpful, you don’t need new or innovative technology. Something as simple as a checklist is enough.
The best thing about a checklist is that it’s customizable. You can tailor the items included to suit your needs. It can be as general or as specific as you need, a feature that is perfect for pharmaceutical compounding, which requires several minute details.
You can create checklists for a variety of uses, including:
- What to include in a compounded medication, for example a treatment for hypothyroidism.
- Regular testing of the equipment, sterility, and air quality of the area where you do your compounding.
- What appropriate protective gear pharmacy employees need to wear.
- How to review prescriptions and ingredient packages.
- What procedures to follow when giving a patient their medication.
Using checklists ensures that those in your pharmacy don’t miss any steps in processes and quality measures are up to snuff. What pharmacy doesn’t want that?
Quality assurance policies are important for pharmacies to have. Not only does it help maintain your products’ integrity, it benefits your patients. They can be secure in the knowledge that your preparations are of high quality and prepared under the most stringent conditions. This can fuel customer satisfaction and strengthen reputation, which can ultimately lead to boosts in business.
At Pharmaceutica North America, we are committed to providing you with superior quality compounding ingredients to help you meet your quality assurance standards. Contact us today to learn more about our products.