The USP standards generally outline characteristics of a quality assurance program, but really do not specifically go into detail or requirements for a program. The pharmacist has the professional discretion to create a quality assurance program for his or her practice site. According to the USP<797>1, characteristics of a QA program include the following:
- Formalization in writing
- Consideration of all aspects of the preparation and dispensing, including environment testing and verification results
- Description of specific monitoring and evaluation activities
- Specification of how results are to be reported and evaluated
- Identification of appropriate follow-up mechanisms when action levels or thresholds are exceeded
- Delineation of the individuals responsible for each aspect of the QA program
Manufacturers are required to have a CAPA (Corrective and Preventative Action) plan and keep a book that can be easily accessed and reviewed by staff and inspectors. Some state board of pharmacy inspectors are also looking for a CAPA book in compounding pharmacies. What is a CAPA? It is a written plan to:
- Identify a discrepancy or problem in a process or facility
- Identify the corrective action taken to prevent recurrence of the problem
- Document that the corrective action has resolved the problem
A CAPA plan can easily be incorporated into a compounding pharmacy operation or facility and it is a written documentation that demonstrates to inspectors or management how problems are addressed and resolved within the pharmacy. It is a step-by-step approach to address problems that may occur in labeling, packaging, formulations or compounded processes, ordering, customer service, and equipment. Key elements need to be included in a CAPA: root cause analysis, corrective action, and preventative action. There are several good free CAPA templates that can be downloaded from the internet and customized to meet the needs of the pharmacy. Once a form is selected and customized, create a 3-ring binder book that has dividers for the areas previously listed (labeling, packaging…). Place a blank form that can be copied along with instructions or a standard operating procedure (SOP) on how to conduct the CAPA and document it on the form. The book should be kept in the pharmacy in a location that is easily accessible and available for the staff, management, and inspectors to review and use.
First, the CAPA report should include the name of the reporter, name of the person assigned to address it, and the date of the occurrence. The issue or problem should be briefly described or outlined. Second a root cause analysis should be done to identify possible reasons why the issue occurred. Next, an immediate corrective action or plan for the staff should be described or outlined in detail. This plan should also identify who is responsible for it and the date(s) that it was implemented and completed. A long term or preventative action plan also needs to be described or outlined in detail with to ensure or minimize the risk of recurrence of the problem or issue and also include who is responsible for it and the date(s) that it was implemented. Finally, there should be an evaluation of the implementation and completion of the plan, including a timeframe and measurable metrics to review the effectiveness of the plan so that possible improvements can be done.
Here is an example of how CAPA can be used in a 503A pharmacy. An ophthalmologist within a health-system complained of particulate matter in an intraocular injection prepared by the centralized compounding pharmacy. The injection had been prepared, tested for sterility and endotoxins, and quarantined until the testing was complete before being released to the OR. The pharmacist started questioning the OR staff about how the syringe was handled or prepared to go into the OR as part of the root cause analysis and it was discovered that the scrub tech actually transfers the content of the syringe into an open sterile basin and redraws the solution back into another sterile syringe. It was determined that there may be particulate matter in the open sterile basin that is mixing with the sterile solution. The pharmacist obtained 5 syringes of the same lot from the OR and sent it to an analytical lab as part of the immediate, corrective action to identify any particulate or sterility problems with the batch prepared by the pharmacy. The test results came back negative and it was confirmed that the root cause for the contamination was the transfer process by the surgical technician. To prevent this problem from happening again, the pharmacist proposed that the OR change the transfer process and use a closed transfer system, such as a sterile Luer Lock-to-Luer Lock syringe connector so that the contents of the original syringe can be transferred to the new syringe without any exposure to the external environment. The OR immediately implemented this plan and the problem was resolved. If the CAPA had not been done, the particulate contamination may not have been discovered or realized by the pharmacist. It is a win-win situation for everyone: the physicians, pharmacy staff, nursing staff, and most importantly, the patient.
Maintaining a CAPA book and using a CAPA plan is a good quality assurance measure that is easy to use and implement. All pharmacists should consider incorporating a CAPA plan as part of their QA program. It is a good tool to identify and resolve problems and it documents every aspect of the plan.