Implementing “cGMP-Like” Concepts in your 503A Pharmacy Practice
Exceeding USP Chapter <797> Compliance
Many hospital pharmacies as well as independent pharmacy practices that have a compounding lab, are almost certainly classified as a 503A facility. This type of facility practice is permitted to do small-batch compounding, primarily for patient specific prescriptions, and is governed by the respective state board of pharmacy the facility is located in as well as USP General Chapters <797>, <795>, and <800>. These practices are not required to meet the additional meticulous FDA regulations of current Good Manufacturing Practice (cGMP) which are required by 503B outsourcing compounding facilities that produce large batch compounds to a wide patient population. So, why would incorporating “cGMP-like” standards and concepts be relevant in your 503A facility?
There can be a few considerable advantages gained; most importantly, aiming for higher standards, improves patient safety. Secondly, incorporating some aspects of cGMP standards allows your facility/practice to come closer towards what the FDA is looking for during inspections. General observations on most 483 Warning Letters issued by the FDA towards 503A practices go beyond <797> requirements. Knowing and implementing aspects of what the FDA would like to see can help you build a more robust program and give you more control of your space.
cGMP Concepts to Consider in your 503A Practice
Increasing the frequency of your surface and viable air sampling.
Under 503A Standards, only two sampling points are required per year (every six months). Increasing your air and surface sampling to quarterly or even monthly provides further data points for your facility to trend the results and mitigate problems should they arise.
An approach to achieving more frequent sampling is through in-house testing. This approach can also save on the additional costs and potential delays of using your contracted 3rd party certifier. In-house testing can allow your facility to respond faster should result shows levels that require action and burden your practice with reduced BUD’s.
Updating Facility Design
Under USP General Chapter <797>, Section 4 provides the minimal requirements for facilities and engineering controls (i.e. temperature, relative humidity, air changes per hour, etc.). Designing your pharmacy cleanroom to exceed the baseline requirements will help prevent breaching those minimal thresholds into non-compliance when the pharmacy experiences any abnormalities (i.e. increased staff workflow in the cleanroom).
ProPharma Cleanrooms recommends designing the pharmacy cleanroom to meet the following “working environment” standards exceeding that of USP Standards.
Temperature: 62-64 Degrees Fahrenheit - USP requires 68 Degrees
Relative Humidity: 45-55% - USP requires 60%
35-40 Air Changes per Hour for ISO class 7 rooms - USP requires 30 ACPH
Ducting Air Supply/Returns
While USP allows for both ducting air supply/returns to FFU’s or the use of a plenum above the ceiling, the FDA tends to favor ducting in cGMP practices. The facility can accurately track and validate each FFU to its respective ducting should issues occur. For negative pressure environments, ducting is critical for the safety of the facility since it exhausts air to the outside environment.
Unidirectional Workflow
The FDA likes to see the movement of product and personnel in 503B/cGMP cleanroom environments go in a unidirectional workflow. Not all 503A facilities have the ability to expand the cleanroom footprint to incorporate additional prep rooms or de-gowning stations, however, the use of pass-through cabinets and proper placement of equipment and furnishings can keep a steady directional flow of product and people to prevent cross over.
About ProPharma Cleanrooms
ProPharma Cleanrooms is a turn-key pharmacy cleanroom design/ build company servicing health system pharmacies, 503b outsourcing facilities, and 503a independent compounding pharmacies throughout the U.S. Our role is designing and building pharmacy cleanroom environments that will meet and exceed state and federal regulations and will enhance the daily workflow demands by pharmacy personnel to optimize patient outcomes.
Our experience with and understanding of the regulatory environment over decades of pharmacy practice allows ProPharma Cleanrooms to understand the history, the current process, and future possibilities of the evolving USP and FDA guidelines. Our principles are actively involved with professional organizations in both the USP and cGMP world. Our ability to call on subject matter experts if needed for any issue allows us to ensure a facility that will stand the test of time.