BET PHARM maintains strict quality control. All injectables undergo rigorous sterility testing. We adhere to external quality control monitoring by independent labs, such as Analytical Research Laboratories for stability, pyrogens, purity and verification of prescribed potency as well as our adherence to standards set forth in the USP 797 guidelines. Our quality assurance program is designed to ensure every prescription meets your specifications. Our pharmacists have extensive training in compounding procedures and utilize a class 100/ ISO 5 cleanroom to prepare our compounds in our state-licensed facility. When you choose BET Pharmacy you can be confident your patients will receive medications of the highest quality.
Inspected and Verified
We have been awarded PCAB Accreditation in both Sterile and Non-Sterile Compounding ensuring the quality and consistency of our medications.
BET Pharm follows the standards of practice outlined in the United States Pharmacopeia (USP) chapters 71, 85, 795, 797 and 800. Compounding sterile injectable pharmaceuticals demands a high level of quality with careful, precise, and competent staff consistently performing all of the required tasks correctly every single time.
BET Pharm’s Standard Operating Procedures guide our compounding process and detail the systematic approach to the daily functions of the pharmacy and it’s personnel. Maintaining quality by performing multiple checks in a number of compounding procedural domains ensures our system to be as fail-safe as possible. We continuously monitor, modify, and improve our processes through routine education and training.
Standards Compliance
When BET compounds a medication you can be sure it’s being made following the guidelines in USP Chapters 71, 85, 795, 797 and 800. BET also follows the direction of each board of pharmacy jurisdiction in which we are licensed. We must follow and maintain the strictest of any one state’s rules in order to ensure that we are in compliance.
QA/QC
BET Pharm uses the highest quality ingredients in our compounds by purchasing USP or NF grade material only from FDA inspected facilities. Every active pharmaceutical ingredient we purchase comes with a Certificate of Analysis (COA) which assures it was manufactured under current good manufacturing practices (cGMP) and conforms to the standards set by the United States Pharmacopeia or National Formulary.
Analytical Testing
Each of our compounds are analyzed by a third party laboratory prior to being released. This ensures the safety of our clients by certifying the sterility and efficacy of our medications. Analytical testing results of our compounded sterile preparations are available upon request.
Engineering Controls
Our Secondary Engineering Controls (SEC) include a NEW state of the art clean room with 4 areas allowing us to compound both non-hazardous and hazardous sterile and non-sterile preparations utilizing positive and negative pressure environments. Within each of these areas we have Primary Engineering Controls (PEC) that achieve or exceed ISO 5 standards giving us the ability to maintain a sterile environment while we compound.
Environmental Monitoring
Our Standard Operating Procedures outline our daily and monthly cleaning procedures. Daily, all work surfaces, floors, and PEC’s inside each clean room suite are cleaned and disinfected. We perform a complete top to bottom cleaning and disinfection of our clean rooms inclusive of work surfaces, storage surfaces, PEC’s, walls, and ceilings each month.
In order to validate our cleaning procedures BET Pharm routinely monitors our clean room environment; exceeding the guidelines set out by USP 797. On a weekly basis our staff takes environmental samples of areas inside the clean room and are sent out for analysis by a third party lab for microbial testing. By doing so, we’re able to continually monitor for any possible contamination and take immediate action if needed as well as adjust our cleaning procedures to effectively solve the issue.
We also contract with a third party certifier to perform air quality sampling and re-certification of our Engineering Controls every six months to validate their performance.
Personnel Validation
BET Pharm assesses staff for proper aseptic technique, correct garbing and gowning procedure, media fill testing, and gloved fingertip sampling prior to entering the clean room to compound. Each compounder is validated for their sterile practices while compounding and supervised by the pharmacist in charge. Our staff continually trains on compounding procedures and is required to be observed and tested semi-annually to be certain their quality practices are maintained.
Equipment Validation
BET Pharm inspects and routinely validates the equipment we use for our compounding procedures. Our Primary and Secondary Engineering Controls, the equipment we use to sterilize our glassware and compounding utensils, and especially the sterilizing grade filters used to safeguard against contamination are all validated to ensure that our compounds are processed accurately and correctly every time.
How BET Pharm Assures Quality
If you are assessing compounding pharmacies these are the Quality Controls that should be in place to ensure you’re receiving the highest quality compounds.
- We are in compliance with guidelines for sterile and non-sterile compounding, USP <797> & <795>
- BET Pharm is held to the standards of every board of pharmacy we hold a license in and we are routinely inspected by the Kentucky Board of Pharmacy for <795> & <797> compliance
- BET performs sterility analysis on each batch of sterile compounds by a third party laboratory
- We utilize sterilizing grade filters (0.2 micron) in our ISO Class 5 laminar airflow hood or Biological Safety Cabinet inside an ISO Class 7 clean room
- For our Altrenogest 500mg formulation we terminally sterilize our diluent via autoclave and our active via gamma-irradiation
- We perform post-filtration filter integrity testing using the bubble point method to ensure the filter maintained function through the sterilization process
- We conduct weekly and monthly environmental monitoring and perform laboratory analysis of air and surface samples in our clean room and other controlled environments
- All of BET’s Compounded Sterile Preparations (CSPs) are made by a licensed pharmacist
- BET Pharm staff is trained and evaluated in aseptic techniques, gowning procedures and proper use of engineering controls to ensure sterility
- We routinely have an independent third party inspect and certify our Primary and Secondary Engineering Controls
- We utilize ONLY pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers
- Available upon request, we retain all Certificates of Analysis (COAs) on our Active Pharmaceutical Ingredients (APIs)
- BET’s master formula database and batch records for each compounded preparation is maintained and retained giving us the ability to track individual prescriptions back to the original record
- Our pharmacists verify the potency of finished compounds through quality control checks including weight, volume and yield
- Our compounding process includes the use of bar-coding and balance-computer integration to ensure we have properly weighed the correct ingredients
Our friendly pharmacists are always happy to help. Give us a call or create an account today!