What is the PCCA Compounding Standards Compliance Program?
The PCCA Compounding Standards Compliance Program was devised in response to demand by doctors and patients for a way of identifying compounding pharmacies that comply with the compounding regulations and professional practice standards of Australia.
These standards put into practice the professional practice and legal requirements for pharmacists dispensing compounded medicines. The program involves development and implementation of the required standard operation procedures for your specific pharmacy practice and then regular onsite inspections to ensure compliance.
The standards cover all areas of complex compounding
- Professional practice
- Personnel qualification and training
- Documentation systems
- Processes and Ingredients
- Quality assurance
- Complaints and recalls procedures
This is a rigorous process but when prescribers and patients see the PCCA Compounding Standards Compliance Program ‘Tick” of approval, it means peace of mind.
Your assurance of ingredient quality
“Lives depend on a job well done.” For PCCA, our supplier of all raw ingredients it’s not just a saying, but the way they approach quality. We have access to over 4,560 active and non-active chemicals – more than any other compounding pharmacy supplier can offer – the competitive advantage this brings our lab is the industry’s most comprehensive quality control and assurance program PCCA brings to those chemicals every day.
Here is how PCCA differ from the competition:
Every Lot – Not Just the Initial Lot – Is Tested
- PCCA do not solely rely upon the USP or manufacturer’s label to ensure the quality of the chemicals received.
- Every lot received is tested using Fourier Transform Infrared Spectroscopy, ultraviolet-visible analysis, melting point, specific gravity, solubility and chemical identifications.
- Additional testing of APIs is done using actual formulations.
14 checks and analyses are performed on each chemical lot as it comes in and is repacked
- Nine qualitative and quantitative analyses are performed on every incoming chemical lot before it is released for repacking or sale.
- Each lot is tested against the certificate of analysis (C of A), including: USP, EP, NF, FCC, ACS and PCCA standards.
- After initial testing, all results are reviewed for accuracy by a second QC analyst.
- Chemicals are tested only by degreed Chemical Analysts.
Five Validation Checks Are Made During Each Repack Order, Including:
- Written and audited Label Control procedures.
- Production audits performed by the QA department followed by a second identity test performed by QC department on repacked chemicals.
PCCA rejects about 180 chemical lots per year, or just over three lots received per work week
- PCCA is fully registered by the FDA, DEA and State of Texas as a manufacturer and follows current Good Manufacturing Practices (cGMP).
- Only FDA-registered and GMP-certified manufacturers are used for the purchase of active pharmaceutical ingredients (APIs).
- PCCA is licensed by the TGA in Australia
- PCCA is endorsed by The Pharmacy Guild of Australia
Quality Doesn’t Stop With High-Quality Chemicals
Dallas Parade Compounding Pharmacy (Compoundingpharmacy.com.au) then completes the quality circle by testing their compounded preparations through an independent lab – Eagle Analytical Services. Eagle Analytical helps pharmacists close the quality circle by testing preparations on an ongoing basis including sterility testing, bacterial endotoxins, microbial detection, beyond-use date (BUD) determination and active-ingredient potency. They not only test the preparation, they test the processes behind the preparation, giving pharmacies top-to-bottom confidence in their products.
- Dedicated service, expertise, and state-of-the-art equipment.
- Timely online access to test results.
- Find out more about Eagle Analytical’s quality testing by visiting eagleanalytical.com
Now you know what the “Tick of approval” means, accept nothing less.More Articles