The PCCA Standard™
PCCA goes above and beyond the required standards by using only the best active pharmaceutical ingredients (API) through stringent testing with their own PCCA API Manufacturer Qualification Program.
PCCA has an extensive API Manufacturer Qualification Assessment which considers over 40 important factors within the manufacturer’s quality management system, manufacturing and materials management systems, and distribution system. The assessment covers everything from facilities and equipment to processes, personnel and paperwork.
Their proprietary assessment also considers larger qualifications such as FDA registration, FDA inspection, current good manufacturing practices (CGMPs), and inspections by other health authorities.
The FDA regulates domestic manufacturers as well as foreign manufacturers who sell products in the U.S. All of them have to register with the FDA, and they have to register their products as well.
The FDA inspects all of the manufacturers of FDA-approved drug products (i.e., finished drug products), but it does not inspect all API manufacturers. This is why it is important to us that the manufacturers we qualify have been inspected by the FDA or their local regulatory agencies.
Current Good Manufacturing Practices (CGMPs) Compliance
Various regulatory agencies around the world establish and enforce CGMPs, which are requirements that ensure manufacturers use the proper methods, facilities and controls to consistently make active pharmaceutical ingredients and drug products according to high standards.
Inspection by Other Health Authorities Based On Location of the Manufacturer (e.g., EU, Canada, Australia, Japan, UK, etc.)
Even if a manufacturer passes their API Manufacturer Qualification Assessment, they also obtain a sample of the chemical they plan to buy from them and test it in their Quality Control lab like they do with every other chemical they receive.
The lab analyst performs an identity test using Fourier transform infrared spectroscopy (FTIR) and compares the results with the latest USP compendial standards. Then they assess the chemical with any of the following methods and criteria that are applicable:
- Refractive index
- Melting point
- Specific gravity
- Particle size
- Other chemical identifications
PCCA also verifies the chemical with their Formulation Development department, and conduct further testing to ensure that the chemical works in their formulas when necessary. Because they don’t create formulations for PCCA members with products that they don’t stand behind.
Not only do they extensively assess API manufacturers and their products before they approve them as a source, they then re-assess the manufacturer every two years. They also verify their licenses initially and annually thereafter with the appropriate regulatory agencies.
Quality Assurance & Quality Control
PCCA is an FDA-registered and -inspected chemical repackager and relabeler. They meticulously evaluate every lot of chemical they receive — this means there are over 20 checks, tests and verifications.
PCCA knows that everything from the chemicals, to the base to the formula, to the support, all add up to the final compounded preparation that can change a life, or even save it. That’s why The PCCA Standard doesn’t just apply to our chemicals and bases; it applies to the formulas we develop and the science behind them, all to help PCCA members confidently and carefully compound prescriptions for their patients.
Exclusive Bases & Formulas
The Science Behind PCCA Quality & Reliability
Visit http://pccarx.com/science to view Journal Articles, Abstracts, Posters, Technical reports, Case Studies and Sponsorships to view the significant resources that PCCA has collected in their research of products for compounding.