Sourcing Chemicals

We set the bar high because we want you to have a reliable supply of chemicals that consistently meet The PCCA Standard, above and beyond USP specifications. Because your pharmacy and patients matter to us, and because the best clinical outcomes start with the best ingredients.

To ensure that we find the best active pharmaceutical ingredient (API) manufacturer every time, we developed PCCA API Manufacturer Qualification Program.


Manufacturer Assessment

At the heart of our API Manufacturer Qualification Program is our 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.

Our proprietary assessment also considers larger qualifications such as FDA registration, FDA inspection, current good manufacturing practices (CGMPs), and inspections by other health authorities.

  • FDA registration
    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.
  • FDA inspection
    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 the location of the manufacturer (e.g., EU, Canada, Australia, Japan, UK, etc.)

Sample Testing

Even if a manufacturer passes our API Manufacturer Qualification Assessment, we also obtain a sample of the chemical we plan to buy from them and test it in our Quality Control lab like we do with every other chemical we 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
  • Brix
  • Melting point
  • Specific gravity
  • Particle size
  • Solubility
  • Viscosity
  • pH
  • Other chemical identifications


PCCA Formula Testing

We also verify the chemical with our Formulation Development department, and they conduct further testing to ensure that the chemical works in our formulas when necessary. Because we won’t create formulations for our members with products that we don’t stand behind.


Manufacturer Reassessment

Not only do we extensively assess API manufacturers and their products before we approve them as a source, we then re-assess the manufacturer every two years. We also verify their licenses initially and annually thereafter with the appropriate regulatory agencies.

Manufacturer Assessment

At the heart of our API Manufacturer Qualification Program is our 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.

Sample Testing

Even if a manufacturer passes our API Manufacturer Qualification Assessment, we also obtain a sample of the chemical we plan to buy from them and test it in our Quality Control lab like we do with every other chemical we receive.

PCCA Formula Testing

We also verify the chemical with our Formulation Development department, and they conduct further testing to ensure that the chemical works in our formulas when necessary. Because we won’t create formulations for our members with products that we don’t stand behind.

Manufacturer Reassessment

Not only do we extensively assess API manufacturers and their products before we approve them as a source, we then re-assess the manufacturer every two years. We also verify their licenses initially and annually thereafter with the appropriate regulatory agencies.