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.)