Good Manufacturing Practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. When sourcing Active Pharmaceutical Ingredients (APIs) internationally, selecting a GMP-certified supplier is non-negotiable. Here is a definitive guide on what to evaluate.
The Importance of WHO-GMP and EU-GMP
While local GMP certifications are a start, international buyers should look for WHO-GMP (World Health Organization) or EU-GMP certifications. These accreditations indicate that the facility undergoes rigorous inspections covering facility hygiene, equipment calibration, personnel training, and meticulous record-keeping.
Impurity Profiling
An API is only as good as its purity. Request an impurity profile from your potential supplier. You need to know the levels of organic impurities, inorganic impurities, and residual solvents. The supplier should utilize advanced analytical techniques such as HPLC (High-Performance Liquid Chromatography) and GC (Gas Chromatography) to validate their CoA.
Batch-to-Batch Consistency
Request data from multiple recent batches. A high-quality API supplier will demonstrate tight consistency across batches, meaning your formulation process won't require constant adjustment. At Corex API Export, we pride ourselves on providing highly consistent bulk raw materials.
Audit Welcoming
A transparent supplier will welcome third-party audits. Whether you choose to send your own QA team to India or hire an independent local auditor, the supplier should facilitate the process openly.