The quality control of pharmaceutical products is an important issue for manufacturers and testing laboratories. Assessing the analytical performance of laboratories is essential to ensure the accuracy of analytical results. The participation of the laboratories in the aptitude tests makes it possible to evaluate these performances.
Created in 1970, BIPEA is a scientific and independent non-profit organization offering proficiency testing programs and reference materials in the fields of human and animal nutrition, the environment, cosmetics, pharmacy and hygiene. BIPEA is ISO 17043 accredited (scope 1-1495 available on www.cofrac.fr), ISO 90001 certified and brings together more than 2,500 test laboratories in 120 countries.
In the pharmaceutical field, BIPEA offers 3 aptitude tests: PT 104′Microbiology of pharmaceutical process waters‘: count of total viable aerobic germs; PT 97 ‘Purified water for pharmaceutical applications‘: Endotoxins and TOC are offered for analysis on a sample of purified water; TP 98 “Residual solvents in excipients”: Ethylene oxide and dioxane on a polyethylene glycol sample are offered for analysis.
These three programs are designed according to the requirements of the pharmacopoeia (European, American, Japanese pharmacopoeia or any other pharmacopoeia).