QUALITY CONTROL, A WARRANTY OF FITNESS From the laboratory to industrial scale , an unavoidable problem : Le polymorphisme
"In recent years, manufacturers have realized the essential side of the analysis, "says M. David, Commercial Director Calytherm.
The services company specializing in the field of physico-chemical analysis, based in the Hérault, is precisely repositioned last year in supporting pharmaceutical development to meet demand.
"The ICH guidelines provide decision trees to guide the industry in controlling polymorphism" says Fabienne Lacoulonche. "We use it for writing the CTD (Common Technical Document). Complexity is to anticipate changes polymorphism, both laboratory scale, pilot and industrial "completes the founder of Calytherm.
"This requires the mastery of these techniques, and the ability to interpret the results "confirms M. David (Calytherm).
Pharma Industry # 61 January / February 2012 Raphaëlle Maruchitch