Retrospective evaluation of the manufacture process of Oroken 200mg tablets

ABSTRACT

GMP requires that all procedures should be properly validated...To ensure that processes and procedures remain capable of achieving the intended results, they should routinely undergo critical approvals. To obtain this purpose, the retrospective validation is proceeded with data provided from at least 10 batches. According to a C. Estampe study, we carried out a retrospective validation with Oroken 200mg tablets produced at the Saint Genis-Laval factory of Rh«ne-Poulenc Rorer (French).