Good Manufacturing Practices (GMP) - An Overview
fifty five. several remarks proposed that FDA delete the need that individuals conducting the audit be ``appropriately experienced'' from the next sentence of proposed Sec. 820.22(a), since it is subjective and never in step with ISO 9001. FDA has deleted the prerequisite from Sec. 820.22(a) for the reason that Sec. 820.25 staff calls for that this