CSV FDA Warning Letters : Qualification

Date: 08 April 2010
Link: FDA Warning Letter (New Window)

Observation

7. Your firm failed to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 C.F.R. § 211.68(a)].
For example, your firm has not conducted performance qualification for the (b)(4) unit-dose packaging machine (b)(4)™ to ensure its proper performance. Your firm has also failed to provide documentation to establish that the (b)(4)™ or (b)(4)“Bingo Card” repackaging equipment (for liquid and solid oral doses, respectively) has been qualified before use.
In your response of January 18, 2010, you stated that your firm has completed “machine validation” on several pieces of repackaging equipment used in production and will complete the process by the end of February 2010. This response is inadequate in that it fails to adequately describe how and on which pieces of equipment qualification will be performed. Your response provides an intended future date of completion, but fails to address whether manufacturing operations will continue before the machine qualifications are finalized, and, if so, what additional controls will be implemented during this interim period.

Comment

This observation is a failure to provide documented evidence that a system (in this case a machine) is fit for purpose. Although the initial observation relates to Performance Qualification (PQ) the process of ensuring a system is fit for purpose (Qualification) should be ensured through the design and installation of the equipment.
The regulated company should have a Site Validation Master Plan (VMP) or Computer Systems Validation policy which clearly defines the process for the definition of requirements, design documentation and testing strategy is fundamental to ensuring compliance with the agencies (FDA, MHRA, etc) rulings and expectations.