FDA 483 Tips #1

Routine inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Related FDA483/Warning Letter

Subsection  D. (A&B) No written procedure is approved by QA describing Preventative  Maintenance tasks and their frequency for concerning monthly tasks for the walk-in [redacted] RH stability chamber. reads in part: ***Responsibility ***The Facilities Group (C) is responsible for maintaining and repairing the Chamber ***The Facilities Group will coordinate all (D) repair work and perform calibrations per the schedule ***”.  Review of the last printout for monthly tasks completed were identified in as “confirmed”.  According  to ????? he gets a work order with the tasks to complete and after he confirms the work order is complete he (E & F) throws the work order away.  Hence, there is no way in to identify what tasks were actually performed.
http://www.fda.gov

IF IT’S NOT DOCUMENTED IT’S NOT DONE

  1. PM tasks should be defined in an SOP. If using a vendor to do the work include a generalized protocol as an attachment to the document.
  2. PM’s should use a proactive process that monitors the “Health” of the unit, not just a process that only looks at physical issues such as door seals, chamber lights, etc.
  3. Maintenance should be discussed and classified as Scheduled (PM) and Non Scheduled (breakdown).
  4. Defining the requirements is the responsibility of both Chamber Ops and Facilities. Controlled by Stability/Quality
  5. Work needs to be completed in a cGMP process
  6. Original documentation should be recorded and filed for all work in a filing program that is quickly accessible and references only the specific unit. The SOP should include a form for the documentation of work.

Poll Question

  • Who knows if their Maintenance/Facilities personnel are cGMP trained on an annual basis?

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