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FDA’s Take

One of the most oft cited GMP issues is not having sufficient work plans in place or not following the ones you do have.  Many of the recent high visibility Warning Letters, 483’s and consent decree list inspection issues with procedures, with many coming under the realm of GMP Maintenance.

With stepped up FDA enforcement, companies need only look to 21 CFR Part 211.67 Equipment cleaning and maintenance for the FDA’s ammunition.  Of particular note in this GMP subsection is the description of what should be included in a maintenance procedure:  “A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance

These 2 recent examples typify how the FDA write companies up in Warning Letters:

             “Failure to establish and follow written procedures for cleaning and maintenance of equipment…”

and

            “Your firm fails to have an adequate equipment cleaning and maintenance procedure or program to prevent contamination that would alter the safety, identity, strength, quality…”

While most top notch Life Science manufacturing companies have the basics in place, it is surprising to learn how many of the past years 483’s and Warning letters, especially those involving production stoppages, relate to maintenance.

Hot Topic

At the recent SMRP Pharmaceutical and Biotech SIG meeting held in Indianapolis, Indiana on July 30, 2012, work plans were also a hot topic.  The discussion touched on the perennial issues of developing and maintaining work plans, but rapidly shifted to discuss the changing FDA expectations companies were seeing.  This included:

  • Standardizing work plans for similar equipment
  • Standardizing work plans across departments and facilities
  • Setting critical criteria level and recording those values
  • Plan level of detail

CMMS’s Role

CMMS software can play a significant role in providing the tools needed to establish, use and maintain GMP compliant maintenance work plans.  One of the new functions of Blue Mountain RAM work plans are the ability to set acceptance criteria on the plan itself.  This enables the capture of important data that can justify action taken on the asset.  For example in the case of condition based monitoring, an operating temperature and its relation to tolerances could be recorded.  Collecting the data wirelessly directly into the database is an added benefit.

I see many companies adopting functionality like this and receiving the benefits of both increased compliance and productivity.  Is your company working to improve its maintenance work plans?  If so, drop me a line and let’s chat about what’s working and what’s not!