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Compliant Maintenace helps protect against "validation slip"





Compliant Maintenance ProgrammingProcedures, Practices, & Paperwork - the formula for compliance

The Second Law of Thermodynamics tells us that equipment wears out.  All things go from order to disorder.  The facility or equipment, including packaging and filling equipment, that was validated last month is in a different condition this month.  In order to maintain the validated state, regular compensation for this "wearing out" must be applied via Preventive Maintenance.  Thus 21CFR 211.67 contains some unusually specific requirements for routine maintenance.  Preventive Maintenance must be performed according to pre-approved ProceduresPractices must conform to those procedures and Paperwork must be maintained accurately to provide a history for the equipment being serviced.  These three requirements, Procedures, Practices, and Paperwork make up the Three-legged Compliance Stool common to all compliance activities.  In engineering, maintenance, and calibration (and most other) programs, without one of these legs, or a shortened leg, the stool becomes unstable.

Requirements for a compliant maintenance program also include:

Corrective Maintenance performed that does not change the validated state an uses only approved replacement parts. 

All maintenance must be performed by qualified personnel, either in-house or contracted, who are trained to perform the assigned activities. 

Maintenance activities must be reviewed (particularly to ensure no unapproved changes to equipment are made) and recorded to provide evidence of proper maintenance.

Additional requirements for a Compliant Maintenance Program are outlined in our white paper:  cGMP Maintenance Compliance - Program Considerations

All of these elements must be incorporated into a robust Maintenance Program to ensure compliance.  PTS can help your organization develop a comprehensive program using our extensive experience to guide the effort in techniques that work and avoiding concepts that are not rigorous enough or lack the pragmatism to be sustainable.

The Principal of PTS has been helping start-up and established companies as well as those under "regulatory distress" for years, working with corporate and site personnel to develop standards and administrative procedures for maintenance, calibration, and internal engineering activities.  Numerous sites have implemented our calibration and/or maintenance and engineering programs, some working under a Consent Decree or having received a Warning Letter.  Some clients have been proactive in setting up the programs as preparation for regulatory review of new facilities or just out of a desire to establish compliant programs.

Does the Quality Unit have a role in GMP Maintenance?  You bet!!  See the short Quality Approval presentation:


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Pharmaceutical Technical Services 2015