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Preventive Maintenance in Pharmaceutical Industry

The preventive maintenance program is a focal point of GMP inspection. Industries have realized that the preventive maintenance program is a crucial component of any modern quality system because it ensures efficient GMP operations.

The purpose of this topic is to describe the procedures involved in commissioning, conducting and managing a site's preventive maintenance (PM) activities. This includes work that is related to environment health & safety regulatory requirements. This is applies to all employees responsible for any type of preventive maintenance for instrumentation, equipment and utilities. 

THE PREVENTIVE MAINTENANCE PROGRAM SHOULD DEFINE THE METHOD, FREQUENCY, EQUIPMENT SPECIFIC CHECKLIST AND DOCUMENTATION.


Pharmaceutical equipment is the material basis of drug production. It is an key element influencing business efficiency and drug quality. A single "Breakdown Maintenance" mode cannot meet the drug quality requirements. The revised version of " Good Manufacturing Practice"(GMP) has clearly proposed that equipment preventive maintenance plan and procedures must be formulated.

Large number of equipment in pharmaceutical enterprises, especially API production enterprises with insufficient personnel and low professional competence have lead preventive maintenance to become a mere formality in many enterprises.

What is preventive maintenance of equipment?
  • Maintenance performed on a regular basis to reduce the likelihood of failure is preventive maintenance. Also sometimes called planned maintenance, preventive maintenance is conducted throughout an asset's normal operating conditions.

What are the types of preventive maintenance?
Preventive Maintenance is done before a failure occurs and consists of maintenance types like: 


Time Based Maintenance
Time based maintenance (TBM) is maintenance performed on equipment based on a calendar schedule. This means that time is the maintenance trigger for this type of maintenance. TBM maintenance is planned maintenance, as it must be scheduled in advance.

Failure Finding Maintenance
Failure finding maintenance is a set of tasks designed to detect or predict failures in the protective systems or devices to reduce the likelihood of a failure in the protective system and the regular equipment from occurring at the same time.

Risk Based Maintenance
Risk-based maintenance (RBM) prioritizes maintenance resources toward assets that carry the most risk if they were to fail. It is a methodology for determining the most economical use of maintenance resources. This is done so that the maintenance effort across a facility is optimized to minimize any risk of a failure.

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Condition Based Maintenance 
Condition based maintenance (CBM) is a maintenance strategy that monitors the actual condition of an asset to decide what maintenance needs to be done. CBM dictates that maintenance should only be performed when certain indicators show signs of decreasing performance or upcoming failure.

Predictive Maintenance
Predictive maintenance techniques are designed to help determine the condition of in-service equipment in order to estimate when maintenance should be performed. This approach promises cost savings over routine or time-based preventive maintenance, because tasks are performed only when warranted.

Preventive Maintenance Program
  • Based on the qualification studies, a program for preventive maintenance of all major manufacturing equipments and critical support systems should be developed and implemented to maintain production systems in proper working condition and reduce equipment malfunctions.
  • It is to ensure that the equipments & systems continues to work under controlled conditions and maintained in the “validated state of control”.
  • The following shall be considered when developing a preventive maintenance schedule:
  1. Company history and experience with the component in critical applications.
  2. Costs for performing the maintenance or calibration.
  3. The documentation required for these activities.
  • Preventive Maintenance shall be routed through separate SOP. The records of preventive maintenance shall be maintained. Preventive Maintenance Program considers the followings:
  • Well established preventive maintenance procedures are defined for all equipments in related SOPs.
  • Preventive maintenance program is scheduled weekly, fortnightly, monthly, quarterly, half yearly or yearly as applicable to all equipments.
  • Engineering department will be responsible for scheduling tracking and excusing of preventive maintenance program.
  • Preventive Maintenance Documentation includes:
  1. Preventive maintenance schedule
  2. Preventive maintenance Checklist
  3. Preventive maintenance Record
  4. Equipment History cord
  5. Preventive maintenance SOPs

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1 Comments

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