| Title: Preventive Maintenance (PM) | |||||
| Guidance Number: 85 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Preventive Maintenance (PM)
Introduction
This document provides guidance in for Preventive Maintenance (PM) of direct impact systems and associated critical components used in production, storage, and testing that may affect the safety, identity, strength, quality, or purity of active pharmaceutical ingredients (API), drug products, drug product raw materials (RM), API starting materials, critical in-process materials, critical intermediates, biologics, or medical devices.
Definitions
Like-for-Like Changes – replacement of a part with a part that meets the original specification in terms of:
- Functionality,
- Input Range,
- Output Range,
- Accuracy Specifications,
- Operational Specifications, and
- Material of Construction.
- Non-Intrusive Condition Based Monitoring – inspection which does not require the equipment to be taken out of service, physically removed from the system or taken apart to access condition (e.g. visual or audible).
- Predictive Maintenance Activity – an activity in which equipment inspections or monitoring is conducted using devices that access equipment condition during normal operation (e.g., vibration analysis, oil analysis, thermography).
1. The PM Program should include or reference the following:
- List of all systems and associated components that require PM;
- Definition of responsibilities for PM requirements and activities, including on – Site contractors and vendors;
- Management of off-Site contractors and vendors performing PM activities (e.g., Quality Agreements, vendor audits, and vendor assessments);
- Method for establishing and managing PM frequency;
- Method for establishing and documenting acceptance criteria;
- Establishment and management of inspection-based PM;
- Definition and acquisition of materials and parts to be used [e.g., lubricants (food grade versus non-food grade)];
- PM activities, requirements, and checklists;
- Evaluation and documentation for addressing deviations;
- Sources of technical data and drawings [e.g., floor plans, Piping and Instrument Drawing/Diagrams];
- Change control for PM (e.g., definition of Like-for-Like);
- Removal from and return to service for PM activities;
- Management of overdue PM; and
- Documentation requirements for individual PM instructions (i.e., PM Work Orders).
2. Documented Instructions for PM Requirements and Activities (e.g., PM Job Plan) should include, as applicable, the following:
- Identification of systems and associated components;
- Instructions for performing PM, including:
– Disassembly and reassembly;
– Measurement taking;
– Adjustments and/or replacements; and
– Functional testing; - Identification of specialized tools and/or standards to be used;
- Types of inspections for wear, damage, or failure;
- Identification of documentation required; and
- Special consideration (e.g., safety precautions, permits, environment).
3. Criteria to Consider When Classifying a PM Task(s) include, but are not limited to:
- Potential for the PM Task to:
– Result in contamination of the product or materials;
– Affect the safety, identity, strength, quality, or purity of the product or materials;
– Affect the control, performance, or verification of functions that have a direct impact on product quality; and
– Affect the production, monitoring, evaluation, storage, or reporting of data used to accept or reject product or materials, or data used to support Regulatory Compliance – Practices; or
- The PM Task is a Non-Intrusive Condition Based Monitoring or Predictive Maintenance Activity.
4. PM Frequency and Rationale for the Frequency shall be based on consideration of, at least the following:
- Manufacturers’ recommendations;
- Intended use and criticality;
- Frequency of use;
- Environmental conditions;
- Location;
- Performance history including failure rates of similar systems or components;
- Potential consequence of failing to complete PM;
- Identified failure modes [e.g., Failure Mode Effects Analysis (FMEA)];
- Overall lifecycle; and
- Condition Based Monitoring (e.g., vibration analysis, oil analysis, thermography).
If required, PM frequencies may be adjusted based on the criteria listed above. The justification for establishing and/or changing the PM frequency should be provided and reviewed by Engineering/Maintenance or the Business Unit responsible for PM, and approved by the System Owner and the Site Quality Team.
PM frequency may be scheduled using either calendar time (e.g., annual) or equipment usage [e.g., every one hundred (100) hours of use or every ten (10) batches produced].
5. The System Owner should be notified when PM activities are complete and should verify that the work is complete and the system and associated components are ready for use. The System Owner should document the verification and accept the system and associated components back into service.
6. The System Owner and the Site Quality Authority should be notified if PM is not performed within the scheduled frequency.
If Critical PM Tasks or PM work are not completed according to the PM frequency requirements and the system and associated components are subsequently used, a deviation report should be written and approved by the System Owner and the Site Quality Team. The deviation report should be included or referenced in the batch record(s) for any batches or lots produced using the system and associated components.
7. Replacement of Parts should be performed as a like-for-like change. If part replacement is not a Like-for-Like Change, the change should go through the Site change control process and be approved prior to implementation.
8. PM Requirements and Activities Instructions or PM Tasks that support both critical and non-critical components should be subject to the documentation requirements for critical components.
9. PM Work should be documented. The documentation should include:
- Maintenance performed, including reference to the PM Task performed or written instructions used;
- Identification and location of the system and associated components on which maintenance was performed;
- Identification of any parts replaced during maintenance;
- Identification of materials used (e.g., food grade versus non-food grade lubricants, coolants);
- Identification of any change control requests implemented;
- Measurements or observations made;
- PM completion date;
- Signature and date of the person performing maintenance; and
- Signature and date of Business Unit owner (e.g., Engineering/Maintenance) approving the completed activities.