In this article, you will learn why is mandatory a preventive maintenance program according to the FDA requirements.
Government regulations require that regulated companies bring preventive maintenance to their instruments and equipment.
Some industries work under stricter preventive maintenance requirements due to the type of process and product.
Failing to comply with the preventive maintenance requirements, can cause fines, loss of business, or damage to a business’s reputation.
Moreover, the cGMP and the QSR Quality System Regulations mandate to establish a reliable preventive maintenance program.
In addition, the preventive maintenance management system serves as a logbook and tracking system of all preventive maintenance in the chronological order that was done.
It helps to bring the evidence that preventive maintenance has been done to each equipment by date during its life cycle.
REGULATORY CONSEQUENCES TO NOT PERFORM AN ADEQUATE PREVENTIVE MAINTENANCE ON-TIME?
Failure to adhere to proper preventive maintenance program and schedule is considered a violation of US Federal Regulations on good manufacturing practices.
As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to bring preventive maintenance actions, and failed to design and implement an effective preventive maintenance control program or management system either manual or electronic.
In some cases, it may result in an FDA warning observation, product hold, product recall, etc.
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at firstname.lastname@example.org.
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REFERENCES: WHY IS MANDATORY A PREVENTIVE MAINTENANCE PROGRAM
STATUTORY AND REGULATORY REQUIREMENTS –
TITLE 21–FOOD AND DRUGS
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Sec. 211.67 Equipment cleaning and maintenance.
TITLE 21–FOOD AND DRUGS
PART 820 Medical Devices
Subpart G–Production and Process Controls
Sec. 820.70(g) Production and process controls.
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