Why is Mandatory a Preventive Maintenance Program as per GMP?

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 ramon.cayuela@ciqa.net.

SUBSCRIBE AND FOLLOW US TO LEARN MORE.

For more details about why is mandatory a preventive maintenance program, follow us.

Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You Formal Training about why is mandatory a preventive maintenance program (PM).

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

Get in compliance today, CONTACT US (Hablamos Español)

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

Subpart D–Equipment

Sec. 211.67 Equipment cleaning and maintenance.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67

TITLE 21–FOOD AND DRUGS

PART 820 Medical Devices

Subpart G–Production and Process Controls

Sec. 820.70(g) Production and process controls.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

For more information about why is mandatory a preventive maintenance program, refer to:

httpss://www.fda.gov/media/73942/download

httpss://www.fda.gov/media/94076/download

httpss://www.fda.gov/media/70106/download

httpss://www.fda.gov/media/102633/download