How to Fill a Preventive Maintenance Form as per cGMP

In this article, you will learn how to fill a preventive maintenance form according to the FDA requirements.

The preventive maintenance record may include, but, is not limited to complete the following sections and information related to the preventive maintenance work performed to the equipment, (as applicable)

• Preventive Maintenance number:
• Version
• Reason and Description of Preventive Maintenance.
• Related Topics, Documents, or Procedures.
• What is included in the Preventive Maintenance?
• Why is the Preventive Maintenance provided / justification?
• How was the Preventive Maintenance performed?
• Where was the Preventive Maintenance done?
• When was the Preventive Maintenance done?
• Preventive Maintenance Duration
• Preventive Maintenance Type categorization
• Impacted areas of the machine, materials, and parts used.
• Preventive Maintenance Testing Requirements
• Preventive Maintenance Execution.
• Actual test results, functional testing, adjustments & completion
• Preventive Maintenance status, pass, or fail.
• Preventive Maintenance performed by name and signature, date
• Preventive Maintenance reviewer name and signature, date
• Closure and approval.

The following picture shows an example of the preventive maintenance form.

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.

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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 how to fill a preventive maintenance form (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.

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REFERENCES: HOW TO FILL A PREVENTIVE MAINTENANCE FORM

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 how to fill a preventive maintenance form, 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