How to Fill a Preventive Maintenance Form as per cGMP

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.

preventive maintenance Form
Preventive Maintenance Form – example

 

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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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Quality procedures templates

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

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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.

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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

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!