In this article, you will learn when is necessary preventive maintenance (PM) according to the FDA requirements.
Preventive maintenance shall be done based on the following 4 reasons and triggers:
More specifically, preventive maintenance must be performed to any equipment or machinery related to the following areas:
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 email@example.com.
SUBSCRIBE AND FOLLOW US TO LEARN MORE.
For more details about when is necessary preventive maintenance, 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 when is necessary preventive maintenance (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: WHEN IS NECESSARY A PREVENTIVE MAINTENANCE
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.
For more information about when is necessary preventive maintenance, refer to: