21 CFR refers to a set of regulatory standards dictating the rules and roles of the U.S. Food and Drug Administration (FDA). 21 CFR stands for Title 21 of the Code of Federal Regulations. As the name suggests, this set of rules is issued by the U.S. federal government. The Food and Drug Administration (FDA) is responsible for the enforcement of these rules.
The conditions put forth by 21 CFR have a specific bearing on the production of such goods as food, pharmaceuticals, medical devices, dietary supplements, cosmetics, and biologics. In turn, 21 CFR standards are also of vital importance to the maintenance teams responsible for ensuring the continuity, compliance, and safety of such operations.
21 CFR regulations are designed to protect public health by ensuring the safety, efficacy, and security of the goods produced by these operations. This also places the onus on maintenance personnel to understand their obligations under the terms of 21 CFR. In the discussion that follows, we’ll take a closer look at 21 CFR standards, the ways maintenance teams help organizations meet these standards, and the role that management software like a robust Computerized Maintenance Management System (CMMS) can play in helping your organization achieve and retain 21 CFR compliance.
What types of organizations need to stay 21 CFR compliant?
21 CFR compliance is of particular importance to the medical and pharmaceutical industries. Organizations involved in the research, manufacturing, distribution, and sale of products regulated by the FDA must take steps to ensure they are aligned with federal standards and guidelines on clinical trials, manufacturing practices, labeling requirements, and more.
Below, we take a closer look at some of the industries where public health, safety, and compliance depend on adherence to 21 CFR regulations:
- Pharmaceutical companies that manufacture and market prescription drugs must comply with stringent safety, efficacy, and manufacturing regulations.
- Biotechnology firms must ensure the safety and effectiveness of products such as vaccines, biologics, and gene therapies.
- Medical device manufacturers must adhere to specific guidelines for the design, testing, and quality control of items such as bandages, EKG monitors, and surgical robotics.
- Food and beverage companies must ensure that food production, packaging, storage, distribution, and labeling are compliant with standards for safe consumption.
- Cosmetics companies must ensure that their products are properly labeled and safe for public use.
21 CFR: the fundamentals
Organizations that are obligated to comply with 21 CFR regulations will typically implement programs designed to ensure adherence. Below, we identify some of the steps commonly involved in developing an effective 21 CFR compliance program.
- Quality assurance, including publication of detailed standard operating procedures (SOPs), performance of internal audits, and regularly scheduled equipment testing
- Documentation and organization of clear, accessible, and accurate records on processes such as product development, testing, manufacturing, distribution, and more
- Risk management, with regularly scheduled internal and third-party audits to ensure ongoing compliance, identify potential instances of non-compliance, and initiate resolution of these issues
- Employee training, ensuring that personnel understand their roles in maintaining compliance and that all team members are apprised of the current regulatory requirements, procedural norms, and ethical standards
- Corrective and Preventive Actions (CAPA) aimed at investigating instances of non-compliance, identifying their root causes, and taking steps to prevent the recurrence of these issues
It’s also important to note that 21 CFR regulations are updated annually, with the revised version typically becoming available on April 1 of each new year. This means the compliance program outlined above must also be revisited and revised on an ongoing basis, particularly where the content and focus of employee training are concerned.
21 CFR and maintenance teams
21 CFR standards are of particular relevance to maintenance teams. The safety, healthfulness, and regulatory compliance of pharmaceuticals, medical devices, and food products largely depend on the environments in which they are produced as well as the equipment used to produce them.
Effective asset management and facility maintenance play an important part in helping organizations align with 21 CFR standards. This also means that maintenance teams will play a central role in ensuring 21 CFR compliance.
Below, we take a look at some of the provisions of 21 CFR that are of particular importance for maintenance teams:
- Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals
- Section 211.67 requires organizations to schedule regular equipment cleaning and maintenance as well as proper documentation of these tasks.
- Part 820 — Quality System Regulation (QSR) for Medical Devices
- Section 820.72 mandates the performance of routine and scheduled equipment calibration, inspection, and maintenance.
- Part 110/117 — Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
- Section 110.40 and Section 117.40 require the performance of timely equipment maintenance as well as the prevention of contamination and consistent quality assurance in the process of food production.
Several sections of 21 CFR apply even more directly to maintenance work. Below, we take a closer look at two particular sections–Part 11 and Part 820.
Relevance of Title 21 CFR Part 11 to maintenance teams
21 CFR Part 11 provides conditions and compliance guidelines around the handling of electronic signatures and electronic records. Maintenance teams in industries such as pharmaceuticals, medical device manufacturing, and food production often use electronic systems to document maintenance processes, facilitate effective work order management, create audit trails, and more.
The guidelines provided in Part 11 are directly relevant to these activities.
Relevance of 21 CFR Part 820 for maintenance teams
21 CFR Part 820–mentioned in the section above– is sometimes also referred to as Quality System Regulation (QSR). Part 820 pertains specifically to the rules and regulations surrounding the manufacture of medical devices. QSR outlines the standards that an effective quality management system must adhere to to ensure consistent, controlled, and compliant production of medical devices.
- Section 820.70—Production and process controls—mandates the routine and regularly scheduled calibration, inspection, and maintenance of manufacturing equipment with full adherence to manufacturer guidelines along with documentation explaining any intentional deviations from these guidelines.
- Section 820.72–Inspection, Measuring, and Test Equipment—requires the proper maintenance, calibration, and validation of all tools used to inspect, measure, and test production equipment.
How can a tech-enabled maintenance department ensure compliance with Part 11 and Part 820?
Tech-enabled maintenance teams have a particular advantage in achieving compliance with the guidelines highlighted in Part 11 and Part 820. For instance, maintenance personnel using CMMS or other maintenance software solutions have access to sophisticated features for:
- Enhanced recordkeeping with automatic backups, secure storage, and centralized accessibility,
- Improved tracking of maintenance activities through features like electronic signature verification and time stamping.
- Preventive maintenance activities at pre-scheduled intervals to ensure optimal performance of equipment as well as operational continuity and ongoing compliance.
- Reduced human error through the use of work order templates, streamlined completion procedures, and accessible maintenance history.
- Audit preparedness through the compilation of historical data, ongoing performance monitoring, and accessible maintenance records.
CMMS platforms and 21 CFR compliance
A CMMS platform can be particularly valuable to organizations in FDA-regulated industries such as pharmaceuticals, medical device manufacturing, and food production. The right CMMS solution can make it easier to implement a compliance program, and more cost-effective to remain compliant with 21 CFR regulations. This, in turn, can spare your organization the costs and consequences of non-compliance.
Among the CMMS features that can be particularly helpful in keeping your organization compliant are:
- Automated maintenance scheduling
- Detailed record-keeping
- Audit trails
- Preventive asset management
- Standardization of maintenance procedures
- Enhanced quality control
- Integration capabilities
- Mobile accessibility
- Advanced performance metrics
- Continuous improvement
By leveraging a leading-edge CMMS software like Limble, organizations can improve the efficiency, effectiveness, and compliance of their maintenance operations, and consequently, ensure adherence to the conditions outlined by 21 CFR.
Indeed, the right CMMS can significantly ease the burden of meeting the otherwise rigorous demands of 21 CFR for your maintenance team, and in doing so, can improve the efficiency and productivity of your operation on the whole.
Download our 21 CFR compliance kit
Want to be sure that your organization is in full compliance with current federal regulations? Download our 21 CFR Compliance Toolkit today and prepare to ace your next audit.
