Ensuring Quality & Compliance: regulations and industry standards for calibration in food & pharmaceuticals.

Food and Pharmaceutical manufacturing standards are stricter than those in any other industry, affecting every aspect of research, sampling, production, and distribution. The effect of food and pharmaceutical quality on human or animal health makes these products among the most heavily regulated in today’s market.

According to U.S. Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practice (CGMP) guidelines, periodic tests and maintenance activities are crucial for the manufacturing, packaging, or handling of products that have a direct impact on public health and safety, such as food, drugs, cosmetics, medical devices, etc.

CGMP guidelines require frequent instrument calibration to ensure accurate, traceable, and repeatable measurements. This is complementary to validation and qualification activities and is an essential part of quality assurance. Consistent calibration minimizes errors and enhances measurement reliability.

As for FDA Guidelines for Calibration:

1. Calibration must be performed routinely, as per written directions.
2. Document the calibration of every device that needs calibration.
3. Specify the acceptable limits for accuracy and precision.
4. Make provisions for evaluating adverse effects caused by malfunctioning equipment and procedures for remedial action.
5. Use calibration standards that are traceable to the National Institute of Standards and Technology (NIST), other acceptable standards, or in-house standards if necessary.

How Calibration Helps the Food & Drug Industries?

Regular calibration is essential for quality monitoring and assurance. It helps to achieve regulatory compliance, build consumer trust, and improve brand reputation. It also ensures equipment performance at optimum levels, reducing breakdowns and extending its lifespan, which further improves efficiency, uptime, and cost savings. Moreover, calibration helps avoid potential recalls, litigation, and safety hazards, saving heavy costs.

What are the FDA Requirements for Calibration?

Calibration requirements for equipment are defined by Title 21 of the FDA’s Code of Federal Regulations:

• Manufacturers must ensure their equipment is suitable for intended purposes and meets national/international standards
• Calibration must be performed routinely and any errors found should be corrected and documented
• Maintenance, preservation, and storage activities need to be recorded and documented
• Procedures must be easily accessible to personnel and include specific directions on how calibration is to be performed and acceptable limits for accuracy and precision.

Importance and Role of Calibration Services!

Calibration services are essential to ensure that laboratories meet the FDA's approval requirements for production. However, it's not always feasible to perform calibration in-house. This is where calibration services come to the rescue by providing a range of solutions to help laboratories attain and maintain FDA approval for production.

When equipment or standards are sent out of the laboratory for calibration, it's crucial to qualify them to prevent incorrect readings due to different environmental conditions. Calibration services can help with this by preventing damage and eliminating the need for qualification, especially for delicate, fragile, or bulky equipment. Don't let incorrect readings or damaged equipment lead to production delays or compliance issues. Trust calibration services to provide you with effective solutions that will keep your laboratory running smoothly.