Critical Role of Calibration in the Weight Loss Pharmaceutical Industry
According to the Centers for Disease Control and Prevention, more American’s are nearing the definition of obesity.
With this growing weight trend, it is no surprise that the weight-loss market in the U.S. is worth some $72 billion. And the pharmaceutical industry is one of the most prominent players.
As with all pharmaceutical products, diet pills are heavily regulated and continuously monitored by government agencies like the U.S. Food and Drug Administration (FDA).
Given the level of scrutiny the industry is under; calibration becomes a critical aspect of quality control.
Calibration for Pharmaceutical Devices
Pharmaceutical laboratories utilize a myriad of measurement equipment, including pressure and temperature sensors, and other level measurement equipment.
These devices play a significant role in the Current Good Manufacturing Practices (cGMP), and quality assurance programs of pharmaceutical labs, and therefore their accuracy is imperative, which is why they require periodic testing and calibration.
Thermometers are perhaps the most calibrated instruments used in drug manufacturing labs. Accurate temperature readings are critical to all pharmaceutical quality assurance programs because even a slight variation in temperature during the manufacturing process can compromise the quality of the final product.
Additionally, temperature instruments such as IR thermometers, thermal imaging cameras, thermocouple probes, thermistors are highly sensitive devices that can easily become damaged during use.
Therefore, this type of equipment requires periodic testing to ensure reliability and accuracy. Moreover, proper documentation of test results is necessary to ensure traceability and maintain compliance under ISO standards.
Why Calibration is Critical in the Weight Loss Pharmaceutical Industry
The pharmaceutical laboratories are an essential component of our healthcare system, and as we mentioned earlier, they are strictly regulated to ensure public safety.
The manufacturing of weight loss medications undergoes the same level of scrutiny as other prescription drugs. Therefore, manufacturers are obligated to comply with all FDA requirements, including those of calibration services.
The FDA has established calibration requirements for pharmaceutical equipment. The set regulation establishes the following:
- Manufacturers are obligated to ensure all inspection, measuring, and test equipment are suitable for their intended purposes and capable of producing valid results.
- Equipment calibration should be part of an ongoing quality assurance routine, and if there are any errors found, manufacturers’ need to take suitable corrective action and any adverse effects must be evaluated and adequately documented.
- Provisions for maintaining, handling, preserving, and storing equipment must be documented and accessible to the technicians performing the calibration. Moreover, the procedures need to include detailed directions on how the necessary method for conducting the calibration and the acceptable limits for accuracy and precision of each instrument.
- All guidelines used to inspect, measure, and test instruments must be traceable to national or international standards.
What to Look for in a Calibration Service Provider
Calibration service providers offer a variety of services designed to help pharmaceutical laboratories and manufacturing plants attain and maintain FDA approval.
As such, choosing the right provider is critical for pharmaceutical companies. At Allometrics, we’ve been offering quality certification and calibration services for a wide range of instruments used in pharmaceutical laboratories and manufacturing plants for more than 40 years.
Our ISO 17025 accredited laboratory is capable of testing and calibrating a variety of instruments, including industrial and commercial pressure gauges, high-precision test gauges, thermocouple probes, thermostats, pipettes, and cleanrooms.
All our calibrations are NIST traceable, and our technicians are both NSF and CETA certified.
Contact us today to schedule your next calibration service.
Allometrics is the ideal calibration service provider, with more than 40 years of calibration experience, a wide range of capabilities and a state-of-the-art controlled environment lab at our disposal, we can help you achieve your calibration goals.
For more information on our services and capabilities please email us at email@example.com.