cGMP: What It Is and Its Importance in the Pharmaceutical Industry
Introduction Current Good Manufacturing Practices (cGMP) represent the guidelines enforced by regulatory agencies such as the U.S. Food and Drug Administration (FDA) to ensure that pharmaceutical products are consistently produced and controlled according to quality...
A Comprehensive Guide to the Calibration of Humidity Instruments
Humidity is a crucial environmental parameter in many industrial, commercial, and residential applications. Accurate humidity measurements are vital for various processes, such as pharmaceuticals, food production, agriculture, and HVAC systems. However, over time, humidity sensors can drift and produce inaccurate readings due to wear, exposure to contaminants, or harsh environmental conditions. Therefore, regular calibration of humidity instruments is essential to ensure their accuracy and reliability.
Mapping Stability Chambers – Why It’s Important and the Methodology
In the pharmaceutical, biotech, and medical device industries, ensuring the stability of products is a critical aspect of quality control. Stability chambers are essential tools used for testing how products react under different environmental conditions over time,...
ISO 9001:2015 Certification for a Calibration Contractor
Introduction ISO 9001:2015 is one of the most recognized international standards for quality management systems (QMS). It sets out the criteria for a QMS and is based on several quality management principles, including a strong customer focus, process-based...
Why It’s Important to Calibrate Pharmaceutical Instruments
Introduction Calibration is a critical process in the pharmaceutical industry, ensuring that instruments used in drug production and testing perform accurately and reliably. The role of calibration extends beyond merely maintaining the functionality of equipment—it...
Why Have A Calibration Program?
Pharmaceutical manufacturers must have a calibration program for their equipment to ensure the accuracy and precision of measurements that directly impact the quality, safety, and efficacy of their products.