by Michael Ambrosio | Oct 7, 2024 | GMP and Compliance
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...
by Michael Ambrosio | Oct 7, 2024 | Calibration
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,...
by Michael Ambrosio | Sep 30, 2024 | Mapping
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,...
by Michael Ambrosio | Sep 29, 2024 | GMP and Compliance
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...
by Michael Ambrosio | Sep 29, 2024 | Calibration
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...
by Michael Ambrosio | Sep 2, 2024 | GMP and Compliance
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. Calibration programs help to: Maintain Product Quality:...
