Most pharmaceutical companies think calibration is a compliance checkbox. The ones who pass their audits know it’s a business strategy. I’ve been doing this for, well, let’s just say a long time. I’m 61 now, and I’ve learned a thing or two the hard way. And one of the...
Environmental monitoring systems are the invisible guardians of quality, monitoring temperature, humidity, and pressures to ensure safe, effective medicines.
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...
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...
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.
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