Archives for QMS
Management Review in Pharmaceutical Industry
As you know, pharmaceutical industry is a regulated industry and makes products that directly affect the health of the patient. Because all these pharmaceutical products are administered by the patient, then…
Risk Management Approach
What should be the Risk Management Approach, We all recognize that risk management could be a very good tool to avoid any major failure or disaster with in the future if we actually…
Trend Analysis a tools for Risk-Based thinking
The biggest concern in this Regulatory Challenging Environment is to apply risk-based thinking for implementing, deploying and maintaining a quality management system with limited resource There is a significant concern…
Common Mistakes during Investigation of failure
Definitely you have encountered anytime with failure and you have done the investigation. If you see the FDA 483 and MHRA observation then you will find most of the observations…