HPLC Troubleshooting Steps for Pharma
HPLC Troubleshooting Steps for Pharma.
Pharmaceutical Quality System
European Guidance On:
HOW TO CARRY OUT A RISK ASSESSMENT
At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation relating to risk assessment in your country). However, there are two principles which should always be borne in mind when approaching a risk assessment: to structure the assessment to ensure that all relevant hazards and …
European Guidance On:
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What is Clinical Trail?
What is a Clinical Trial? Clinical trials are research programs involving people who volunteer to test a new ‘treatment’. Clinical trials aim to find out whether medical, surgical or behavioral interventions work, and if they are safe and effective in management or prevention of disease.The word intervention is a common term used for new or …
Pharmaceutical Quality System Elements & Change Management System (ICHQ10)
Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part under regional GMP regulations. However, the Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: • Process performance and product quality monitoring …
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