SOP for Safety In Quality Control Laboratory OBJECTIVE: The purpose of this SOP is to lay down a procedure to describe safety rules and precautions during working in the Quality Control department. SCOPE: This SOP is applicable for guidelines regarding safety hazards occurring during laboratory working and to guide on the safe handling of various …
Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals. Hazard:- Any circumstance in the production, control, and distribution of a pharmaceutical which can cause an adverse health effect. Hazard analysis:- The process of collecting and evaluating information on hazards which should be addressed in the HACCP plan. Traditionally, the Hazard Analysis and …
Hazard and risk analysis in Pharmaceutical Products Read More »
What is an Active Pharmaceutical Ingredient? “active pharmaceutical ingredient (API) Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological …
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 …
