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THE PHARMA REVIEW (JANUARY FEBRUARY 2015)

Including and Emphasizing Precautions in SOPs and STPs An Often Missed/Neglected Opportunity to Communicate About Risks to Shop Floor and Laboratory Staff in the Pharmaceutical Industry

Dr Saranjit Singh

Introduction: ICH has extended Quality-by-Design (QbD) concept to manufacturing of pharmaceuticals through its guidelines Q8-Q11. The concept is based on the principle that quality cannot be tested into a product; it has to be built-in by design. It is a very right development as pharmaceuticals are used to improve health or save lives of the critical patients. Finished pharmaceuticals are manufactured in millions of units, so a single serious failure can adversely impact large number of patients. 

 

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