Validation and product development. Quality assurance

      Аннотация: Now a days, There are increasing use of drugs in human population for curing their diseases.So for that,all pharmaceutical companies are developing the new and new techniques to manufacture of new drugs to come over public demand. So for new drugs, companies are also developing the new instruments for manufacturing of newer drugs. so before starting of manufacturing of any drugs, that particular instrument should be well Validated for better results.FOR EX. one instrument is using for multipurpose.so product change over will be there.so between time of product change over CLEANING VALIDATION should be done. so overall in pharmaceutical industry the validation is require for all instruments.And PROCESS VALIDATION is also carried out of Dosage forms. I also discussed in brief about Calibration, Computer, Utilities and analytical method validation.And Validation is nothing but one type of documented evidence which meet the quality specification. About my this book,i wrote this book on basis of PG(QA) level PHARMACY students. In India,most of all PG PHARMACY universities including this book syllabus. so this my book will be helpful to All Pharmacy PG level students and industry people.

Ключевые слова: Process Validation, Pharmaceutical validation, Calibration of equipment, Validation master plan, Computer validation, Cleaning validation and Analytical method validation