Cleaning validation : Concept, objective and method

ISBN-13: 9783659253690 / Angielski / Miękka / 2012 / 60 str.

Shirish R. Patel; K. K. Patel; Nilam K. Patel

Opis

With increasing healthcare awareness, manufactures have become more and more conscious about quality and safety of pharmaceutical products. Cleaning being considered as an vital element to prevent cross-contamination, greater emphasis has been given to validated cleaning procedures to ensure the quality of the final product as well as the compliance with stringent regulatory requirements of various countries. This book provides an overview on various aspects of cleaning like, importance of cleaning procedures, need of validation, methods of cleaning,acceptance criteria for validation, parameters for validation, methods of validation, sampling methods for validation, recovery studies, change controls, validation protocol, validation report, re-validation and special topics in cleaning validation. This information should give overview of cleaning procedure, importance of validated cleaning procedures and their effect on the overall quality of a pharmaceutical product.

O autorze

Myself, Mr. Shirishkumar Rameshbhai Patel, has done my Master of Pharmacy in the department of Quality assurance from the Ganpat University, Gujarat, India. I am having more than five years of teaching experience at undergraduate as well as post graduate level. I am Assistant Professor at Hemchandracharya North Gujarat University, Patan, India.