Open AccessINDUSTRIAL PROCESS VALIDATION OF SOLID ORAL DASAGE FORM: A REVIEW
Author(s) -
Vishal Sharma,
Ajay Rana,
Nimrata Seth
Publication year - 2013
Publication title -
international research journal of pharmacy
Language(s) - English
Resource type - Journals
ISSN - 2230-8407
DOI - 10.7897/2230-8407.04514
Subject(s) - process validation , quality assurance , quality (philosophy) , process (computing) , computer science , product (mathematics) , risk analysis (engineering) , reliability engineering , verification and validation , engineering , operations management , mathematics , medicine , philosophy , external quality assessment , geometry , epistemology , operating system
Validation is the important step in gaining and maintaining the quality of the final product. Validation of the individual steps of the processes is called the process validation. Different dosage forms have different validation protocols. Validation is therefore is one element of quality assurance programs and is associated with a particular process therefore word validation simply means “assessment of validity” or action of proving effectiveness. Validation thus provides a higher degree of assurance that the manufacturing process consistently meets the pre-determined specifications and the quality products output can be used to increase productivity, its consistent quality and decreasing the need for processing and market complaints of the drug product. This overview examines the need for pharmaceutical validation, the various approaches and steps involved