It is an documented evidence which provide high degree of assurance that an approved cleaning procedure will provide equipment that is suitable for processing of pharmaceutical products …

ICH Q10 describes comprehensive model for an effective pharmaceutical quality system i.e., based on ISO Quality Concepts, Applicable GMP texts and also Pharmaceutical development …

Ensuring the House of Quality Is Built for Contamination Control. Risk Management. Knowledge Management. So far, the revised Annex 1 of the EU GMP Guidance has not been published - …

PHARMACEUTICAL QUALITY ASSURANCE. DEPARTMENT OF PHARMACEUTICAL SCIENCES AND TECHNOLOGY. BIRLA INSTITUTE OF TECHNOLOGY,MESRA. …

Dry heat is the most commonly used methods to sterilize and/or depyrogenate pharmaceutical components (glasswares) and products. Most often, it is used for depyrogenation of parenteral …

A Validation Master Plan (VMP) is a document that summarizes the manufacturer’s overall philosophy, intentions and approach to be used for establishing performance adequacy. The …

1 Introduction to Total Quality Management. 2 Leadership for TQM. 3 Information Analysis and Information Technology. 4 Strategic Quality Planning. 5 Human Resource Development and …