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 API . IMPORTANCE OF CLEANING VALIDATION. WHAT IS THE IMPORTANCE OF CLEANING VALIDATION? Heart of pharmaceutical activity. Related to safety & purity of 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 (ICH Q8) and Quality Risk Management (ICH Q9).

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 - and there is still much speculation about the implementation time after publication.

PHARMACEUTICAL QUALITY ASSURANCE. DEPARTMENT OF PHARMACEUTICAL SCIENCES AND TECHNOLOGY. BIRLA INSTITUTE OF TECHNOLOGY,MESRA. LEARNING OUTCOME. After watching this video we are going to LEARN:- Installation Qualification Of Dry Powder Mixers. Operational Qualification. Performance Qualification. Revalidation Criteria. …

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 containers is performed utilizing a dry heat oven.

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 following slides review the nature and extent of the contents of the VMP and what the manufacturer’s strategy should be.

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 Management. 6 Management of Processing Quality.