Completely revised and updated to reflect the significant advances in pharmaceutical
production and regulatory expectations, this third edition of Validation of Pharmaceutical …

Substances leached from materials used in pharmaceutical manufacturing systems,
packages, and/or medical devices can be administered to a patient as part of a clinical …

This paper summarizes parenteral drug contamination case studies presented at industry
conferences and a Food and Drug Administration advisory committee meeting in the period …

In order to understand the nuances of the European approach to validation, it is important to
understand the history of the European Regulations and the history of validation in the …

Steam sterilization is widely used across the healthcare industry and is the most
documented and standardized sterilization method. Despite its broad application, there is …

Validation specifies and coordinates all relevant activities to ensure compliance with good
laboratory practices (GLP) according to suitable international standards. This includes …

Maintenance of appropriate quality of the pharmaceutical product is considered vital for
achieving success in the global trade. Monitoring microbial distribution and identifying the …

Many new biological entities use unique processing flows and steps that can require non-
traditional thinking about process validation. Large-molecule drug products and attendant …

Microbial contamination of drugs and biologics causes immediate adverse effects on health,
including morbidity and mortality1-3, as well as long-term adverse impacts, such as cancer …

In 1900, the eighth revision of the United States Pharma-copeia (USP) was recast from its
traditional focus of how to make medicines to the role it would eventually take as a book that …