Regulation-related Trends/Others

Regulation of Nitrosamine Impurities in Pharmaceutical Products

Regulation of Nitrosamine Impurities in Pharmaceutical Products

The regulation of Nitrosamine impurities in pharmaceutical products is frequently debated in Europe and the United States. In 2018, certain nitrosamin

Subjectivity and Formality in Quality Risk Management

The revision of the ICH Q9 Guidelines on QRM reached Stage 4 of the ICH process in January 2023 and entered the implementation phase. The basic policy

FDA's Criticized Overseas Inspection Program

FDA's Criticized Overseas Inspection Program

The U.S. House of Representatives Committee on Energy and Commerce oversees the FDA's foreign drug inspection program. Members of the Committee h

FDA's Criticized Overseas Inspection Program

FDA's Criticized Overseas Inspection Program

The U.S. House of Representatives Committee on Energy and Commerce oversees the FDA's foreign drug inspection program. Members of the Committee h

FDA's Criticized Overseas Inspection Program

FDA's Criticized Overseas Inspection Program

The U.S. House of Representatives Committee on Energy and Commerce oversees the FDA's foreign drug inspection program. Members of the Committee h

Some Considerations about Process Validation

Some Considerations about Process Validation

When the FDA first introduced the concept of process validation in 1987, it defined process validation as "Establishing documented evidence which