Contamination
Environmental Monitoring in Pharmaceutical Industry
Environmental monitoring in the pharmaceutical industry is a crucial process that involves the regular assessment and control of various environmental factors within a pharmaceutical manufacturing facility. This monitoring is essential to ensure the safety, quality, and efficacy of pharmaceutical products. The pharmaceutical industry operates under strict regulations and guidelines to ... Read More
Major Sources of Contamination in the Sterile Area
Contamination in the sterile area is a critical concern in a variety of industries. Understanding the sources of contamination is crucial in implementing effective measures to prevent and control it. The primary sources include human factors, air pollutants, equipment and materials, water and liquids, and cross-contamination. Human error is a ... Read More
Contamination Control Strategy (CCS) for Pharmaceutical Industry
Defining a well-documented cross-contamination strategy involves several key steps. When defining a CCS (contamination control strategy), it is recommended to consider not only cross-contamination but also all other types of contaminants. While the majority of available guidance (e.g ECS, PDA, Annex-1 of EU GMP) primarily focuses on parenteral preparation, it ... Read More