ISPE India Pharma 4.0 - Advances in GxP Applications of Computer Systems, Automation and Robotics. ISPE India invites you on a transformative journey at the Pharma 4.0 conference where Subject Matter Experts and industry leaders will Showcase the...
Cleaning and disinfection processes are often undervalued. This presentation reviews the regulatory requirements and ‘best practice’ recommendations for cleaning and disinfection of controlled manufacturing areas. The pertinent regulations and...
Regulatory observations are clearly demonstrating the safety concerns about unexpected peaks, or unknown components discovered in related substance analyses, which are typically performed using chromatographic techniques. However, they may also...
Part 1: EM Trending Requirements Overview on requirements and guidelines on EM data analysis Considerations for EM data analysis using computerized system versus manual systems including speed of analysis, accuracy, volume of data Routine...
Although QRM is not new (cf. CHQ9 - 2005), the regulatory focus on QRM will increase with the arrival of the European Medicines Agency’s Annex 1, which was reviewed by the US Food and Drug Administration, the World Health Organization, and the...
While regulations regarding GMP for APIs clearly define compliance needs, the responsibility for defining necessary GMPs and controls for excipients in a specific medicinal product rests with the Manufacturing Authorization Holders (MAH)...
Maintaining and improving GMP compliance of cleanroom manufacturing operations is a mandatory requirement for all pharmaceutical manufacturers. In addition, cost and sustainability of manufacturing operations are an increasing focus, especially given...
The presence of endotoxin in sterile pharmaceutical products presents a significant risk to patients. The primary source of endotoxin is pharmaceutical grade water, due to the potential for Gram-negative bacteria to be present. The water source of...
Sanitization and Biofilm Microbial growth in water generation, storage and distribution systems should be controlled as much as possible and reasonable for the application. Effective microbial-control strategies typically include multiple approaches...
Cleaning validation in non-sterile pharmaceutical manufacturing is moving towards a risk-based approach. This is a significant change in all aspects for the industry. In this presentation we will summarise the global regulatory guidelines leading to...
