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...
This Webinar provides guidance on the elements of selection and evaluation of Single-Use systems or components. Implementation of Single-Use Systems (SUS) starts with an effective selection of Single-Use components. The focus of the presentation will...
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...
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...
ISPE Women in Pharma® Cooking with Chef Pietro in Italy THIS EVENT IS SOLD OUT. If you have any questions or would like to be put on a waitlist, please contact the office at office@ispeboston.org. Fight the winter blues by joining Women in Pharma®...
