Föreläsare tema renrum
Serena Steidl
Advisory Specialist
Particle Measuring Systems
Serena has a strong scientific background in Microbiology and Biotechnology. She worked in several pharmaceutical companies to support quality control departments. She is especially skilled in quality assurance procedures and has excellent knowledge of cGMP guidelines. She started her career as a quality technician, and over the years, she moved into management positions, working in immuno-chemical, chemical, and microbiological departments. She played a key role in many projects, such as disinfectants strategy, environmental sampling plan definition, lean scheduling and release of products, product stability management, method and process validation, and change control. In PMS, she splits her time between Sterility Assurance and Risk Assessments for Environmental Monitoring.
Read more about Serena’s presentation below
EU GMP Annex 1, 2022: A Focus on Continuous Environmental Monitoring
The new Annex 1, issued on 25 August 2022 in the EU Legislation (Eudralex), updates the regulation’s quality expectations regarding sterile manufacturing.
The new Annex 1 revision resulted from a long and detailed review involving many companies in the discussion that started in 2008.
The talk about environmental monitoring in the pharmaceutical industry is always detailed and contentious, the topics of classification and qualification are treated as separate subjects from routine sampling. Raw data from routine monitoring is the evidence needed to demonstrate data quality consistency and compliance with initial and/or periodic evaluation (requalification) over time. On the other hand, the most critical data concerning sterile products (terminally sterilized and aseptic products) is microbiological sampling data. In the past, pharmaceutical companies have usually carried out “random sampling” monitoring from the beginning to the end of filling, but now this is not acceptable anymore. Based on new Annex 1 requirements, health authorities want viable continuous monitoring during all the filling phases in Grade A areas.
This presentation will demonstrate some strategies that can be used to align with this requirement.