This just-released report, published by Maas & Peither AG and distributed by FDAnews, provides you with the essential in-depth knowledge you need to correctly monitor the hygienic status of your sterile drug sites and evaluate your cleaning and disinfecting measures.
Step by step, you'll go through the 4 key monitoring processes … risk analysis and defining contamination limits … planning and conducting sampling … evaluating your findings … and making modifications.
And you'll get a detailed look at monitoring and testing 3 critical areas: surfaces, personnel and air. The report also covers monitoring and testing utilities, cleansing agents and disinfectants.
Specifically, you'll learn how to set alert and action limits and the measures to take if those limits are exceeded. And you'll get in-depth coverage of:
- Sampling plans
- U.S. and EU requirements for contamination limits and monitoring frequency
- Pharma monitoring of HVAC systems
- Data management
- Physical and microbiological monitoring of clean rooms
- Operation and maintenance of HVAC systems
- Microbial contamination risks and how to investigate and manage them
It's all here in the most thorough report available: everything you need to know to successfully monitor, investigate and mitigate contamination risks at drug manufacturing plants and stay in compliance with FDA and EU regulations.
Meet the Authors
Dr. Christian Gausepohl is the head of quality assurance at Rottendorf Pharma GmbH in Germany, where he previously served as head of product transfer and process validation in pharmaceutical technology and head of dosage forming. Gausepohl is a pharmacist and teaches courses in hygiene, quality management systems, supplier qualification, CAPA, auditing and inspections, change control, PQR, documentation, technology transfer and process validation.
Paolomi Mukherji is the regulatory and compliance manager at Clarkston Consulting in the U.S. where she works with FDA- and European Medicines Agency-regulated pharma, biotech and device companies in business process improvement, product development, quality systems and change management. She previously worked as a manager at KMI/Parexel Consulting in equipment qualification, process validation and computer systems validation.
Rainer Röcker is the head of sales of the Southern Sales branch at Testo industrial services in Germany. Previously, he served as head of sales and marketing for pharmaceutical services at ServoTech GmbH, and worked in electrical design and as head of validation for the blister packaging division at Uhlmann Pac-Systeme.
Dr. Hans H. Schicht is a Swiss consultant with more than 20 years of experience in industrial HVAC and clean room design and contracting, contamination control and quality risk management. He is a former president and executive manager of the Swiss Society for Contamination Control, and has served as chairman of the International Confederation of Contamination Control Societies. Environmental
Dr. Hanfried Seyfarth served for nearly 40 years at Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss in Germany in positions including head of microbiology, head of quality control and head of process assurance.
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