Founded in 1919, Pfanstiehl will soon celebrate its 100th year anniversary as a leader in carbohydrate and process chemistry. Since under new ownership in 2013, significant investments and improvements continue to be made. Pfanstiehl’s customers include the world’s leading biopharmaceutical and pharmaceutical companies. Our products are utilized in market-leading drugs that treat life-threatening and debilitating diseases, including cancer, rheumatoid arthritis, diabetes, etc., and have been administered to thousands of patients around the world.
Pfanstiehl has terrific track record with the FDA! As an API and Excipient manufacturer, Pfanstiehl is inspected regularly by the US FDA. We work diligently to ensure that our facility and systems are inspection ready and compliant with regulatory requirements. As an API manufacturer, FDA inspections of our facility are extensive in nature and cover many segments of our quality system; Production System, Facilities and Equipment Systems, Laboratory Controls System, Materials System, and Packaging/Labeling System. Our recent inspection covered process validation, CAPA, packaging and labeling, materials management, root cause analysis, risk assessment, software validation, 21 CFR Part 11 compliance, and laboratory controls and method development. No FDA Form 483 observations were issued and no Discussion points were made, in the recent FDA audit completed in October 2017. Pfanstiehl's quality system is based on ICH Q7. We apply the same quality system to our APIs as we do to our Excipients! Pfanstiehl is committed to regulatory compliance excellence and ensuring that our customers can be confident in the products they purchase.
We welcome our customers to come and audit our facilities, so we can show them first hand our commitment to quality and safety.
In everything we do, Pfanstiehl is motivated by a concern for both product quality and environmental/worker safety. We design and equip our plant, write our own procedures and train our people to meet or exceed US FDA, cGMP, ICH Q7, OSHA, and international regulatory and multi-compendial standards (including Chinese Pharmacopeia).