GMP News

Warning letter due to lacking cleaning validation, stability testing and content determination

When various active substances are being manufactured in a shared system, there are specific requirements for cleaning validation. Read here how severely defects regarding cleaning validation, stability testing and content determination can affect an FDA inspection at an API facility.

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Warning letter to Indian drug manufacturer due to various deficiencies

Because of the GMP deficiencies found during an inspection and the company's response, which was deemed unsatisfactory by the FDA, the agency has now issued a warning letter. The main complaints: incoming goods testing, release, equipment design and the HVAC system.

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Data integrity still in the focus of FDA: new warning letter to Japanese API manufacturer

The topics data and data integrity are still in the focus in FDA inspections. Find out more about the details of a warning letter to Japanese API manufacturer Yuki Gosei Kogyo Co. Ltd.

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EMA publishes list of contact details for pharmacovigilance enquiries

The EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.

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FDA´s Action Plan for Biosimilars

The US Food and Drig Administration (FDA) has published its Biosimilars Action Plan in July 2018.

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