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GAMP®5 2nd Edition released!

At the end of July 2022, the GAMP organization has published the 2nd Edition of GAMP® 5. What are the main changes and developments compared to the previous version, which has been available since 2008?

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FDA expands Remote Regulatory Assessments

The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.

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FDA Warning Letter: Missing Qualification of Contract Labs for Release

In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.

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New FDA Draft Guidance "Cybersecurity in Medical Devices"

On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..." to replace the previous guidance from 2014. Why did the FDA publish this draft?

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New WHO Guidance on Data Integrity

Last year, the WHO replaced the previous Guidance on good data and record management practices with a new Guideline on data integrity. What has changed?

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FDA Audit Policy for Medical Devices: a Comprehensive Document

In the field of medical devices, the Medical Device Single Audit Program (MDSA) is accepted and even mandatory in some countries. Now, the FDA has published a very comprehensive policy on this audit approach consisting of 215 pages. 

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IT Infrastructure in GMP Inspections

The validation of computer-based systems is a regular part in GMP inspections. In this context, the IT infrastructure has also become an important topic. Read more about the regulatory requirements and deficiencies in inspection practice.

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Change Control for Computerised Systems

Change control is mandatory to maintain the validated state also for computerised systems and is subject to inspections. What are the regulatory requirements and what is the inspection practice?

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FDA Warning Letter on Significant Data Integrity Issues at Chinese Manufacturer

Data integrity issues continue to be a focus of FDA inspections. Significant problems with data proving the safety, efficacy and quality of manufactured medicinal products were among the reasons for the Warning Letter to the Chinese company BBC Group Limited.

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System Descriptions in GMP Inspections

As part of inspections the authorities also check computerised systems. Klaus Feuerhelm, former inspector at the Regierungspräsidium Tübingen, has created a TOP 3 list of the most frequent complaints for 2020. TOP 2 of the list - system descriptions. What were the deficiencies found here?

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