GMP News

Northern Ireland: EU continues to look for Solutions - with interesting Forms of Documents

Are you familiar with a "non-paper"? This is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol.

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Deficient Cleaning and Transfer of a Non-Validated Manufacturing Process Lead to a Warning Letter

During an inspection of an Indian pharmaceutical manufacturer by the FDA, several serious deficiencies were discovered. For example, the cleaning of multipurpose equipment was criticised, and the transfer of a non-validated manufacturing process led to further complaints. Read more here.

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FDA Inspection Compliance Program for Combination Products

Combination products are products that are subject to different sets of regulations. Such products may, for example, consist of a drug and a medical device, or a biological component may be added. Because of the different product components, special monitoring procedures are required.

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Remote Audits from the Perspective of Notified Bodies

We have already reported on the experiences of notified bodies regarding remote audits in the past. Recently, the results of a survey addressed to Notified Bodies on remote audits have been published.

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EMA publishes updated Question and Answer Document on Combination Products

With the EU regulations 2017/745 and 2017/746 on medical devices (MDR) and in vitro diagnostics (IVDR) coming into force on May 21, 2021, new requirements have been/will be imposed on combination products with regard to their medical device component. There is an updated question and answer document (Q&A) from the European Medicines Agency on current issues.

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