News

GDP: Are Inspectors looking for Data Integrity?

Data Integrity is still a hot topic in GMP inspections. And in the GDP area data integrity is also increasingly becoming a subject, as some examples from the MHRA show.

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Falsified Medicines Directive - securPharm status report for 2018

There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018. Read more about the "securPharm Status report 2018".

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ICMRA recommendations on track & trace implementation

In October 2017, the ICMRA adopted recommendations on the implementation of Track and Trace (T&T) Systems to emphasise the importance of the complexity of these systems. This is relevant for regulatory authorities as well as for the pharmaceutical industry. Find out more about the ICMRA T&T recommendations.

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Handling and shipping of IMPs

The European Medicines Agency (EMA) published a draft guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs. Read more about the proposed guideline which lays down the principles for the two-step release and shipping of IMPs.

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Final GDP Guidance on Interpretation and Implementation published

The final GDP Guidance on Interpretation and Implementation has been published as a joint publication of the ECA Foundation and the Pharmaceutical Quality Group of the Chartered Quality Institute.

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Version 9 of the EU Q&As on Safety Features published

Safety features, which will be mandatory in the future to put the Falsified Medicines Directive into practice, must be implemented by 9 February, 2019. The European Commission has published version 9 of their questions and answers on safety features in February 2018. Find more information on the EU's revised Q&A document on safety features.

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USA: when is a product suspicious, when is it illegitimate?

A new FDA guideline is supposed to help the industry in identifying suspicious or illegitimate products. All trade partners are asked to initiate specific actions if such products turn up. Find out more about the FDA instructions in suspicious and illegitimate products.

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New EU Template for GMP Non-Compliance Statement

The GMP/GDP IWG at EMA is currently discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, and how to make risk based decisions to avoid drug shortages.

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Number of reported Counterfeits on the Rise

During the last year, the notifications on mechanical defects and reported suspicions of counterfeits increased. Distributors should also be interested in these figures.

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What is the current Status of GDP Implementation?

The European GDP Association evaluated the current implementation status of the EU-GDP guidelines in a survey. The response was interesting.

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