GMP News - Quality Assurance

16.09.21

Signal Management: EMA and EC agree to further extend the Pilot

The EMA and the European Commission have agreed to further extend the pilot on signal detection in EudraVigilance by marketing authorization holders until the end of 2022. MAHs with APIs included in the EMA list of active substances and combinations involved in the pilot should continue to monitor them in EudraVigilance.

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16.09.21

EMA supports use of global Track & Trace Systems

The EMA supports recommendations for the use of global track & trace systems to mitigate the risk of drug shortages and fight against falsified medicines. To date, track & trace systems have been designed and implemented with a local or regional focus, without taking into account whether they can exchange information with other systems.

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15.09.21

Industry still facing Problems with Root Cause Investigations

Deviations and CAPA are still important issues during inspections. Inspectors' summaries of their observations show that things do not always work as they should. This also applies to root cause investigations.

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15.09.21

Record Number of Fake Drugs seized during INTERPOL Operation

During an action week coordinated by INTERPOL against illegal internet trade checks led to the discovery of very large numbers of fake and illicit drugs. Overall the operation resulted in the seizure of around 9 million medical devices and illicit pharmaceuticals.

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15.09.21

USP with new Chapter on Supplier Qualification and Guidance for associated Risk Assessments

Even though the USP has no direct force of law, certainly not in Europe, interesting points for use in risk-based supplier qualification programmes can be found in a newly proposed USP chapter.

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15.09.21

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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09.09.21

FDA gets expanded Power to prevent Medical Device Supply Disruptions

Due to the Corona pandemic, there were supply shortages of medical device products in the USA. To get these shortages under control in the future, the FDA gets expanded power. What is planned?

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09.09.21

Final EMA Guideline: Quality Requirements for Combination Products

Following a draft version, the EMA has now published the final guideline, which describes what documentation is required on the subject of quality for combination products in order to gain and/or maintain a marketing authorization. The guideline consists of 22 pages with 10 chapters.

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08.09.21

ICH publishes Guideline Q13 on Continuous Production

End of July 2022, the ICH (International Council for Harmonisation) published the draft guideline on continuous manufacturing, which had been awaited for two years. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues.

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08.09.21

EMA adopts final Public Statement on Pyrrolizidine Alkaloids

The HMPC adopted the final Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs. Amongst others, it is stated that PA specifications are no longer considered necessary for essential oils.

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02.09.21

GDP Non-Compliance Report for German Wholesale Distributor: RP is not Continuously Contactable

The competent authority of Germany has entered a new GPD Non-Compliance Report dated 21 July 2021 into the EudraGMDP database due to critical violations of GDP requirements. One of the reasons is that the Responsible Person (RP) does not fulfil the responsibilities personally and is not continuously contactable.

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01.09.21

FDA Warning Letter due to contaminated Hand Disinfectants

As a result of problems with contamination of hand disinfectants - like with Burkholderia cepacia, a manufacturer in the USA receives a Warning Letter from the FDA.

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01.09.21

Batch Documentation: who needs to review?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to review the batch documentation?

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26.08.21

Clinical Trials: Application of the CTR confirmed as of 31 January 2022

It is official now: the EU Commission has confirmed the full functionality of the Clinical Trials Information System in the Official Journal of the EU. This means that the Clinical Trials Regulation 536/2014 (CTR) will become applicable on 31 January 2022. What are the GMP / GCP changes associated with this?

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26.08.21

What is Similarity?

The EMA published the final reflection paper on "Similarity". The paper shows how statistics should be used in drug development when a comparative assessment of quality attributes (QAs) needs to be made for pre- and post-manufacturing changes, biosimilar development as well as generics´ development.

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