GMP News - Quality Assurance

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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25.08.21

FDA: Warnings about Side Effects and Contamination with Hand Disinfectants

The FDA is warning against certain hand sanitizers because of side effects and contamination, especially during the COVID-19 pandemic. The latest notifications concern alcohol-based hand sanitizers.

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25.08.21

Warning Letter regarding Insufficiencies Around Access Control

During an inspection the FDA found insufficiencies around access authorization. Read more about remediation activities required by the US FDA. 

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18.08.21

Audit Trail-Deviations in the course of Inspections

Computerised systems are also audited as part of inspections by the authorities. Klaus Feuerhelm, former GMP inspector at the Regierungspräsidium Tübingen, has compiled a TOP 3 list of the most frequent complaints for 2020 based on his inspections. TOP 1 on the list is the audit trail review. What deficiencies were found here?

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18.08.21

Medical Cannabis in Malta

Malta´s Medicines Authority issued a document which provides general guidance on medical cannabis production. According to the agency applications for medical cannabis production must be completed and the licence and EU-GMP certificate must be granted before production activities are carried out.

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