GMP News

New EU Commission Brexit Notice on Medicinal Products

The EU Commission published a new notice in the Official Journal of the EU on 25 January 2021. Although Brexit was a long time coming, there are supply problems for some medicinal products. The Covid-19 pandemic has therefore also prompted the EU to act. Cyprus, Ireland, Malta and Northern Ireland in particular have not yet fully adapted their supply chains.

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Track & Trace: Do Medicinal Products have to be Decommissioned when Distributed to the UK?

Due to the Brexit, the question arises whether medicinal products have to be decommissioned in advance when distributed to the UK. Now, the European Commission has decided on a transition period for decommission with regard to exports to the UK.

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Janet Woodcock new FDA Acting Commissioner

When the new US President Biden took office, the previous FDA Commissioner resigned from his position. Now, Dr Janet Woodcock was named Acting FDA Commissioner.

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Revision of USP <661.1> Plastic Materials

The USP Packaging and Distribution Expert Committee intends to revise USP chapter <661.1> Plastic Materials of Construction. The targeted official date is 1 March 2021.

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Questions and Answers Document on Audit Alternatives of Notified Bodies

In a previous News you could read about audit alternatives of Notified Bodies in Covid-19 times. The guideline was based on a document of the Medical Device Coordination Group (MDCG). This guideline has now been supplemented by a question and answer document.

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Combination Products in the USA

Combination products in the US are separately regulated by the FDA via GMP regulations. A dedicated FDA website provides guidance on combination products. 

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Survey Results on "Remote Audits" of Notified Bodies

Within the framework of a survey via the EU Commission, Notified Bodies in the medical devices sector were asked about their experiences with "remote audits". The results are now available.

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Distant Assessment - an Option for the Future?

Due to the current pandemic and the associated restrictions, assessments are increasingly being performed remotely. Are these Distant Assessments also an option for the post-pandemic period?

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EMA: Updated Q&A documents on Centralised Procedures

The "Q&A" documents for centralised procedures were revised and published on the EMA website in January. In general, pre- and post-approval advices regarding centralised procedures are given and specially information for applicants of generic or hybrid medicinal products is mentioned. 

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Distribution of Temperature-Sensitive Pharmaceuticals: Requirements according to the EU GDP-Guidelines

With the approvals of various COVID-19 vaccines in many countries, the question arises how to safely transport the serum from the production sites to the storage and distribution centres and then on to the local vaccination centres. However, this question does not only arise for COVID-19 vaccines, but also any other temperature-sensitive product in general. The EU GDP-Guidelines contain some specific requirements for temperature-sensitive products in this regard.

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New MHRA Inspectorate Blog GDP Post: Be aware of Fake Websites when Qualifying New Customers and Suppliers Using Online Resources

Qualification and re-qualification of suppliers and customers are a fundamental part of Good Distribution Practice (GDP). Using online resources and publicly available databases is established as a standard requirement during this process. But relying (only) on information that is easily available to everyone may involve a high risk. In this context, a new post, entitled “Qualifications of suppliers and customers online: reliable or fake news?” has been published in the MHRA Inspectorate blog.

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Brexit Agreement - what now?

Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products?

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ICH Q9 Risk Management to be Revised

Since 2005, the ICH Guideline Q9 has been the state of the art when it comes to quality risk management (QRM) in the GMP environment. Now it is to be revised. What is planned?

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New Approach for Dissolution or Disintegration Tests in Ph. Eur. Monographs to be Published in Supplement 10.6.

A new policy for dissolution and disintegration testing in European Pharmacopoeia (Ph. Eur.) monographs has been adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form.

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FDA Warning Letter: No Adequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

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Non-Compliance Report for German Wholesale Distributor Published

The competent authority of Germany has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the discovery of serious GDP non-compliance at a German wholesale distributor.

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Still no remote FDA Inspections: Criticism grows

Since the beginning of the pandemic and the associated travel restrictions, the FDA has been hesitant to decide whether to conduct distant assessments. Now, more and more criticism is spreading.

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Avoiding Non-Compliance in Packaging Areas

Filling product into open containers with leaks above the packaging lines? Not a good idea - A current FDA Warning Letter provides information.

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Swissmedic clarifies Validity of GMP Certificates during the COVID-19 Pandemic

The Swiss Agency for Therapeutic Products Swissmedic has published a press release clarifying the validity of GMP certificates during the COVID-19 pandemic.

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Cloud Computing: Regulations for the Return Transmission of Data in the Event of Business Discontinuation

The issue of data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 10: What regulations must be in place to ensure that in case of business discontinuation (insolvency) of a cloud service provider, the data is completely returned to the client?

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UN Commission Reclassifies Cannabis

The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.

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EMA Distant Assessment Guidance

EMA has published a Guidance document, providing points for consideration relating to Distant Assessments.

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The Influence of Process Changes on Process Validation

What influence can process changes have on process validation? A current FDA Warning Letter provides information on this.

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Warning Letter due to Inadequate Pressure Stage Concept and Particle Monitoring

Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.

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Blind Trust in Supplier Certificates and Inadequate Final Testing - An Analysis of FDA Warning Letter

A look at the warning letters to pharmaceutical companies of the last nine months of the current fiscal year (Oct. 2019 - June 2020) shows the most frequent GMP violations found by FDA inspectors. Read more about the Warning Letter Analysis in this article of the GMP Journal

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