GMP News - Quality Assurance

24.02.21

FDA stops Hand Sanitizers with too low Alcohol Content at the US Border

The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product labeled as containing 75% ethanol, but in fact contained only 58%, was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.

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23.02.21

Can the Water Activity Test replace Microbial Testing?

According to the USP no microbiological testing of low water activity pharmaceutical products may be needed after a comprehensive risk assessment. The USP therefore revised the general chapter <1112> Role of Water Activity in Microbial Risk Assessment of Nonsterile Pharmaceutical Products.

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17.02.21

EMA Clarifies GMP Requirements for Herbal Substances Used as APIs

When does EU GMP Guide Part II apply to the manufacture of herbal extracts? A new EMA Q&A document on GMP for herbal extracts used as active substances in herbal medicinal products gives the answer to this question.

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17.02.21

GAO criticizes FDA's current Inspections Approach

In a report published end of January, the U.S. Government Accountability Office (GAO) asks the US Food and Drug Administration (FDA) to review its inspections approach during the pandemic.

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17.02.21

Brexit Guideline from CMDh updated

The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit.

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17.02.21

FDA Applications during Covid-19: better Communication planned

With an updated Guidance document, the US Food and Drug Administration (FDA) plans to improve communication with industry.

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16.02.21

Updated Guidance on the Management of Clinical Trials during COVID-19

Pragmatic procedures are currently required to ensure the flexibility needed to maintain the integrity of clinical trials during the COVID-19 pandemic. The updated guidance on management of clinical trials during COVID-19 includes adapted approaches for IMP supply and details on remote source data verification.

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16.02.21

Updated Timeline for the Clinical Trial Regulation

The EMA is still planning with January 2022 as the date for the first application of the Clinical Trial Regulation (CTR). Initial information on the schedule was published in December.

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10.02.21

FDA Plans for new (GMP) Guidance in 2021 - CDER provides Information

What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evaluation and Research (CDER) in their list of planned and / or to be revised guidance documents. On five pages, comprising 18 individual categories, these documents are presented.

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03.02.21

EU plans new Health Authority

The European Commission is planning to create a new EU Health Emergency Preparedness and Response Authority (HERA). For this purpose, the Commission has opened a feedback procedure.

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03.02.21

PMDA publishes Remote Inspection Guidance

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published an English version of a Procedure for Remote Inspections.

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03.02.21

Are QP Remote Certifications allowed?

We keep receiving questions about the extent to which remote QP certifications are possible in the current situation. Unfortunately, the legislation in the individual EU Member States is not uniform.

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03.02.21

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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27.01.21

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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27.01.21

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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