GMP News - APIs and Excipients

09.10.19

From Valsartan to Ranitidine: Nitrosamine Impurities and the Measures taken by the EMA and the EDQM

In June 2018, when it became known that the antihypertensive medicinal product Valsartan contained nitrosamines, no one had any idea how widespread these unwanted side-products were. Read more here to find out what action the EMA and EDQM have taken in the past and in response to the latest cases of nitrosamine contamination.

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02.10.19

FDA criticizes Lack of Compliance with ICH Q7 Guidance

According to the U.S. FDA, the Chinese firm failed to establish an adequate quality system and lacks quality oversight on documentation.

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02.10.19

FDA Guide for Non-clinical Studies of Oncological Therapeutic Radiopharmaceuticals

The FDA has published a final guideline for non-clinical studies of "Oncology Therapeutic Radiopharmaceuticals" to close the gaps in the existing FDA and ICH Guidelines.

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26.09.19

EDQM updates two Guidelines on the CEP procedure

The updating of two important documents by the EDQM reflects the current practice of the CEP procedure. Read more about the competencies and responsibilities of the various bodies in the CEP application procedure and about the code of practice for assessors and inspectors.

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26.09.19

Official Danish Cannabis-Monograph

Denmark has published its official pharmacopoeial monograph for Cannabis: Cannabisblomst (Cannabis flos).

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18.09.19

GMP for Radiopharmaceuticals - WHO/IAEA Guideline open for comments

In July, the WHO and the IAEA published a draft guideline for the specific GMP requirements for the manufacture and control of radiopharmaceuticals, which can be commented until 20 September.

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04.09.19

EMA publishes first two Guidances on Drug Shortages

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.

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29.05.19

WHO plans Inclusion of environmental Aspects in GMP

The WHO has published a draft document on "Environmental Aspects of GMP" and plans to include the topic of waste and wastewater management into GMP Guidance.

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10.04.19

EMA Guide on Sterilisation for Medicinal Products, API Excipients and Primary Packaging published

At the beginning of March, the EMA published a guideline for the sterilization of drugs, active ingredients, excipients and also primary packaging.

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03.04.19

Updated Information about the Risk of ZIKA Virus Transmission via Cells and Tissues

Based on the updated information from the CDC, the FDA pointed out the current risk assessment for the transmission of Zika virus through blood, cell or tissue products at the end of February.

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03.04.19

GMP for Cannabis - What is required?

More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?

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13.03.19

Is an Identity Test needed for the content of all Containers?

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

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06.03.19

WHO Recommends Re-Classification of Cannabis

After the legal situation for medical cannabis in Germany has already changed in 2017, the World Health Organization (WHO) has now proposed a global re-classification of the addictive potential of cannabis.

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27.02.19

EDQM updates Guidelines on the CEP Procedure

The EDQM has published four updated Public Documents on the revision, renewal or re-application of a CEP. Here you can find out what has to be considered when describing an API and its quality in a CEP application.

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20.02.19

EMA's Reflection Paper on the Qualification of Non-Genotoxic Impurities

Data from pre-clinical/clinical studies are often not sufficient for a comprehensive qualification of impurities with regard to their biological safety profile. The new EMA Reflection Paper provides guidance for determining the safety profile of impurities by means of various methods.

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