GMP News - Blood / Biologics and ATMP

21.07.21

The End for the Rabbit Test - only Alternative Methods in 5 Years

Following its 170th meeting the Commission of the European Pharmacopoeia announced that after a defined transition period the pyrogen rabbit test will be completely replaced.

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02.06.21

New USP Chapter on Visual Inspection of Parenterals?

In the current Pharmaceutical Forum PF 47(3), a Stimuli article describes the weaknesses in the current specifications for testing parenterals for particles and how these could be addressed in a new USP chapter.

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06.05.21

ATMP - Critical Deficiencies during an Inspection in the Netherlands

An inspection by the Dutch authority in February revealed a number of deficiencies at a manufacturer of advanced therapy medicinal products (ATMPs). The Non Compliance Report that was published shows which of these were critical.

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06.05.21

GMP for Advanced Therapies (ATMP) - Many Questions and some Answers

With the development of more and more guidance documents in the field of ATMP, new questions arise. The EMA has therefore published a Q&As paper on the GMP requirements for ATMPs.

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06.05.21

Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal Products

In order to take account of the rapid development in the field of biological medicinal products and ATMPs, the PIC/S has revised Annex 2 of its GMP Guideline and made it available for comment.

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11.03.21

COVID-19 Vaccines, Tests and Therapeutics - Recommendations for Handling Emerging Virus Variants

The new variants of SARS-CoV-2 are now occupying the minds of scientists around the world. The FDA is responding with a series of updated guidelines and recommendations for developers and manufacturers of vaccine tests and therapeutics.

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04.03.21

EMA Guidance on Adjusting Vaccines to COVID-19 Variants

Authorisation requirements for adjusted COVID-19 vaccines: the EMA publishes recommendations for vaccine developers and manufacturers.

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04.03.21

FDA's Strategies for Bacterial Safety of Platelets

In December, the FDA updated its guidance on bacterial safety strategies for platelets and platelet preparations, particularly in light of the current implementation difficulties faced by facilities under pandemic conditions.

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24.02.21

Inspection of biotechnological Manufacturers - PIC/S AiM Updated

In January, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire "Inspections of Biotechnology Manufacturers".

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23.02.21

25 Years Alternative Pyrogen Testing: Where do we stand? A Retrospect and Outlook

The EU demands to reduce animal testing or to avoid it altogether wherever possible. The pyrogen test on rabbits is therefore being replaced by MAT as an alternative in the EU. But how long has this taken and where is the journey going for alternative test systems in microbiology? A short review and outlook can be found here.

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04.02.21

CAT - Monthly Report on ATMPs

A regular insight and overview of the activities around ATMP in Europe is provided by the reports on the CAT meetings, which list the latest news on classification, authorisation and much more.

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04.02.21

FDA - Testing of Cells and Tissues Donors for Transferable Diseases

As a complement to the many guidances and documents on the development and manufacture of products from human cells and tissues, the FDA also provides an overview of strategies and approved tests for microbiological testing of donors of cells and tissues.

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04.02.21

Modern Vaccines and Platform Technologies - Explained in an Understandable Way

Questions reaching us on the subject of COVID-19 vaccines, their development, approval and production, and on modern platform technologies used are answered in a summary.

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08.12.20

FDA - Notification of Deviations in Cell and Tissue Products

An FDA document on Biological Product Deviation refers to products based on human tissues or cells.

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08.12.20

New FDA Guidance on Cellular and Tissue Products (HCT/Ps) published

During  2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

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