GMP News - Blood / Biologics and ATMP

08.02.22

FDA Q&A Guidance on the Implementation of a Pathogen Reduction System for Blood Products

With the final publication of a guidance document on the implementation of a pathogen reduction system for blood components, the FDA complements its guidance documents on blood, blood products and plasma.

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08.02.22

FDA sends once again Untitled Letter to Manufacturers of Regenerative Therapies

With an "Untitled Letter" the FDA addresses again a manufacturer of regenerative therapies that does not meet the appropriate requirements for marketing such a product.

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05.01.22

Requirements for Plastics in Pharmaceutical Equipment Engineering

Stainless steel is predominantly used in pharmaceutical equipment engineering. The 316L variant is basically regarded as standard; material incompatibilities of the steel with the product are more or less neglected. This is different with plastics. In addition to leach-out, aging and surface finish, other quality characteristics are often specified. But are there generally applicable requirements for plastics in pharmaceutical equipment engineering?

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22.12.21

FDA publishes Draft Guidance on Visual Inspection of Parenterals

It has been known for some time that the US FDA is working on its own guide on the visual inspection of parenterals. Now the draft has been published as a 15-page document.

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21.12.21

COVID-19 Vaccines - Inspections under Emergency Approvals in the US

The GAO report details the number and frequency of FDA inspections of Covid-19 vaccine manufacturers and other biopharmaceutical manufacturers during the pandemic period.

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21.12.21

WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies

In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.

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21.12.21

Regenerative Medicine Advanced Therapy (RMAT)- FDA explains which products fall under "RMAT"

By providing clarification on the designation "Regenerative Medicine Advanced Therapy" , the FDA is providing more clarity on which products may fall in this classification.

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29.09.21

New FDA Q&As on Endotoxin Testing

As part of its Q&A series, the FDA has published a draft guidance on various quality topics, including questions on endotoxin testing.

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25.08.21

Dealing with Particulate Findings in 100% Visual Inspection

Parenterals must be 100% visually inspected. This is a clear requirement of the pharmacopoeias, just as it is clear that containers with particles must be sorted out. But do the particles found always have to be identified?

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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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