GMP News - Blood / Biologics and ATMP

21.04.22

Genome Editing in Gene Therapy - FDA Draft Guidance for IND

Gene therapies are becoming increasingly important. One method is the so-called genome editing. The FDA has published a draft guidance for Investigational New Drugs (IND) for these Gene therapy products.

21.04.22

FDA updates Information on Bacterial Contamination of Platelets for Transfusion

In December, the FDA updated its important information for blood establishments and transfusion services on bacterial contamination of platelets for transfusion, which has been published since 2016.

23.03.22

ECA comments on FDA Guideline on Visual Inspection

In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.

17.02.22

Final EMA Guidelines on Quality Requirements for IMPs

The final EMA Guidelines on the quality requirements for IMPs (pharmaceutical and biopharmaceutical drugs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. Many of the comments related to the question "What is a Non-substantial Modification?".

08.02.22

FDA Guidance on CMC Change Management for Biologics and Notifications published

In December, the FDA published the final version of its "CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports" guidance, which addresses the reporting required for changes in the chemistry, manufacturing or controls of an already approved biological product.

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.

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.

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?

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.

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.

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.

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.

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.

31.08.21

FDA admonishes Regenerative Therapies Manufacturer in Untitled Letter

In an "Untitled Letter", the FDA requests information from a manufacturer of regenerative therapies based on umbilical cord stem cells on the approval status of the products distributed and used.

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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GMP News - Blood / Biologics and ATMP

Genome Editing in Gene Therapy - FDA Draft Guidance for IND

FDA updates Information on Bacterial Contamination of Platelets for Transfusion

ECA comments on FDA Guideline on Visual Inspection

Final EMA Guidelines on Quality Requirements for IMPs

FDA Guidance on CMC Change Management for Biologics and Notifications published

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

FDA sends once again Untitled Letter to Manufacturers of Regenerative Therapies

Requirements for Plastics in Pharmaceutical Equipment Engineering

FDA publishes Draft Guidance on Visual Inspection of Parenterals

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

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

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

New FDA Q&As on Endotoxin Testing

FDA admonishes Regenerative Therapies Manufacturer in Untitled Letter

Dealing with Particulate Findings in 100% Visual Inspection

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