GMP News - Blood / Biologics and ATMP

08.06.22

USP publishes Draft Guideline on Analytical Methods for mRNA Vaccines

At a time of increased interest in mRNA-based medicinal products and vaccines, the USP has published for comment a draft guidance document on "Analytical Methods for the Quality of mRNA Vaccines".

more

18.05.22

PharmEuropa - Revision of Chapter 2.6.30 Monocyte Activation Test

After the revision in 2017, the Monograph 2.6.30. Monocyte Activation Test in the European Pharmacopoeia undergoes a new revision which is open for comments until the end of June.

more

11.05.22

How to Demonstrate Comparability of Analytical Procedures

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.

more

04.05.22

Bioburden - Question and Answers on Biopharmaceutical Manufacturing

Questions - and answers about Bioburden. A first excerpt of the most important questions during the ECA Bioburden Workshop.

more

27.04.22

Revision of Chapter 2.6.7 of the European Pharmacopoeia published for Comment

After about 10 years, the EDQM has now published a draft revision of Chapter 2.6.7 on mycoplasma testing, which will be available for comment until the end of June.

more

21.04.22

FDA Guidance for Chimeric Antigen Receptor (CAR) T Cell Products

With a draft guidance for the development, manufacture and control of chimeric antigen receptor (CAR) T cell products, the FDA is expanding its recommendations for advanced biological products and providing further guidance to developers and manufacturers.

more

21.04.22

FDA revises Recommendations on Investigational COVID-19 Covalescent Plasma

The FDA has already updated its recommendations on handling plasma donations from COVID-19 diseased donors several times. Recently, a new update of the Guidance for Industry Investigational COVID-19 Convalescent Plasma was published.

more

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Genome Editing in Gene Therapy - FDA Draft Guidance for IND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 The FDA has published a draft guidance for Investigational New Drugs (IND) for these Gene therapy products.

more

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.

more

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.

more

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?".

more

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.

more

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.

more

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.

more

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?

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics