GMP News - Blood / Biologics and ATMP

16.02.23

Transmission of Malaria by Blood Donors - FDA updates Guidance Document

As a result of the specifics of the pandemic situation over the past two years, the FDA is issuing an update to its recommendations for reducing malaria transmission during transfusions. It replaces the April 2020 guidance.

more

16.02.23

FDA Information on bacterial Contamination of Platelets for Transfusion

After 2019 and 2021, the FDA will again update its findings and recommendations regarding bacterial contamination of platelet preparations for transfusion purposes.

more

16.02.23

Pyrogenicity Testing - European Pharmacopoeia continues to be updated

The European Directorate for the Quality of Medicines published a new chapter 5.1.13. PYROGENICITY, dealing with testing for pyrogens, for comment.

more

15.02.23

The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

more

25.01.23

ICH M10 Guideline on Bioanalytical Method Validation and Study Sample Analysis

The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.

more

26.10.22

ICH Q5 A (R1) Revision: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

In October, the EMA published a revised version of "ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" for consultation.

more

26.10.22

Warning Letter in the Area of Allogenic Umbilical Cord and Amniotic Membrane Products

During an inspection at the end of 2021, the FDA identified a manufacturer of umbilical cord blood products as lacking approval as well as numerous deviations with regard to common GMP requirements.

more

18.08.22

CMC: FDA publishes Guideline with questions on post-approval modification of single-use materials

With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).

more

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

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics