GMP News - Blood / Biologics and ATMP

20.01.15

Human Cells, Tissues or Cellular- or Tissue-based Products - Exception from the Requirements under Part 1271

The US FDA published a draft guideline on Same Surgical Procedure Exception under 21 CFR 1271.15, related to human cells, tissues or cellular or tissue-based products. Read more here.

more

20.01.15

FDA finalizes Guidance for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

In December 2014, the Food and Drug Administration, Center for Biologics Evaluation and Research published the guidance on "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture". Read more here.

more

20.01.15

FDA Draft Guidance for initial testing for bacterial contamination of platelets published

With regard to Testing of Blood Platelets for Bacterial Contamination the US FDA has published a Draft Guideline. Read more here.

more

20.01.15

FDA publishes Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products

The FDA has published a Draft Guideline with recommendations for human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff  for the criterion of minimal manipulation. Learn more.

more

11.08.14

EMA: Concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus

The European Medicines Agency (EMA) published a concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus and wants to organise a workshop to address the relevant issues. Read more.

more

11.08.14

Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

The US FDA published a revised Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. Mere details can be found here.

more

11.08.14

Uniform Blood and Blood Component Container Labels

After a request of the International Council for Commonality in Blood Banking Automation, the FDA published a Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels. Get more details.

more

11.08.14

Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

Related to the necessary assessment of environmental impacts, the FDA published a Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products. Read more here.

more

21.03.14

New Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood

On 6 March, the CBER published a new guideline for Industry as well as for FDA staff related to the Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood.

more

21.03.14

BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood

On 5 March, CBER published the new guidance document about Biologics License Applications... read more.

more

21.03.14

Detailed Analysis of Annex 15 Draft

A new era has begun with the publication of the draft on the revision of Annex 15 (Validation/ Qualification) with regard to validation. The volume has grown from 11 to 17 pages. A few new chapters have been added, whereas much familiar information is missing. You will find a detailed analysis in the News.

more

20.02.14

PIC/S GMP Guideline - Revised Annex 2 for biological Substances and Products adopted

On 1 March, the new Annex 2 of the PIC/S GMP Guide (PE 009-11) will become effective. Read more about the revised Annex here.

more

20.02.14

PIC/S revises Annex 14 for Medicinal Products derived from Human Blood or Plasma

On 31 January 2014 the PIC/S Committee has adopted  the revision of the PIC/S GMP Guide (PE 009-11). The revised GMP Guide will enter into force on 1 March 2014. Find here more details.

more

20.02.14

Good Practice Guidelines for Blood Establishments as a Co-Operation between the EDQM/CoE and the EU Commission published

The EDQM and the Commission of the European Union published "Good Practice Guidelines for Blood Establishments and Hospital Blood Banks Required to Comply with EU Directive 2005/62/EC”. Read more here.

more

23.01.14

How to submit an Active Substance Master File?

The Active Substance Master File (ASMF) describes the quality of an API and is an essential document for the marketing authorisation of medicinal products. The procedure to submit an ASMF has been recently updated and described extensively in a new EMA Q&A document. Read more about the newest provisions.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics