GMP News - Blood / Biologics and ATMP

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.

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Related to the necessary assessment of environmental impacts, the FDA published a Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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05.12.13

FDA: Draft Guidance for Industry: Donor Testing for Evidence of Infection with Treponema pallidum (Syphilis)

With the Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis), the FDA provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. Read more.

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05.12.13

FDA Science and Research: Keeping stored platelets free of bacteria

Scientists at the US Food and Drug Administration (FDA) have demonstrated in animal studies a proof-of-concept approach that might reduce the bacterial burden of room temperature stored human platelets. For more details read here.

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05.12.13

Recommendations for Premarket Notification Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Transfusion and Transplantation

Most cells of the body bear human leukocyte antigens which allow the human immune system to distinguish the body’s own blood, organs and tissues from foreign substances. Related to test kits for these HLA, the FDA published a Draft Guidance with recommendations for premarket notification submissions. Read more here.

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19.09.13

World Health Organisation (WHO) continues successful collaboration with Paul-Ehrlich-Institut

WHO and PEI - eight years of successful cooperation for Quality Assurance of Blood Products and in vitro Diagnostic Devices. Read more here.

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19.09.13

EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

In May, the Committee for Medicinal Products for Human Use (CHMP) adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. Read more.

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19.09.13

Draft Guidance with Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

Referring to the increasing need of Cellular and Gene Therapy products, the FDA published a daft guideline "Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products". More details can be found here.

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