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Guidance for Treponema pallidum Screening of donors of Human Cells and Tissues (HCT/Ps)

End of 2015, the FDA finalized their draft document and issued the Guidance for Industry "Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)".

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FDA Recommendations: Reducing the Risk of HIV Transmission by Blood and Blood Products

The FDA adopted and published the Guidance for Industry "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products". Read more about these FDA recommendations.

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Pharmeuropa - Comments concerning revised texts about Bacterial Endotoxins

In December the EDQM published the comments concerning revised texts of chapter 5.1.10. Guidelines for using the Test for Bacterial Endotoxins. Find out more about the scope and the added specific points in the Test for Bacterial Endotoxins Guideline.

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FDA Guidance finalised: Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

On 17 August, the FDA published the finalised Guidance for Industry and Food and Drug Administration Staff  "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices".

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Revised Draft of Pharmeuropa Monograph 5.1.2. Biological Indicators

End of 2011 the Pharmeuropa 24.1 published a first draft of the monograph "5.1.2. Biological Indicators in the Preparation of Sterile Products" for discussion. Due to the abundance of comments, the draft was substantially revised and is now available in the Pharmeuropa 27.3 for comments again. Read more about the current Draft 5.1.2. Biological Indicators.

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FDA Guidances - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products

Establishments that manufacture human cells, tissues, and cellular and tissue-based products have to comply with a number of requirements under Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271). This includes Investigating and reporting adverse reactions.

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Blood - Revised Recommendations for Reducing the Risk of HIV Transmission

With the new draft the US FDA wants to replace the guidance document "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," issued in 1992. Learn more about the draft Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.

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Contamination Control - Still an issue during inspections

Measures for contamination control are one of the basic requirements for the manufacturing of medicinal products. Still, contamination control issues got back in the TOP TEN List of 21 CFR 211 Citations. Read more about contamination control as an issue during inspections.

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Ozonization of Pharmaceutical Water and the Biocidal Products Regulation

With the new biocidal products regulation from 2013 in-situ generated ozone now also falls into the scope of this directive. Ozone generation systems with a biocide application (such as disinfection of pharma water) thus require an approval after the transitional period expires in the September 2017. The ozone registration group is active for this purpose. Read more about the Ozonization of Pharmaceutical Water and the Biocidal Products Regulation.

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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.

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