GxP Lifeline

ISTB 128 Sets Industry Safety Standard

The key to satisfying these requirements lies in standardization: globally unique identifiers for products, standardized terminology and a means to convey information electronically that is recognized by computer systems throughout the world. Towards this end, ISBT 128 had been developed.

Increasing Efficiency Through Lean Principles

In today's economy many not-for-profit organizations have seen reserves eviscerated due to the stock market tumble. While the stock market has started to rebound, many not-for-profit agencies have also taken a hit on the philanthropic side. Donors are not able to be as generous as they have been in the past. The reserves that not-for-profits have been able to rely on to supplement operating funds are not there anymore. This has forced many organizations to look for other ways to reduce costs. W

FDA Guidance Pertaining to Certain HCT/Ps: Three Recommended Actions

FDA Issues HCT/P Guidance

Blood & Biologics Articles and Industry News Portal

What To Expect After an FDA Inspection

From blood supply to vaccines — blood establishments and biologics companies handle complex products that are fundamentally important to human life. It is no wonder that the industry faces some of the toughest regulations and standards today.

PFDA, Community Meets to Discuss Priorities Article

Reviews issues discussed during a recent meeting of FDA and blood community representatives where the two groups presented and reviewed issues important to their operations.On Oct 04, 2007, Food and Drug Administration (FDA) staff met with AABB’s FDA Liaison Committee in Bethesda, MD, to discuss topics of mutual concern in the areas of donor and patient safety. The committee includes liaisons from AABB, the American Red Cross (ARC), America’s Blood Centers (ABC), Advanced Medic

Editors Note - ISTB 128 Sets Industry Safety Standard

Robin Nozick wrote an article for the June issue of GxP Lifeline in which she erroneously referenced an unpublished version of the "ISBT Guidelines for Validation and Maintaining a Validated State in Blood Banking." Ms. Nozick regrets this mistake.

Blood Community Meets to Discuss Priorities

Clearly, there is no substitute for blood. There is no substitute for safety in handling blood, either. From donations at blood and tissue centers to transfusions in hospitals, the primary concern is for the purity of this life-giving fluid. The Food and Drug Administration (FDA) requires that blood establishments face some of the toughest regulations and standards today to ensure the safety of the blood supply.

FDA Reports That Majority of Biological Product Deviation in 2006 Was Related to Post-Donation Information

The FDA received 38,618 biological product deviation (BDP) reports for fiscal year 2006, 72 percent of which stemmed from donor-suitability problems that were not detected during initial donor interview.Of the total BDP reports, 27,427 were under the category of ?post-donation information? (PDI), which means donor-suitability problems were discovered only during subsequent interviews with donors, according to a report released by the FDA's Center for Biologics Evaluation and Research (CBER) in M

Designing a Learning and Performance Program in Tissue and Organ Banking

Keeping up with the changes and the training in tissue and organ banking is an ongoing process. We know what works well and what doesn't. We know with a field-based staff that classroom training is difficult to pull off when trying to coordinate everyone's schedules and of course working around the case load. What we have found is that online learning or on-demand learning does work. This allows all of the staff to access training when and where they need it. We currently offer the following typ

The Changing Face of Biobanks

Biobanking is changing rapidly, and it's in no small part due to the demands of systems biology. While small, university-centered banks have existed for decades, large-scale biobanks - whether tissue repositories or population databases - have recently been implemented all across the world. Many are also adding clinical annotation, genetic data, and increasingly genomic, proteomic, and other 'omics information. Population-wide biobanks exist in Iceland, the UK, Sweden, Canada, Estonia, Latvia, S

Blood & Biologics Lifeline - Health Canada Draft Guidance Issued in March

With Health Canada's recent publication of its draft guidance entitled, "Information and Submission Requirements for Subsequent Entry Biologics (SEBs)," the agency has initiated its plan to introduce a comprehensive regulatory, legal and scientific framework to approve biologic products that are similar to already approved biologics upon patent expiration. These products, also referred to as biosimilars by the agency, have posed a regulatory challenge for government agencies worldwide. The Europ

Blood Substitute's Effectiveness and Safety Addressed In Large Clinical Trial

A predicted shortfall of over 4 million units of blood worldwide is driving the need to develop an alternative to red blood cells.Academic and industry researchers participated in a Phase III multi-center clinical trial and found that use of a blood substitute was relatively safe in patients under 80 years old who have a moderate need for transfusion, up to the equivalent of three units of regular blood.Published in the June edition of the Journal of Trauma® this study is the first

Conferees Seek Paths to Improving Blood Center IT Systems

Blood community professionals and vendors met with officials from the Food and Drug Administration in a first-of-its-kind conference examining the impact of federal regulations on the development of donor and transfusion information technology (IT) systems.

Blood Center Accreditation by CAP Article

FDA-regulated blood centers, clinical laboratories, and related establishments are under tremendous pressure to maintain the highest standards for blood and tissue quality.

Blood Center Accreditation by CAP Can Boost FDA Compliance

FDA-regulated blood centers, clinical laboratories, and related establishments are under tremendous pressure to maintain the highest standards for blood and tissue quality.

Tracking Blood Electronically Article

Blood centers have been using reliable and easy-to-scan barcodes to positively identify and track blood products for decades. Radio Frequency Identification (RFID) technology has been widely used in other industries with myriad applications for years. Marrying the two technologies for transfusion medicine can make it possible to "read" containers of blood simultaneously, reduce costs, streamline operations, and ultimately prevent mismatched blood at the point of transfusion. The addition of RFID

Blood & Biologics Article - Preparing For EU Assessment

By Becky SeeDiscusses how a U.S. blood center should prepare for an EU inspection.A safe and adequate blood supply is essential to the practice of modern medicine. New advances, particularly in the area of automation, have enhanced both safety and blood availability on an international scale.  Sovereign countries formerly looked to their own citizens for their blood plasma needs; today, plasma is an international commodity and as such, its collection centers are assessed by European a

U.S. Biovigilance Network: Hemovigilance System

AABB, formerly the American Association of Blood Banks, and the Department of Health and Human Services have partnered to develop the U.S. Biovigilance Network. This network will, for the first time on a nationwide basis, collect and analyze data to identify trends and recommend best practices to reduce adverse reactions and incidents associated with blood transfusion and related biological therapies. Ultimately, the analyses of this data will enhance patient safety, make better use of blood and

The AABB is Soliciting Public Comments From Blood/Biologics Industry