GxP Lifeline

Automating Document Control Processes to Comply with FDA and ISO Requirements

The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.

21 CFR Part 601 and Vaccine Approval

21 CFR Part 601 and Accelerated Vaccine Approval: Five Things You Need to Know21 CFR Part 601 Provides Basis for Accelerated Vaccine Approval

The AABB is Soliciting Public Comments From Blood/Biologics Industry

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

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

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

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 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

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

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

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

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.

Blood & Biologics Articles and Industry News Portal

Four Things You Need to Know About FDA's Guidance for Tissue Establishments

FDA Reminds Manufacturers About Their GTP Responsibilities

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

FDA Issues HCT/P Guidance

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

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.

5 Ways to Ensure System Compliance with 21 CFR Part 11 - MasterControl

Site Selection: Don’t Forget About the Study Drug

As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient data

Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.