GxP Lifeline

QMS Pains in the Blood and Biologics World

Maintaining a quality system within a blood and biologics organization is a very resource-intensive endeavor. Changes resulting from new regulations, new and updated procedures, new techniques, changes in suppliers and supplies, new and enhanced safety practices, and the like, all result in a massive amount of change that must occur across the organization. Managing these changes in turn requires the assignment of multiple resources across multiple areas of an organization. These are just the qu

HCT/P Inspections: Most Common Deviations

Total of 36 Product Recalls Last Year for HCT/P Sector

Stop the Madness! Process Control Essentials for Effective Continual Improvement

It is a dark and stormy night. Your facility is readying for what promises to be a challenging third-party review. You, the Quality Manager, along with your organization's General Manager, are reviewing a variety of the process monitoring data reports to prepare for the upcoming "grilling." One such report provides information regarding response times to the central monitoring alarm system, specifically for the reagent storage refrigerator.

The Value of Performing a Good ValidationIn Transfusion Medicine

The blood establishment bears the responsibility for the regulatory compliance of the automated/computerized systems used. Full validation of the computerized system is required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control). The Quality Risk Management approach to validation advocated by GAMP 5 and ICH Q9, a life cycle approach within the QMS, and the use of risk assessments to define the validation strategy for

Minimizing the Risk of Donor Disease Transmission

Each year in the United States, nearly 30,000 people receive the opportunity to save, extend or enhance their lives through the human gift of organ donation. Of those, roughly three-fourths of the organs transplanted come from deceased donors.

A Myriad of Documents - Is there Control?

Document control is an issue for every laboratory. The words in the requirements seem so simple: control your documents. How can so much effort be involved in three words?

Blood Bank ISBT 128 Implementation - Blood Industry

My own blood bank's ISBT implementation was not quick or easy. If I could do everything again, I would do things quite differently. Hopefully a review of my own mishaps will help you plan your own ISBT implementation more effectively.

Legal Risks Affecting Blood Banks

Blood banking is a high risk business. Some risks are obvious; others are not well understood. This article is by no means a comprehensive analysis of risks affecting blood banks. It identifies certain high risk areas and makes recommendations about risk mitigation, but is not intended to provide legal advice.

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