Blood, Biologics and Tissue Industries Must Comply with Federal Regulations
Blood banks, transfusion centers, and tissue banks are covered by a number of regulations, including the Food and Drug Administration's (FDA) 21 CFR Parts 600, 606, 21 CFR Parts 210-211, 21 CFR Parts 1270-1271, 21 CFR Part 11 (for those maintaining electronic record-keeping systems), and the Clinical Laboratory Improvement Amendments (CLIA). In addition, many blood establishments affiliated with hospitals adhere to quality standards by the College of American Pathologists (CAP), a professional organization that provides voluntary accreditation.
The Center for Biologics Evaluation & Research (CBER) is the branch of FDA that oversees biologic products to ensure that they are safe for human use. These products include allergenics; blood; medical devices and tests used to safeguard blood and blood components; gene therapy; human tissues and cellular products; vaccines; and xenotransplantation products.
CBER inspects manufacturing plants before any of these types of products are approved and follows up with reviews on a regular schedule. CBER also inspects clinical study sites to ensure processes are properly executed and results properly conveyed.
International Regulation of Blood, Biologics and Tissue Products
The European Medicines Agency (EMA) is responsible for overseeing the safety and efficacy of blood, biologics and tissue products used to make medicines. Its Biologics Working Party (BWP) provides recommendations to the EMA's scientific committees on all matters relating to quality and safety aspects of biological and biotechnological medicines. The group also collaborates with the World Health Organization (WHO) on evaluation of medicines intended for markets outside of the European Union.
The World Health Organization (WHO) Blood Regulators Network (BRN) was established in 2006 and is comprised of leading international regulatory authorities that have responsibility for the regulation of blood, blood products and related in vitro diagnostic devices (IVD). The BRN focuses on scientific assessment of current and emerging threats to the safety and availability of blood and blood products. WHO publishes the "WHO Guidelines on Good Manufacturing Practices for Blood Establishments" (http://www.who.int/entity/bloodproducts/publications/GMP_Bloodestablishments.pdf).
In Australia, blood, blood components and plasma derivatives are regulated under the Therapeutic Goods Act 1989. Plasma derivatives are prescription medicines subject to full regulation under provisions requiring standards, licensing of manufacture and inclusion in the Australian Register of Therapeutic Goods (ARTG) after review of manufacturing, pre-clinical and clinical data. (http://www.tga.gov.au/industry/bt-blood.htm)
The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating all medicines in the United Kingdom, including blood and biologics. The Blood Safety and Quality Regulations 2005 No. 50 and The Blood Safety and Quality (Amendment) (No.2) Regulations 2005 No. 2898, became effective for the purposes of regulation on 8 November 2005.
ISBT 128 is the global standard for the terminology, identification, labeling, and information transfer of medical products of human origin (including blood, cell, tissue, and organ products) across international borders and disparate health care systems. It is used in more than 70 countries across six continents.
How MasterControl Can Help the Blood, Biologics and Tissue Industries
Because the safety of a nation's blood supply is so critical to the health of its residents, finding the right quality and document management system to maintain standards compliance is central to an organization working with it. And because profit margins are so slim, companies need these systems to help them function more efficiently and reduce wasted resources. Many blood, biologics and tissue companies, including hospitals, use MasterControl quality and compliance software to help companies achieve their quality and compliance goals.
MasterControl provides the foundation of a company's quality management system (QMS) by automating all documents- and forms-based processes, connecting all quality processes, and providing a Web-based, centralized repository for all documents that must be maintained according to regulatory requirements. MasterControl also offers two major advantages that set it apart from lesser QMS software solutions: cloud-based services and mobile access. MasterControl's cloud system provides a secure environment without requiring large up-front costs or excessive burdens on IT staff. Plus, users of the MasterControl system can perform tasks and access vital information using tablets or smartphones, thereby boosting their productivity and effectiveness.
The following MasterControl modules are particularly beneficial for companies striving to maintain compliance with standards in the blood, biologics and tissue industries:
MasterControl Documents™: MasterControl's document management software system is a comprehensive, market-leading solution that automates and accelerates the processes of changing, approving, notifying, and routing documents. It provides secure and sophisticated storage, versioning, metadata, security, retrieval, and indexing functionality and significantly reduces the time it takes to bring new products to market. The primary benefit of the MasterControl document management module is improved efficiency throughout the enterprise.
MasterControl Process™: Many manufacturers use MasterControl Process in conjunction with MasterControl Documents as the keystone of a robust QMS that spans the entire enterprise. MasterControl Process automates any forms-based process and offers best-practice forms that prompt users with selected data to reduce data entry and prevent common data-entry mistakes. It gives process designers the choice to configure all aspects of workflows, including users, tasks, tracking, escalation, and approval.
MasterControl CAPA and Quality Events Solutions: An effective corrective and preventive action (CAPA) software system like the solution offered by MasterControl™ improves product quality and safety, increases customer satisfaction, and, most importantly, ensures compliance with global ISO standards. MasterControl CAPA™ connects quality events such as nonconformance, deviations, and customer complaints and automates the management of the entire CAPA process, from initiation to investigation and all the way through closure. MasterControl CAPA and Quality Events solutions allow a CAPA form to be automatically launched from another form (such as a customer complaint) in order to streamline CAPA processes and avoid human data entry errors. Management is provided with a continuous, real-time overview of the CAPA process, which allows decision makers to be more proactive about improving the quality system.
MasterControl Nonconformance Management™: MasterControl nonconformance management software is a configurable and easy-to-use solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. MasterControl's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. MasterControl's nonconformance management software offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it. The software automates data collection, routing, follow-up, and escalation of nonconformance cases. The electronic "in" box tracks all active tasks for a user and provides tools for staying on top of things. Approvers can also review and sign electronically, shortening cycle time.
MasterControl Change Control™: MasterControl is an integrated change control solution that connects different departments with data and processes under a secure and centralized system. This connectivity vastly improves efficiency through automatic task assignment, routing, scheduling, notification, and escalation of incomplete tasks. MasterControl is Web-based, so even suppliers and others outside the company (off-site or traveling employees) who need to participate in change control can do so from virtually anywhere. It offers a best-practice form that incorporates priority level (by identifying the change as routine or temporary or emergency), as well as escalations. Plus, reports provide real-time status for all change control tasks.
MasterControl Training™: MasterControl Training automates the distribution and monitoring of training tasks to ensure competency across the enterprise. It provides the capability for online grading of tests and sequencing of courses. When a prerequisite course is completed within the MasterControl Training system, the next course in the sequence can be automatically instigated. MasterControl also offers a group sign-off feature for verifying trainings for large groups of employees.
MasterControl Audit™: MasterControl's audit solution automates all audit-related tasks and schedules. It enables manufacturers to deploy a single, flexible solution for ensuring quality and compliance across the enterprise. MasterControl Audit is cost-effective, easy-to-learn and use, and supported by IT departments and corporate management because it completely meets their needs. It also offers robust reporting tools and the capability to connect the audit management process with other critical quality processes.
MasterControl Deviation Management™: The deviation management software system from MasterControl automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. This solution provides the capability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement. It is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes. For example, deviation incidents can be correlated to nonconformance, CAPA, or customer complaints. MasterControl leverages the data collected for use in continuous quality improvement.
To learn more about Blood, Biologics and Tissue Industries
Contact a MasterControl representative for more information about the performance of MasterControl's QMS software solutions in blood, biologics and tissue environments,