FDA 21 CFR Part 606
The 21 CFR Part 606 regulation establishes CGMP requirements for blood and blood components. Its aim is to ensure quality in blood banks and other organizations that process blood products. Its guidelines help them appropriately manage records, reports, labeling, equipment, facilities, personnel and controls for production, processes and laboratories. It is enforced by the Center for Biologics Evaluation and Research (CBER), a division of the U.S. Food and Drug Administration (FDA). Process automation simplifies compliance with Part 606 and gets blood and related products to patients sooner.
Free Compliance Resources
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CGMP Guidelines for Blood Establishments
The safety of recipients and donors is the top concern of any organization that processes blood and blood components. The CGMPs outlined in 21 CFR Part 606 exist to uphold the consistent safety and quality of blood products. They’re intended to improve performance in such areas as documentation, production and process controls and error prevention during testing. Adherence to the CGMPs decreases the likelihood of adverse events. It also helps companies ensure product safety, efficacy and compatibility.
Key Requirements of 21 CFR Part 606
To meet Part 606 requirements, blood companies must accurately and precisely manage their processes and data. The following key aspects of Part 606 compliance are easier to manage when digitized:
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Personnel (Part 606.20):
All personnel who collect, process, test, store or distribute blood or its components must be sufficiently trained. An automated training management system helps assure competency. Digitized training processes reinforce the safety, purity, potency, identity and effectiveness of blood products.
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Equipment (Part 606.60):
Any equipment used in blood collection, processing, compatibility testing, storage and distribution must be maintained in a clean and orderly manner. It must also be observed, standardized and calibrated on a regularly scheduled basis. Software specifically designed for equipment maintenance and calibration management streamlines these efforts.
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Standard Operating Procedures (SOPs) (Part 606.100):
Written SOPs must be continually maintained for processes involving blood transfusions and “further manufacturing purposes.” They should outline every step of collection, processing, compatibility testing, storage and distribution activities. Document management software keeps SOPs up to date and aligned with regulations.
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Records (Part 606.160):
Records must be maintained concurrently with the performance of each significant step of blood processing. The documentation must accurately capture entry dates, the person performing the work and a complete history of the work performed. An electronic solution enables companies to securely store all compliance records within a single system.
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Adverse Reaction File (Part 606.170):
Records must be maintained for any complaints of adverse reactions to a blood product. A thorough investigation of each known adverse reaction must also be reported. Purpose-built complaint management software simplifies the handling and investigations of these events.
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Reporting of Product Deviations (606.171):
Deviations from CGMPs may affect the safety, purity or potency of blood products and therefore must be reported to CBER. It is easier to electronically file the required Form FDA 3486 when all deviations data is maintained within a single digital system. Launching corrective and preventive actions (CAPAs) in response to deviations is also a smoother process when the information is connected in a digital platform.
CGMP Requirements
CGMP compliance hinges on control over quality. Blood organizations must be able to provide evidence to the FDA that CGMP guidelines are being followed. Companies must show that the quality, safety, purity and potency of their products is continually maintained. Automated quality processes increase the efficiency of CGMP compliance activities while driving down overall costs. Automation also allows companies to maintain a continual state of audit readiness.
Digitization Is the Key to Streamlined CGMP Compliance
Maintain Continual Audit Readiness
Keep SOPs Controlled and Up to Date
Ensure Training Compliance
Effectively Track Deviations and Nonconformances
Ensure CGMP Compliance With MasterControl
MasterControl has been the software of choice for hundreds of life sciences companies for more than 25 years. Our integrated quality solutions give blood companies the capabilities needed to meet regulations like 21 CFR Part 606. Companies that strive to consistently maintain compliance digitize processes with MasterControl.
Compliance doesn’t have to be painful.
Digitized quality processes take the trauma out of CGMP compliance.
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