FDA 21 CFR Part 606

Companies that handle blood and blood components must comply with 21 CFR Part 606 current good manufacturing practice (CGMP) guidelines.

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.

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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:

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.
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.
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.
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.
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.
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

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The FDA inspects all blood facilities at least every two years. “Problem” facilities with inefficient processes are audited even more often. When processes and data are integrated within a digital platform, auditable records are just a mouse click away. And nothing takes the sting out of audits like auditors getting exactly what they want, when they want it.

Keep SOPs Controlled and Up to Date

FDA warning letters. Harsh penalties. Costly product recalls. They’re all likely outcomes for blood companies whose SOPs are outdated or inconsistent with regulations. Companies can eliminate inefficiencies by replacing paper-based SOPs and work instructions with document management software expressly built for life sciences companies.

Ensure Training Compliance

Part 606 requires personnel who handle blood or blood components to be adequately trained and able to perform assigned tasks per regulatory guidelines. A digitized training management system helps ensure current training for all employees. It also guarantees that training records are appropriately tracked and accessible.

Effectively Track Deviations and Nonconformances

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CGMPs require blood companies to take effectual remedial actions. But managing quality events is always a complicated endeavor. Robust software improves visibility into quality events and makes them easier to identify, address and document.

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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FDA 21 CFR Part 606

Compliance Videos

Free Compliance Resources

CGMP Guidelines for Blood Establishments

Key Requirements of 21 CFR Part 606

Personnel (Part 606.20):

Equipment (Part 606.60):

Standard Operating Procedures (SOPs) (Part 606.100):

Records (Part 606.160):

Adverse Reaction File (Part 606.170):

Reporting of Product Deviations (606.171):

CGMP Requirements

Digitization Is the Key to Streamlined CGMP Compliance

Ensure CGMP Compliance With MasterControl

Compliance doesn’t have to be painful.

Corrective Action Preventive Action (CAPA)

Current Good Manufacturing Practices (cGMP)

Quality Assurance (QA) Software Systems