21 CFR Part 606

21 CFR Part 606 CBER CGMP Regulations to Ensure Quality in Blood Banks or Blood-Related Establishments

21 CFR Part 606 outlines the Current Good Manufacturing Practice requirements for blood establishments. 21 CFR Part 606 was designed and is used to ensure that blood and blood components for human use are safe, pure, and effective. The Center for Biologics Evaluation and Research (CBER) also specifies in its Compliance Program that inspections are conducted to make sure that blood establishments meet process and production controls, equipment regulations, and quality assurance requirements found in 21 CFR Part 211.

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MasterControl Inc. has designed a configurable, easy-to-use, and integrated software solution to help companies comply with 21 CFR Part 606 and other FDA regulations. Here's how the MasterControl™ quality management suite addresses CGMP requirements found in 21 CFR Part 606 (an * denotes a requirement related to Part 606):

21 CFR Part 606 Requirements

MasterControl Features

Sub Part F, Section 606.10, b

Written 21 CFR Part 606 standard operating procedures shall be maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes. Such procedures shall be available to the personnel for use in the areas where the procedures are performed.

MasterControl Documents automates routing, escalation, approval, and delivery of SOPs, policies, and other documentation. Provides a centralized Web-based repository that's secure, but at the same time accessible to all authorized users. MasterControl provides automatic revision control to ensure that only the current version of an SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports which helps in maintaining 21 CFR Part 606 compliance.

Sub Part B, Section 606.20

The personnel responsible for collection, processing, compatibility testing, storage or distribution of blood and blood components shall be adequate in number, educational background, training and experience, including professional training as necessary-to assure competent performance-and to ensure that the final product has the purity, safety, potency, identity and effectiveness it purports or represent to possess.

MasterControl Training automates assignment and monitoring of training tasks and grading of online exams. Allows sequencing of training courses, so after a prerequisite is completed, the next course is automatically launched which keeps the process according to 21 CFR Part 606 requirements. Provides group sign-off feature for verifying training of large groups of employees.

Sub Part I, Section 606.170

Records shall be maintained of any complaints of adverse reactions-as a result of blood collection or transfusion. A thorough investigation of each reported adverse reaction shall be made to ensure 21 CFR Part 606 compliance. A written report of the investigation-shall be prepared and maintained as part of the record for that lot or unit of final product by the collecting or transfusing facility.

MasterControl Customer Complaints streamlines the 21 CFR Part 606 complaint handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue res olution. Includes the FDA's MedWatch 350A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist while ensuring that required data is immediately collected.

Sub Part H, Section 606.140

Adequate provisions for monitoring the reliability, accuracy, precision, and performance of laboratory test procedures and instruments.

The 21 CFR Part 606 Compliance Program for Blood and Blood Products (Attachment A), states the importance of auditing the efficiency of a QA program in the ""Manufacturers Audit of Quality Assurance"" section.

One of the best ways to monitor and document the reliability and accuracy of laboratory test procedures is through quality audits. MasterControl Audit automates, streamlines, and effectively manages the audit process. Provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms for tracking basic audit information and audit findings which are compliant with 21 CFR Part 606 standards. Automates scheduling of all recurring audit-related activities and provides analytics and reporting capability for Increased Management Visibility.

Section 606.171

21 CFR Part 606 does not use the term ""corrective and preventive action,"" but Section 606.171 states that all biological product deviations should be investigated in accordance with the applicable provisions of Parts 211 and 820. Both Parts 211 and 820 require establishment of CAPA procedures.

MasterControl CAPA integrates the corrective and preventive action process with other quality processes. Provides best-practice ""8D"" process that guides the quality team through every step of CAPA sustaining a compliant process with 21 CFR Part 606. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.

Annual Evaluation

Written records-shall be maintained so that data therein can be used for evaluating, at least annually, the 21 CFR Part 606 standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations.

MasterControl Change Control streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change is likely to require 21 CFR Part 606 regulatory filing. Customizable reports provide real-time status of change control tasks and the entire quality system.

Compliant - Sustained Compliance with 21 CFR Part 606

MasterControl is compliant, helping you meet 21 CFR Part 606 and other FDA regulations year after year, while keeping compliance costs down.

Connected - Integrated 21 CFR Part 606 Quality Management Suite

MasterControl is connected, giving you the ability to monitor the entire quality system and continuously improve it.

Complete - Enterprise-wide 21 CFR Part 606 Application

MasterControl is complete, meeting every department's needs to ensure that quality initiatives are enforced across the enterprise.