21 CFR Part 606 outlines the Current Good Manufacturing Practice (CGMP) requirements for blood establishments. 21 CFR 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 blood-related Compliance Program that inspections must be conducted to verify that blood establishments meet process and production controls, equipment regulations, and quality assurance requirements found in 21 CFR Part 211
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The U.S. Food and Drug Administration (FDA) CGMPs establish a system for ensuring that medical products are produced consistently and according to applicable quality standards based on their intended use and as required by product specifications. These guidelines are in place to prevent the occurrence of adverse events by ensuring product safety, potency and efficacy.
As they pertain to blood and blood components specifically, the CGMPs in 21 CFR Part 606 aim to minimize the transmission of bloodborne diseases. Adhering to CGMP requirements throughout the entire blood production process – spanning from donor to recipient – is essential to consistent blood product quality and safety. Examples of blood collection and production activities governed by CGMPs include: applying the appropriate donor selection criteria; preventing errors during testing; and supporting traceability with adequate documentation of each step in the process.
21 CFR 606.20 – Personnel:
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 safety, purity, potency, identity and effectiveness it purports or is represented to possess.
21 CFR 606.100(b) – Standard operating procedures:
Written standard operating procedures (SOPs) must 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 must be available to the personnel for use in the areas where the procedures are performed.
21 CFR 606.140 – Laboratory controls:
Laboratory control procedures shall include adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments.
21 CFR 606.170 – Adverse reaction file:
Records shall be maintained of any complaints of adverse reactions that result from blood collection or transfusion. A thorough investigation of each reported adverse reaction shall be made. 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.
21 CFR 606.171 – Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services:
21 CFR Part 606 does not use the term corrective and preventive action (CAPA), but section 606.171 states that all biological product deviations should be investigated in accordance with the applicable provisions of 21 CFR Parts 211 and 820, both of which require the establishment of CAPA procedures.
Compliance Program for Blood and Blood Components Guidance Manual-7342.001, Attachment B – Product quality review:
A review of records must be conducted at least annually to evaluate the quality standards of each product and to determine if there is a need for changes in product specifications or manufacturing or control SOPs (21 CFR Part 211.180(e)). SOPs for this review must be in writing.
CGMPs apply to all regulated manufacturers of medical products intended for human consumption or use. By establishing minimum requirements for the methods, facilities and controls used in manufacturing, processing and packaging, CGMPs intend to ensure the safety and quality of pharmaceuticals, medical devices, biologicals and other regulated products. The FDA conducts routine inspections of blood establishments to ensure compliance with 21 CFR Part 606 CGMP requirements for blood and blood components. Depending on their intended use, these products can be classified as either drugs, devices or combination products, so additional regulations may apply.
In the following ways, MasterControl’s configurable, easy-to-use and integrated suite of solutions addresses the CGMP requirements in 21 CFR Part 606:
MasterControl quality and regulatory software offers blood companies the robust and compliant functionality they need to comply with 21 CFR Part 606 and additional regulations set forth by the FDA and other global regulatory bodies. Across all regulated industries, MasterControl is the software of choice for thousands of companies wishing to achieve more consistent and reliable CFR compliance with greater efficiency, allowing them to bring their life-changing products to market sooner.
MasterControl and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).
For more information on how MasterControl software and services can help your company improve efficiency while achieving FDA compliance, contact a MasterControl representative.