Description
We, FDA, are issuing this guidance document to provide you, blood establishments, with recommendations for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. We also provide information to licensed blood establishments for submitting biologics license application supplements to include leukocytes reduced components. This guidance applies to Whole Blood, Red Blood Cells, Plasma, and Platelets1manufactured from Whole Blood or collected by automated methods2. This guidance document finalizes the draft guidance of the same title dated January 2011 and supersedes the FDA memorandum issued on May 29, 1996, entitled Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products.
Scope & Applicability
Product Classes
10Blood component subject to the recommendations in this guidance
Specific blood component category
Manufacturing of leukocyte reduced products
Leukocyte reduced plasma products
Leukocyte reduced platelets
Leukocyte reduced red blood cells
Leukocyte reduced blood component
collected by apheresis
Blood component subject to leukocyte reduction recommendations.; Example provided for leukocyte-reduced plasma components.
Eligible for pathogen reduction technology
Stakeholders
4Entities that collect blood and blood components and are the primary audience for this guidance.
GLP Regulations also require the use of a Quality Assurance Unit (QAU)
Entity responsible for releasing units after investigation
Appropriate person to terminate quarantine for a manufacturer; authorized to release product from quarantine
Regulatory Context
Attributes
9A physiological property that can contribute to analytical error in glucose monitoring.; High altitude can result in changes to hematocrit.
Intrinsic characteristic affecting the growth of L. monocytogenes; intrinsic characteristic used as a process control; parameter to monitor for control; Process control parameters such as pH; Used to define listeristatic formulations
Quality control parameter for platelets requiring the 95%/95% standard.
The count of platelets in a product, which must meet the 95%/75% standard.
Determined during the planning of a research study
Number of components manufactured during a given QC period.; Total number of products manufactured in a given QC period at a given site.
If a product does not have a proprietary name, the statement should refer only to its proper name.
Determined by analyzing process variability and data conformance
Method of reporting accuracy
Related CFR Sections (15)
- 21CFR606.20§ 606.20 Personnel.
(a) [Reserved]Read full regulation →
- 21CFR640.24§ 640.24 Processing.
(a) Separation of plasma and platelets and resuspension of the platelets must be in a closed system. Platelets must not be pooled during processing unless the platelets are pooled as specified in the directions for use for the blood collecting, processing, and storage system approved for such use byRead full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR610.60§ 610.60 Container label.
(a) Full label. The following items shall appear on the label affixed to each container of a product capable of bearing a full label:Read full regulation →
- 21CFR606.121§ 606.121 Container label.
(a) The container label requirements are designed to facilitate the use of a uniform container label for blood and blood components intended for use in transfusion or further manufacture by all blood establishments.Read full regulation →
- 21CFR606.122§ 606.122 Circular of information.
A circular of information must be available for distribution if the product is intended for transfusion. The circular of information must provide adequate directions for use, including the following information:Read full regulation →
- 21CFR606.120§ 606.120 Labeling, general requirements.
(a) Labeling operations shall be separated physically or spatially from other operations in a manner adequate to prevent mixups.Read full regulation →
- 21CFR606.100§ 606.100 Standard operating procedures.
(a) In all instances, except clinical investigations, standard operating procedures shall comply with published additional standards in part 640 of this chapter for the products being processed; except that, references in part 640 relating to licenses, licensed establishments and submission of materRead full regulation →
- 21CFR211.100§ 211.100 Written procedures; deviations.
(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, inRead full regulation →
- 21CFR606.60§ 606.60 Equipment.
(a) Equipment used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be maintained in a clean and orderly manner and located so as to facilitate cleaning and maintenance. The equipment shall be observed, standardized and calibrated on Read full regulation →
- 21CFR211.192§ 211.192 Production record review.
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (inRead full regulation →
- 21CFR211.22§ 211.22 Responsibilities of quality control unit.
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no eRead full regulation →
- 21CFR606.140§ 606.140 Laboratory controls.
Laboratory control procedures shall include:Read full regulation →
- 21CFR211.160§ 211.160 General requirements.
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted Read full regulation →
- 21CFR606.65§ 606.65 Supplies and reagents.
All supplies and reagents used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be stored in a safe, sanitary and orderly manner.Read full regulation →
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Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
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Medinatura New Mexico, Inc.
- 2025-12-16
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Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
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- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
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CDL Services, Inc. DBA Technichem
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See Also (8)
- Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001: Guidance for Industry (Status: Final)
- Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff (Status: Final)
- Use of Sterile Connecting Devices in Blood Bank Practices: Guidance for Industry (Status: Final)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)
- Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final Guidance (Status: Final)
- Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)