21 C.F.R. Subpart I—Records and Reports
Title 21 - Food and Drugs
(a)(1) Records shall be maintained concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced. All records shall be legible and indelible, and shall identify the person performing the work, include dates of the various entries, show test results as well as the interpretation of the results, show the expiration date assigned to specific products, and be as detailed as necessary to provide a complete history of the work performed. (2) Appropriate records shall be available from which to determine lot numbers of supplies and reagents used for specific lots or units of the final product. (b) Records shall be maintained that include, but are not limited to, the following when applicable: (1) Donor records: (i) Donor selection, including medical interview and examination and where applicable, informed consent. (ii) Permanent and temporary deferrals for health reasons including reason(s) for deferral. (iii) Donor adverse reaction complaints and reports, including results of all investigations and followup. (iv) Therapeutic bleedings, including signed requests from attending physicians, the donor's disease and disposition of units. (v) Immunization, including informed consent, identification of the antigen, dosage and route of administration. (vi) Blood collection, including identification of the phlebotomist. (vii) Records to relate the donor with the unit number of each previous donation from that donor. (viii) Records of quarantine, notification, testing, and disposition performed pursuant to §§610.46 and 610.47 of this chapter. (ix) Records of notification of donors deferred or determined not to be suitable for donation, including appropriate followup if the initial attempt at notification fails, performed under §630.6 of this chapter. (x) The donor's address provided at the time of donation where the donor may be contacted within 8 weeks after donation. (xi) Records of notification of the referring physician of a deferred autologous donor, including appropriate followup if the initial notification attempt fails, performed under §630.6 of this chapter. (2) Processing records: (i) Blood processing, including results and interpretation of all tests and retests. (ii) Component preparation, including all relevant dates and times. (iii) Separation and pooling of recovered plasma. (iv) Centrifugation and pooling of source plasma. (v) Labeling, including initials of the person(s) performing the procedure. (3) Storage and distribution records: (i) Distribution and disposition, as appropriate, of blood and blood products. (ii) Visual inspection of whole blood and red blood cells during storage and immediately before distribution. (iii) Storage temperature, including initialed temperature recorder charts. (iv) Reissue, including records of proper temperature maintenance. (v) Emergency release of blood, including signature of requesting physician obtained before or after release. (4) Compatibility test records: (i) Results of all compatibility tests, including crossmatching, testing of patient samples, antibody screening and identification. (ii) Results of confirmatory testing. (5) Quality control records: (i) Calibration and standardization of equipment. (ii) Performance checks of equipment and reagents. (iii) Periodic check on sterile technique. (iv) Periodic tests of capacity of shipping containers to maintain proper temperature in transit. (v) Proficiency test results. (6) Transfusion reaction reports and complaints, including records of investigations and followup. (7) General records: (i) Sterilization of supplies and reagents prepared within the facility, including date, time interval, temperature and mode. (ii) Responsible personnel. (iii) Biological product deviations. (iv) Maintenance records for equipment and general physical plant. (v) Supplies and reagents, including name of manufacturer or supplier, lot numbers, expiration date and date of receipt. (vi) Disposition of rejected supplies and reagents used in the collection, processing and compatibility testing of blood and blood components. (c) A donor number shall be assigned to each accepted donor, which relates the unit of blood collected to that donor, to his medical record, to any component or blood product from that donor's unit of blood, and to all records describing the history and ultimate disposition of these products. (d) Records shall be retained for such interval beyond the expiration date for the blood or blood component as necessary to facilitate the reporting of any unfavorable clinical reactions. The retention period shall be no less than 5 years after the records of processing have been completed or 6 months after the latest expiration date for the individual product, whichever is a later date. When there is no expiration date, records shall be retained indefinitely. (e) A record shall be available from which unsuitable donors may be identified so that products from such individuals will not be distributed. [40 FR 53532, Nov. 18, 1975, as amended at 61 FR 47422, Sept. 9, 1996; 64 FR 45371, Aug. 19, 1999; 65 FR 66635, Nov. 7, 2000; 66 FR 31176, June 11, 2001] (a) Distribution and receipt procedures shall include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall, if necessary. (b) Distribution records shall contain information to readily facilitate the identification of the name and address of the consignee, the date and quantity delivered, the lot number of the unit(s), the date of expiration or the date of collection, whichever is applicable, or for crossmatched blood and blood components, the name of the recipient. (c) Receipt records shall contain the name and address of the collecting facility, date received, donor or lot number assigned by the collecting facility and the date of expiration or the date of collection, whichever is applicable. (a) Records shall be maintained of any reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of blood collection or transfusion. A thorough investigation of each reported adverse reaction shall be made. A written report of the investigation of adverse reactions, including conclusions and followup, shall be prepared and maintained as part of the record for that lot or unit of final product by the collecting or transfusing facility. When it is determined that the product was at fault in causing a transfusion reaction, copies of all such written reports shall be forwarded to and maintained by the manufacturer or collecting facility. (b) When a complication of blood collection or transfusion is confirmed to be fatal, the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, shall be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible; a written report of the investigation shall be submitted to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, within 7 days after the fatality by the collecting facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion reaction. [40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 50 FR 35471, Aug. 30, 1985; 55 FR 11014, Mar. 26, 1990; 64 FR 45371, Aug. 19, 1999; 67 FR 9586, Mar. 4, 2002] (a) Who must report under this section? You, a licensed manufacturer of blood and blood components, including Source Plasma; an unlicensed registered blood establishment; or a transfusion service who had control over the product when the deviation occurred, must report under this section. If you arrange for another person to perform a manufacturing, holding, or distribution step, while the product is in your control, that step is performed under your control. You must establish, maintain, and follow a procedure for receiving information from that person on all deviations, complaints, and adverse events concerning the affected product. (b) What do I report under this section? You must report any event, and information relevant to the event, associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of both licensed and unlicensed blood or blood components, including Source Plasma, if that event meets all the following criteria: (1) Either: (i) Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product; or (ii) Represents an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and (2) Occurs in your facility or another facility under contract with you; and (3) Involves distributed blood or blood components. (c) When do I report under this section? You should report a biological product deviation as soon as possible but you must report at a date not to exceed 45-calendar days from the date you, your agent, or another person who performs a manufacturing, holding, or distribution step under your control, acquire information reasonably suggesting that a reportable event has occurred. (d) How do I report under this section? You must report on Form FDA–3486. (e) Where do I report under this section? You must send the completed Form FDA–3486 to the Director, Office of Compliance and Biologics Quality (HFM–600) (see mailing addresses in §600.2 of this chapter) by either a paper or electronic filing: (1) If you make a paper filing, you should identify on the envelope that a BPDR (biological product deviation report) is enclosed; or (2) If you make an electronic filing, you may submit the completed Form FDA–3486 electronically through CBER's website at www.fda.gov/cber. (f) How does this regulation affect other FDA regulations? This part supplements and does not supersede other provisions of the regulations in this chapter. All biological product deviations, whether or not they are required to be reported under this section, should be investigated in accordance with the applicable provisions of parts 211, 606, and 820 of this chapter. [65 FR 66635, Nov. 7, 2000, as amended at 70 FR 14984, Mar. 24, 2005]
Title 21: Food and Drugs
PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
Subpart I—Records and Reports
§ 606.160 Records.
§ 606.165 Distribution and receipt; procedures and records.
§ 606.170 Adverse reaction file.
§ 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.
