Scope & Applicability
Product Classes
6Blood component subject to the recommendations in this guidance
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Blood component intended for further manufacture
Guidance applies to recovered plasma intended for further manufacturing.
Not within the scope of this guidance
undergo intentional viral clearance procedures
Stakeholders
4Entities responsible for manufacture and labeling of CSP; Must follow instructions for use provided by the device manufacturer; Blood establishments that manufacture licensed blood components
Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
Entities to which this guidance does not strictly apply but may consider implementation.
Licensed establishments implementing these recommendations must report this change to FDA
Regulatory Context
Attributes
4time and temperature needed to significantly minimize Salmonella
Duration for which media fill containers are held, specified as no less than 14 days.
Required label for quarantined products used in research
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
Related CFR Sections (5)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR606.171§ 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.
(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 arrRead full regulation →
- 21CFR600.14§ 600.14 Reporting of biological product deviations by licensed manufacturers.
(a) Who must report under this section?Read full regulation →
- 21CFR606.170§ 606.170 Adverse reaction file.
(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 aRead full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
See Also (8)
- Validation of Procedures for Processing of Human Tissues Intended for Transplantation: Guidance for Industry (Status: Final)
- Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients: Guidance for Industry (Status: Final)
- IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Guidance for Industry (Status: Final)
- Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry (Status: Final)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization (Status: Final)
- Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry (Status: Final)
- Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (Status: Final)