Concepts:
- Check upon receipt
- Record disposal of unacceptable reagents
- Track use
CFR Title 21 Part 211 discusses the cGMP requirements for finished pharmaceuticals, which also apply to blood products. The portions that are directly applicable to blood products are listed.
Subpart E Section 211.809
General requirements for control of components, containers, and closures.
(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.
(b) Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination.
(c) Bagged or boxed components of drug product containers or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection.
(d) Each container or grouping of containers for components, drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).
Subpart E Section 211.829
Receipt and storage of untested components, drug product containers, and closures.
(a) Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.
(b) Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, whichever is appropriate, and released. Storage within the area shall conform to the requirements of 211.80.
Subpart E Section 211.849
Testing and approval or rejection of components, drug product containers, and closures.
...Any lot of such material that does not meet such specifications shall be rejected.
Subpart E Section 211.869
Use of approved components, drug product containers, and closures.
Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.
9. Code of Federal Regulations. Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart E "Control of Components and Drug Product Containers and Closures." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211?toc=1.
