Author: BasyeG

FDA requires that manufacturing conditions and practices achieve purity and potency of all products. Transfusion services achieves cGMP by the following steps:
Receipt including inspection and lot number recording.
Recording lot numbers in use.
Performing appropriate QC testing prior to reagent use.
Performing acceptability inspection at each step in our processes.
Recording all communications with suppliers including recall notifications.

FDA requires all elements relevant to the collection of blood and dispensing of products must be documented. Several examples of record keeping at Transfusion services include:

Technologist/duty and date performed
Compatibility testing and results
Processing, distribution and storage
Adverse reactions

Transfusion Services maintains a process for review and approval of new and revised documents.
A master list of all documents is archived at Transfusion Services.
Processes are utilized to ensure that only current and valid documents are available at essential locations.
Obsolete documents are identified and archived.

Working as a team to ensure the final product is safe, pure, potent and effective.

Current Good Manufacturing Processes require that all methodology and procedures are validated according to reliable manufacturing processes. Here are some examples of traceable standards in Transfusion Service:
The TSL thermometers are calibrated against the NIST thermometer annually.
Centrifuges are calibrated with a tachometer semi-annually.
The TANGO automated Blood Bank Analyzer used by HMC Transfusion Service has been validated by running samples on the instrument and comparing the results of those same samples with the results obtained by another method such as tube testing method.