FAT
Factory Acceptance Test – Testing done at the manufacturers factory to ensure product meets their release criteria.
Category: Methods
Common methods and job role description definitions.
GDP
Good Document Practice – Good document practices used whenever GMP operation data is recorded on controlled documents.
GxP
Good ______ Practice or Procedure – GMP, GLP, GCP, GDP
HPLC
High-pressure liquid chromatography An instrument used to separate a mixture of compounds using chromatography in order to identify and calculate percent quantity.
Ion chromatographs
Ion chromatography is also referred to as affinity chromatography.
Purification
Typical protein purification uses various chromatography and UF/DF techniques. Pictured is an AKTA Pilot which can handle flow rates in the 100-300mL/min range. The various lines would be attached to a column and inserted into containers of buffers and other solutions used to wash, bind, strip and or elute the desired substance.
SOP
Standard Operating Procedure The International Conference on Harmonization (ICH) defines a SOP as “detailed, written instructions to achieve uniformity of the performance of a specific function”.
Titration
The adjusting of a solution’s pHÂ through the addition of an acid or a base. Performed by automatic titrators or manually with the use of a pH meter.
Ultrafiltration (UF) / Diafiltration (DF)
A technique that uses special filters to sort and/or wash solutions on a molecular level. May also be referred to as concentration and dialysis. Pictured is a Pellicon UF/DF system with tubing running through a peristaltic pump. The lines are inserted into an Erlenmeyer flask containing the UF/DF membrane storage solution.
Validation
Confirming that the outcome is repeatable and is what as expected.