NDA or ANDA
New Drug Application – Required prior to offering a new drug to market Abbreviated New Drug Application – Used for the submission of a generic drug application to the FDA
Archives: Dictionary
OOS
Out-of-Specification – An event that is not acceptable according to the manufacturing document or other acceptance criteria.
Peristaltic Pump
This type of pump transfers fluids through tubing with the use of rollers or lobes to compress the tubing and force the fluid forward.
pH
Has a scale of zero to 14. pH of < 7 is an acid 7 is neutral pH > 7 is a base.
pH meter
An electronic instrument used to measure the pH (acidity or alkalinity) of a substance.
Pipette
Lab equipment used to measure a volume of liquid between 100 milli-litres and 1 micro-liter. Alternative names: pipete, pipettor
PLC
Programmable Logic Controller – manages computer controlled biotech processes
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.
QSR
Quality System (QS) regulations are established by the FDA under CFR Ttile 21 part 820.
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”.