Qualification of Autosampler Dissolution Test Apparatus Type I & Type II

Abstract

Historically, the dissolution testing has been used primarily as a quality control
(QC) test for solid oral drug products performance. Dissolution testing is a basic
technique used as a qualitative test to provide the measurement of the
bioavailability of a drug as well as to demonstrate bioequivalence from batch-tobatch. The bioavailability and bioequivalence data obtained as a result of
dissolution testing can be used in the development of a new formulation and
product development processes toward product optimization, as well as to
ensure continuing product quality and performance of the manufacturing
process. In addition, dissolution is a requirement for regulatory approval for
product marketing and is a vital component of the overall quality control
program. Dissolution testing is conducted using a dissolution apparatus that
conforms to the specifications outlined in the United States Pharmacopeia. In
order to have a high degree of assurance that the dissolution apparatus is
consistent and accurate in its performance, validation is required.
Validation is defined as documented evidence that provides a high degree of assurance that a specific instrument
performs consistently according to manufacturer’s specifications, user requirements meeting Good manufacturing
practices (GMP) and Good laboratory practices (GLP). Validation is achieved by performing a series of validation
activities; for a newly installed dissolution apparatus, validation is obtained through installation qualification (IQ),
operational qualification (OQ) and performance qualification (PQ) through respective stages protocols. During
different stages of qualification, it is ensured that dissolution tester was effectively installed, operated as per user
manual & performed according to given programmed operation as per feeding instructions. During performance
qualification the calibration results of installed dissolution tester were obtained within limit. Various physical
parameters were tested like Spirit level test, Rotation per minute test, Temperature of water bath & each jar, Timer,
Wobbling test & in Chemical test performance verification test with Prednisone tablet.