In-process and finished products quality control tests for pharmaceutical tablets according to Pharmacopoeias

Abstract

A pharmaceutical tablet must satisfy certain standards to claim it to be a quality drug. The main criteria for quality of any drug in dosage form are its safety, potency, efficacy, stability, patient acceptability and regulatory compliance. The quality of a pharmaceutical tablet needs to be designed from the product development stage. At the product design and formulation stage the physical, chemical and biological specifications, to which the product must comply with to fulfill quality requirements, have to determine and the target for quality must be set. In-process quality control (IPQC) tests are strongly related to final products quality because checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specification are the key for good quality pharmaceutical tablets. The purposes of IPQC are to produce a perfect finished product by preventing or eliminating errors at every stage in production. After the manufacturing process is complete finished product quality control (FPQC) tests for pharmaceutical tablets are performed with respect to specification of the pharmacopoeias in order to checks that the quality parameters are within acceptance limits or not. The aim of this study is to provide in-process and finished products quality control tests for pharmaceutical tablets according to pharmacopoeias.