A Study on Quality Control Tests for Dosage Forms and their Effect on Physical, Chemical and Biological Specifications: A Review

Abstract

The main criteria for quality of any drug in solid dosage forms (tablets and capsules) and liquid dosage forms(syrup) are its safety, potency, efficacy, stability, patient acceptability and regulatory compliance. 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, capsules and suppositories are performed with respect to specification of the pharmacopoeias in order to check that the quality parameters are within acceptance limits or not. The aim of this study is to provide review of physical and chemical quality control tests for solid dosage forms, liquids (syrups) in-process and finished products quality control tests for pharmaceutical products according to pharmacopoeias. The tests described are essential for ensuring the safety and efficacy of these products.