The Department confirms that a medicine is compliant with its stated label claim using the industry recognized monographs and standards of the British Pharmacopoeia (BP) and United States Pharmacopeia and National Formulary (USP). The Pharmacopoeias specify the required tests and acceptable limits for individual medicinal formulations. Manufacturer’s test methods and reference standards are employed when the product makes no stated claim to either standard.
Medicines quality control evaluates the product parameters of potency, dose uniformity, specificity, efficacy, stability, identity and purity. Similarly, efficacy and safety studies of medicines and their usefulness in therapeutic and medical treatment are dependent upon the amount of active pharmaceutical ingredient present in the product. These limits are established on both scientific data and the relationship between an ineffective dose and a therapeutically useful dose in comparison to a therapeutically useful dose and a toxic dose.
The Department employs chemical methods of analysis including simple physico-chemical analysis, titrimetric analysis and chromatography. Technological innovation allowed expansion of the type of medicines that can be analysed through reduction in analytical time and improvement in detection limits with more complex techniques such as Spectrometry (UV/Vis, Infra-red) and the most commonly used method in medicines analysis, High-Pressure Liquid Chromatography (HPLC).