Quality of Pharmaceutical Products
The suitability of drugs for their intended use is determined by:
- Their efficiency weighed against safety, according to label claim, or as promoted or publicized
- Their conformity to specifications regarding identity, purity and other characteristics.
The quality assurance of pharmaceutical products is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made to ensure that pharmaceutical products are of the quality required for their intended use.
The quality control of pharmaceutical products is a concept that covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that the raw materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.