Drug Quality

In general, medicines including vaccine are products that must be registered before being launched onto the market by government sector or widely known in short as FDA (Food and Drug Administration) who sets related regulations to ensure that drugs that are launched onto the market meet quality, safety, and efficacy standard, mainly for the benefit of the patients.


The regulations covers various aspects of drug registration from drug development stage, production, and quality control of Active Pharmaceutical Ingredients (API) including packaged products to ensure that patients receive products that are of good quality and safety. Meanwhile, the World Health Organization (WHO) has published a guideline to evaluate drug quality to ensure that drug safety and efficacy meets expectation. On the other hand, all patients have a fundamental right to receive drugs that meet standard quality. In pharmaceutical industry, it is crucial to conduct drug research that meet quality in an international standard to assure that drugs they have researched, manufactured, and launched onto the market maintain the same quality everywhere in the global market by referencing the agreed international standard known as International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( ICH ).

At the same time, WHO has a role in specifying necessary features of drug quality e.g. drugs to cure AIDS, Malaria, TB and disease concerning reproduction. WHO specifies that these drugs can be purchased for countries in need through various funds.

Hence, setting an internal standard to control quality of drugs from pre-production process until drug delivery ensures that drug quality can be expected and it is very beneficial to patients. Consequently, WHO published the International Pharmacopoeia by collecting specifications for the determination of pharmaceutical substances and dosage forms including general information for drug analysis that is intended to serve as source of information for any WHO member state wishing to establish pharmaceutical requirements of related drugs.