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History of Quality Control Guidelines in the Pharma Market
Wednesday, March 5, 2025

History of Quality Control Guidelines in the Pharma Market

Drug quality is the foremost priority for the pharmaceutical industry. High-quality drug products are free from contamination and consistently deliver reliable clinical performance. The identification of a drug's quality attributes and the documentation surrounding them have been subjects of discussion for a long time. Pharmacopoeia was initially a reference work for pharmaceutical drug specifications, and it has been in existence for a long time in one form or the other.

Several early pharmacopeial books were written by Persian and Arab physicians e.g. The Canon of Medicine of Avicenna in 1025 AD and works by Ibn Zuhr (Avenzoar) in the 12th century (and printed in 1491), and Ibn Baytar in the 14th century. The earliest work presenting medical knowledge and herbal remedies may date back more than 3000 years to ancient Egypt, it was De Materia Medica, which appeared in the 1st century CE in Greece and Rome that perhaps represents the first example of a “pharmacopoeia”. The earliest known officially sponsored pharmacopoeia was compiled in 659 AD by a team of 23 pharmaceutical scientists led by Su Jing during the Tang dynasty (618-907 AD) and was called the Xinxiu Benaco. Over the years several regions/cities came up with their own pharmacopoeias which were localized.

Beginning in the 16th century, several pharmacopoeias containing medical prescriptions were prepared for apothecaries and physicians in important cities of Europe, including Nuremburg, London, Edinburgh, and Dublin. In the 19th century there was an emerging focus on efforts to standardize and harmonize the content in the pharmacopoeias. In 1820, the United States Pharmacopeia (USP) was established and in 1858 British Pharmacopoeia (BP) were created. The main aim was to bring consistency to drug standards for the benefit of pharmacy and medical practitioners and their patients. Other countries and regions also published pharmacopoeias. Currently, there are as many as 40 pharmacopoeias published around the world, with as many as 60 active pharmacopoeia commissions who carry out the work of developing and maintaining these pharmacopoeias. A pharmacopoeia can be defined as a legally binding collection of standards and quality specifications for medicines used in a country or region. Within the pharmacopoeia, a quality specification is a set of appropriate tests that will confirm the identity and purity of the product, ascertain the strength (or amount) of the active substance and, when needed, the performance characteristics. Reference substances are used in testing to help ensure the quality, such as identity, strength and purity, of medicines.

The ultimate goal of the pharmacopeias is to provide quality medicines worldwide. With this intension several regions collaborated and created their united Pharmacopeia, e.g. European Pharmacopoeia (European Directorate for the Quality of Medicines and HealthCare (EDQM), MERCOSUR pharmacopoeia is being developed to provide harmonized compendial standards for four Southern Common Market (South American) countries: Brazil, Argentina, Paraguay, and Uruguay. These regulatory authorities provide the primary standards.

Axios Research Inc is dedicated to enhancing global access to high-quality medicines by supplying top-tier reference standards to the pharmaceutical market. Our products are meticulously synthesized or isolated and undergo rigorous testing to ensure unambiguous confirmation of their structure and potency.

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