The Role of Pharmacopoeia in Quality Control of Drug Substances and Pharmaceutical Products

This essay discusses the importance and roles of pharmacopoeia in quality control of drug substances and pharmaceutical products. It explores how pharmacopoeia protects patients from counterfeit and substandard drugs, provides quality specifications, defines legally binding quality standards, revises existing specifications, and more.

The role of Pharmacopoeia in quality control of Drug Substances and Pharmaceutical Products
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Introduction
A pharmacopoeia is a book with a list of recognized drugs, their effects and directions on their
use. It can either be published by the government or the pharmaceutical society. Previously,
pharmacopoeia used to only collect medical receipts just to ensure that pharmacists dispense
medicines accurately. However, this have changed and the pharmacopoeia has diverse roles1.
The major role involves regulating active pharmaceutical ingredients and drug products which
are used by pharmaceutical companies. There is the need to optimize quality standards of drugs
so as to protect the general public against consumption of counterfeit and substandard drugs
globally. Within the framework of this essay, there will be a discussion on the importance or the
roles of the pharmacopoeia.
Discussion
The pharmacopoeia protects patients from adultered and counterfeit medicine. A counterfeit
product can be defined as any product made and sold under a major brand without the brands
authorization. An adultered product on the other hand is defined as any product that is
substandard2. According to recent surveys, increased globalization is likely to increase
counterfeit and adultered products and the pharmaceutical industry not exempted. Counterfeit
and adultered medicines has in the risen past be on the rise. Mackey, Aung and Liang in their
article “Illicit Internet availability of drugs subject to recall and patient safety consequences,”
state how illicit online pharmacies are providing counterfeit and substandard drugs to the public.
Kumar and Baldi on the other hand highlight how counterfeit drugs are a global concern. The
study states that close to 35% of the drugs in circulation are counterfeit. The study notes that
such drugs are a public health threat to the people3. According to the World Health Organization,
counterfeit drugs contributed to 5% mortality rates in 2016. Due to these negative consequences,

the pharmacopoeia is vigilant enough to ensure that such drugs do not exist. It usually achieves
this by adjusting its standards of manufacturing drugs and revising monographs whenever there
is need.
The pharmacopoeia provide quality specifications for drugs and overall requirements of the
different dosage forms. The pharmacopeia is responsible for conducting clinical trials to
determine the best dose to be used by each particular age group or gender4. Since several studies
indicate that an overdose or under dose is likely to harm the body, this is a good move by the
pharmacopoeia to ensure that people get the right quantity of drugs.
It defines legally binding quality standards to be used in case of disputes. For any disputes to be
resolved, there should be certain standards that should act as the reference point. The
pharmacopeia ensures that disputes pertaining the use of drugs are settled by coming up with
certain standards5. Recently, certain changes have been adopted by ICH concerning quality risk
management and quality systems that include ICH guidelines Q8, Q9 and Q10 have been
established and the pharmacopoeia ensures strict adherence towards the same.
Pharmacopoeia is responsible for revising existing specifications and requirements. In case there
are concerns or complains from the public about certain drugs or standards, it is the role of the
pharmacopeia to conduct studies and revise the existing standards so that they are in line with the
needs of the public6. Pharmacopoeia conducts regular analysis of drugs in the market. Since
some pharmacists are known to alter the actual composition of drugs, the Pharmacopoeia
conducts regular analysis of the drugs on the shelves just to ensure that they are within the
recommended standards. Furthermore, it regulates the supply of certain drugs to doctors for
prescription. This is because certain medicines are very addictive and can be used for the wrong
purpose by patients. Some of these drugs are the opioids and were once over used by patients in

the USA due to their laxative effects7. Finally, the pharmacopoeia inspects and issue license to
pharmaceutical companies just to regulate the whole process of drug production.
Conclusion
With increased globalization, the pharmaceutical industry is at risk of counterfeit and adultered
drugs through illicit online pharmacies. The pharmacopoeia plays a critical role in preventing
such cases whereby the public is subjected to such substandard drugs. However, it is important
that other stakeholders realize that achieving uniform standards of drugs cannot be achieved by
Pharmacopoeia alone. Other stakeholders should step in the fight against substandard and
counterfeit drugs for the benefits of the general population.

References
1. Anderson, S. (2016). The British Pharmacopoeia, 1864 to 2014: Medicines, International
Standards and the State by Anthony C. Cartwright. Bulletin of the History of Medicine,
90(2), 340-342. doi:10.1353/bhm.2016.0046
2. Mackey, T. K., Aung, P., & Liang, B. A. (2015). Illicit Internet availability of drugs
subject to recall and patient safety consequences. International Journal of Clinical
Pharmacy, 37(6), 1076-1085. doi:10.1007/s11096-015-0154-8
3. Rose, U. (2016). Participation of industry experts in the elaboration of monographs and
chapters of the European Pharmacopoeia. European Journal of Pharmaceutical Sciences,
93, 504-506. doi:10.1016/j.ejps.2016.01.030
4. Uddin, M., Hossain, M., Mamun, A., Zaman, S., Asaduzzaman, M., & Rashid, M.
(2016). Pharmacopoeial Standards and Specifications for Pharmaceutical Aerosols: In-
Process and Finished Products Quality Control Tests. Advances in Research, 6(3), 1-12.
doi:10.9734/air/2016/22442
5. Uddin, M., Mamun, A., Rashid, M., & Asaduzzaman, M. (2016). In-process and Finished
Products Quality Control Tests for Pharmaceutical Capsules According to
Pharmacopoeias. British Journal of Pharmaceutical Research, 9(2), 1-9.
doi:10.9734/bjpr/2016/22044
6. Wang, M., & Franz, G. (2015). The role of the European Pharmacopoeia (Ph Eur) in
Quality Control of Traditional Chinese Herbal Medicine in European Member States.
World Journal of Traditional Chinese Medicine, 1(1), 5-15. doi:10.15806/j.issn.2311-
8571.2014.0021

7. Wierer, M. (2012). European Pharmacopoeia Monographs on Herbal Drugs used in
Traditional Chinese Medicines - An Update from the European Directorate for the
Quality of Medicines. Planta Medica, 78(05). doi:10.1055/s-0032-1307505