Pharmaceutical Quality Assurance and the World Health Organization

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The World Health Organization (WHO) is one of the largest and most important specialized agencies of the United Nations (UN). The WHO was established in recognition of the fact that global cooperation is often needed to combat cross-border diseases and other international health challenges. With close to every country in the world being a member, the WHO plays a pivotal role in global public health, including in improving regulations and standards for pharmaceuticals.

If you’re considering enrolling in pharmaceutical quality assurance courses, you’ll learn about regulatory standards around the world. The WHO is often a major player in helping develop those standards, such as in the following ways.

The WHO Model List of Essential Medicines Has Had a Significant Impact on Health

A significant part of the WHO’s role stems from its Model List of Essential Medicines (EML). In a nutshell, the EML is a list of medicines that everyone in the world should have affordable and safe access to. The original list was created in 1977 and included 212 medications. Since then it has been updated every two years and now includes 433 medications.

The EML is important for quality assurance for two reasons. One, it is the list that national health agencies around the world use as a guide for determining their own national essential medicines lists. While Canada does not currently have an essential medicines list, clinicians are developing a peer-reviewed list of essential medicines based on the WHO EML. That list could serve as a blueprint for creating an official Canadian essential medicines list in the future.

Secondly, the WHO releases the International Pharmacopoeia, which is a book of quality specifications for pharmaceutical drugs and dosage forms and it is largely based on the EML. The International Pharmacopoeia is used by health agencies and pharmaceutical manufacturers around the world for developing pharmaceuticals to a safe and consistent standard. Because Canada does not have its own national pharmacopoeia, Canadian pharmaceutical and health professionals frequently rely on the International Pharmacopoeia, along with other pharmacopoeias printed by health agencies and organizations in Canada and around the world.

The WHO Issues Guidelines and Standards for Pharmaceutical Quality Assurance

The International Pharmacopoeia is just one example of how the WHO has a direct impact on the quality assurance measures of pharmaceuticals all over the world, but it is not the only example. The WHO also issues guidance concerning good manufacturing practices (GMP), pharmaceutical testing, laboratory prequalification, certification for quality assurance agencies, and much more. If you study pharmaceutical quality assurance courses, you will learn about GMP, global regulatory strategies, and pharmaceutical lab testing, all of which are influenced by the WHO.

The WHO helps set guidelines for quality assurance, like good manufacturing practices

While member states are not obliged to adopt WHO guidelines, in many cases they do anyway since having a global standard for pharmaceutical quality assurance is often in the interests of every WHO member state. Obviously not all national health agencies have the same resources for tackling quality assurance issues and in some low- and middle-income countries WHO guidelines remain an ideal rather than current practice. The ultimate goal of global quality assurance standards, however, is to ensure that everyone has access to the same high-quality medications no matter where they are in the world.

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