The last century has seen a steady improvement in the quality of life for people across the world. While several factors have contributed to this development, advances in medical technology have played a significant role. The discovery of new drugs, development of vaccines and therapeutics have transformed the healthcare industry, making previously fatal ailments curable and in some cases, preventable;. Having said that, novel infections such as SARS-CoV-2 continue to present new challenges and opportunities. This makes maintaining the quality of pharmaceutical products paramount in order to ensure safety of the patient. A pharmaceutical product that does not meet the required standards can pose a serious threat to public health and safety. However, what does pharmaceutical quality mean?
Before we delve into the meaning of pharmaceutical quality, it may be beneficial to explore the meaning of the word ‘quality’ itself. Herein lies the first hurdle, as there is no consensus on the definition of quality for any product or service. This, however, has not deterred the presentation of unique perspectives. J.M. Juran defines quality as ‘fitness for purpose’ while Phillips Corby defines it as ‘conformance to requirement’. Some theorists argue that quality means different things when considered from the perspectives of a manufacturer and a consumer. To complicate things further, some suggest that quality could mean different things to different consumers based on their specific needs.
The quality of a pharmaceutical product is determined by the quality of the raw materials, equipment, and the technical knowledge required to process, package, and distribute the product. Unlike most other goods, pharmaceutical products are dynamic/versatile in nature. The weight, colour, consistency, and even chemical composition can change between production and consumption. The quality of a pharmaceutical product is grounded in the efficacy and safety of the Active Pharmaceutical Ingredients (API), formulation, manufacturing, and supply chain functions. The potential effects of a sub-par quality product being consumed could be highly damaging to the health of a patient and may have long-term implications on public trust in pharmaceuticals.
In the case of the USFDA, the understanding of drug quality is linked to the consistent delivery of the label performance and lack of contamination. This definition is operationalized by a predefined set of quality attributes (e.g., specifications, limits) and through the Current Good Manufacturing Practices (CGMP) regulations.[ Woodcock, Janet. (2004). The concept of pharmaceutical quality. American Pharmaceutical Review. 7. 10-15. ] The Federal Food, Drug, and Cosmetic Act (the Act) states that drugs that do not adhere to the CGMP regulations are deemed ‘adulterated’. A different perspective suggests that pharmaceutical quality should be defined as ‘fitness of use’. The ‘fitness of use’ of a product can be defined by whether it meets its designed attributes and meets the standards set out by a regulatory authority.
The concept of pharmaceutical quality is dynamic and ever evolving. Is pharmaceutical quality –
Meeting predetermined specifications or quality attributes?
Delivering the same results as clinical
Manufacturing as per CGMPs to eliminate harmful contamination or impurities?
Delivering drugs safely, in a timely manner, and at an affordable price?The answer is likely to be a combination of all the above.
Quality forms the basis of ensuring the availability of safe and effective treatments and therapies to patients. There have been several questions raised regarding the overall quality of drugs available in the US, particularly in relation to generic drugs and internationally manufactured drugs. Surveys have indicated that a majority of healthcare practitioners are uncertain of the quality of drugs manufactured outside the US.[ Duke Margolis Center for Health Policy. Understanding how the public perceives and values pharmaceutical quality. https://www.youtube.com/watch?v=dYrVIxVN0ZA] A recent study set out to assess whether there are substantive differences in the major quality attributes of difficult-to-make pharmaceutical products manufactured throughout the world and marketed in the US. The study found that all the drug product samples met the US market standards for the major quality attributes of dosage unit uniformity and dissolution. The findings from the study indicated that drugs were of standard quality irrespective of the country of manufacturing or manufacturing company. This also demonstrated that generic drugs were of standard quality3.
1Woodcock, Janet. (2004). The concept of pharmaceutical quality. American Pharmaceutical Review. 7. 10-15.
2Duke Margolis Center for Health Policy. Understanding how the public perceives and values pharmaceutical quality. https://www.youtube.com/watch?v=dYrVIxVN0ZA
3Fisher AC, Viehmann A, Ashtiani M, et al. Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US. JAMA Network Open. 2020;3(8):e2013920. doi:10.1001/jamanetworkopen.2020.13920
Under this series on ‘Quality’, we will discuss various factors that can influence the quality of pharmaceutical products. Next blog post will be published in the month of November 2020. Stay Tuned!
-Mr. Shirish Belapure, Senior Technical Advisor, IPA
Tags:
Vaccines, USFDA, SARS-coV-2, Active Pharmaceutical Ingredients (API), pharmaceutical, CGMP, MHRA, API, CDSCO, Quality
