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By Tom Sam

TomSamTo deliver optimal therapy to the patient, it is critical to select and develop quality medicines with a patient-centric drug product design, and to subsequently control their product and process development, their manufacturing processes, and their external supply chain. Quality metrics are seen as a tool to evaluate and optimize the manufacturing process, and an enhanced quality culture mindset is needed to sustainably deliver quality medicines throughout their life cycle.

We all know that quality matters, but to most of us, it is a rather intangible property. Quality may mean different things to different people in different circumstances. In most cases, we sense the importance of quality only when we see defects or clearly suffer from the fact that we cannot use the product properly. This also holds when the product is a medicine, since the impact of poor-quality medicines is experienced when, for instance, we encounter drug shortages and product recalls. The quality of a medicine can be defined as the degree to which the medicinal product is capable of consistently delivering its safety and clinical attributes to the patient. To obtain such a quality product, the appropriate dosage form to optimally use the therapeutic potential of the medicine should be selected, as well as quality ingredients and quality manufacturing processes.

How can one reduce the risk of developing a product that does not exhibit the required quality? It is important to start the development process by defining a target product profile summarizing the quality characteristics of a drug product that should be achieved to ensure the desired quality, taking into account its safety and efficacy. Even for a single drug, there are many combinations of drug substance form (e.g., specific salt, ester, prodrug or probiological compound), excipients, and packaging materials. The goal should be to create the optimal drug product with the highest therapeutic value for the specific patient target population that is appropriate for these patients. It is also important to ensure the drug can and will be used as intended, which could lead to modifications to prevent misuse or abuse.

In the August issue of the AAPS Newsmagazine, we discuss designing quality into drug development and manufacturing, as well as the use of quality metrics and creation of quality culture. Read Quality Metrics, Quality Culture, Quality Matters!, from the Manufacturing Science and Engineering (MSE) section, and then participate in the discussion point below.

What kind of measures would you propose to assure that only adequately developed and manufactured quality products reach patients?

Tom Sam recently retired from MSD (Merck in the USA) after a career spanning three decades working in pharmaceutical development and CMC regulatory science.