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Discovery & Development Analytical Science, Contract Development Services, Dosage Forms, Supply Chain

Hidden Analytical Advantages

How do you choose which properties to measure when it comes to characterizing APIs, excipients, or even the formulation? The identification of critical quality attributes (CQAs) and critical material attributes (CMAs) is an integral component of Quality by Design (QbD) but decisions around how best to measure them are not always easily made in-house. QbD places emphasis on process and product understanding, and is intended to reduce risk. Though potentially demanding, it facilitates a more flexible regulatory approach – an important consideration when putting together the robust submission package required. The knowledge accrued is also helpful for ensuring secure optimization of the supply chain (1). And beyond CQAs and CMAs may lie many additional variables – powder flowability, porosity and specific surface area, for example, depending on the pharmaceutical product type, can affect development and manufacturing and are, therefore, valuable to measure. 

The challenges are significant, so many companies choose to outsource their analytical testing. In fact, in 2018, the global pharmaceutical analytical testing outsourcing market was valued at $5.59 billion and is set to grow by 8.1 percent over the next seven years (2). The accrual of savings holds value for many as the need to invest in and use new instrumentation and train staff falls away. Choosing a good contract laboratory or analytical service gives you access to a broad range of equipment as well as in-depth expertise.

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About the Author

Greg Thiele

General Manager at Particle Testing Authority, a Micromeritics company.

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