Analytical Quality by Design and Quality Control of drugs: from Quality Target Product Profile to the Analytical Target Profile

Quality Control (QC) plays a pivotal role in the pharmaceutical and biopharmaceutical development, as it is essential for assessing product's quality, safety and efficacy. It involves a series of analytical procedures designed and validated to inspect and monitor the product’s quality attributes. The Quality Target Product Profile (QTPP) is a concept described in the International Council for Harmonisation (ICH) Q8, which includes all the critical quality attributes of the product. One or more analytical procedures (AP) can be established to address a particular (or various) product’s quality attribute(s), being the analytical performance requirements established based on the QTTP. The Analytical Target Profile (ATP) is the element within the Analytical Procedure Life Cycle which describes the AP intended purpose and performance requirements and is described in ICH Q14 draft guideline and USP <1220>. The ATP is what links the APLC to the product’s life cycle. In the context of AP development, ICH Q14 outlines scientific principles for developing, managing, and submitting APs in Marketing Authorization Application (MAA), while ICH Q2(R2) focuses on analytical procedure validation. Additionally, USP Chapter <1220> provides a framework that incorporates a holistic view of various aspects of the AP lifecycle to ensure procedure fitness for use, which is driven by Analytical Quality by Design (AQbD) principles. Examples of application of AQbD principles for QC of small molecules and biological drugs will be given.