Let's discuss on two commonly used terms in the pharmaceutical industry: QbD (Quality by Design) and AQbD (Analytical Quality by Design). These terms are crucial for ensuring product quality & process control.
QbD
Dr. Joseph M. Juran developed the QbD concept in the 1990s. QbD was first proposed by the ICH in the Q8 guidelines. It emphasizes a systematic approach to development that starts with predefined objectives. It emphasizes product and process understanding, sound science, and quality risk management. Predefined objectives are pivotal in product development.
AQbD
Parallel to QbD, ICH Q14 introduces AQbD, which applies the same principles to analytical method development.
Let's explore some common differences between QbD & AQbD
𝟏. 𝐐𝐓𝐏𝐏 𝐯𝐬. 𝐀𝐓𝐏 (Quality Target Product Profile vs. Analytical Target Profile):
QTPP: A prospective summary of a drug product's quality characteristics, ensuring the desired quality, safety, and efficacy. The examples are Dosage forms (tablet, IV), Dosage design (IR, MR), Dosage strength (10, 20mg), Shelf life (24, 36month), Pharmacokinetics (Tmax, Cmax)
ATP: A prospective summary of the performance characteristics, describing the intended purpose and anticipated performance criteria of analytical measurement. It emphasizes performance characteristics like specificity, precision, accuracy, and linearity.
𝟐. 𝐂𝐐𝐀 𝐯𝐬. 𝐂𝐀𝐀 (Critical Quality Attribute vs. Critical Analytical Attribute):
CQA: A property or characteristic that should be within an appropriate range to ensure the desired product quality or QTPP. Examples include identification, assay, related substances, and dissolution.
CAA: Analytical method attributes that should be within an appropriate limit to achieve the desired ATP. Examples encompass peak area, retention time, plate count, tailing factor.
𝟑. 𝐂𝐏𝐏 𝐯𝐬. 𝐂𝐌𝐏 (Critical Process Parameters vs. Critical Method Parameters):
CPP: Process parameters whose variability impacts CQAs and must be monitored or controlled for desired quality. Examples include granulation time and blending time.
CMP: Independent analytical variables influencing CAA, such as mobile phase composition, pH, buffer strength, flow rate, or injection volume.
𝟒. 𝐂𝐌𝐀 𝐯𝐬. 𝐂𝐌𝐌𝐀 (Critical Material Attributes vs. Critical Method Material Attributes):
CMA: Material attributes that affect CQAs, necessitating monitoring or control for drug product quality. Examples include particle size, moisture content, and purity.
CMMA: Attributes of materials used in analysis, influencing CAA. This includes the quality of reagents, column stationary phase, or types of glassware used.
Understanding these terms is essential for achieving quality, safety, and efficacy in pharmaceutical product and analytical method development.
Related:
Resource Person: Bhaskar Napte
