Let us delve into 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 and 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.
Now, let's explore some common terms between QbD and 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 (10mg, 20mg), Shelf life (24month, 36month), Pharmacokinetics (Tmax, Cmax, AUC)
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, resolution, and relative retention times.
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.
What are your thoughts on QbD and AQbD? Share your insights.