QbD

CPP and CQA in Different Stages of Drug Product Manufacturing

Byipharmacist July 6, 2024September 7, 2024

Critical Process Parameters (CPP), Critical Quality Attributes (CQA) & It’s Stages

1) Wet Granulation

CPP: Mixing Time, Impeller Speed, Temperature, Binder Fluid addition Rate & Time, Method of Binder addition.
CQA: Moisture Content, Blend Uniformity, Granule Size & Distribution.

2) Drying

CPP: Drying Time, Inlet air flow, Exhaust air temperature & flow.
CQA: Moisture Content, Bulk/Tapped Density, Granules Strength & Uniformity.

3) Milling

CPP: Milling Speed, Screen Size, Feeding Rate.
CQA: Bulk/Tapped Density, Flow Properties, Particle Size Distribution.

4) Mixing

CPP: Mixing Time, Mixer Type, Order of Addition.
CQA: Blend Uniformity.

5) Compression

CPP: Pre Compression Force, Main Compression, Ejection Force, Dwell Time, Hopper Design, Roller Type, Punch Penetration Depth, Auger Screw Rate.
CQA: Weight Variation, Hardness, Frability, DT, Dissolution, Assay, Content Uniformity.

6) Coating

CPP: Time, Temperature, Inlet Air Flow, Spray Pattern & Rate.
CQA: Appearance, Thickness, Hardness, % of Weight Gain.

Process Capability and Continual Improvement in QbD

Byipharmacist December 19, 2023September 9, 2024

Process capability measures the inherent variability of a stable process that is in a state of statistical control in relation to the established acceptance criteria. Calculations based on the inherent variability due to common cause of a stable process (i.e., in a state of statistical control) result in process capability (Cp and Cpk) indices….

QbD

Product Design and Understanding in QbD

Byipharmacist December 8, 2023September 9, 2024

Over the years, QbD’s focus has been on the process design, understanding, and control, as discussed in the ICHQ8 (R2) guidance. It should be emphasized that product design, understanding, and control are equally important. Product design determines whether the product is able to meet patients’ needs, which is confirmed with clinical studies. Product design…

QbD

Quality by Design (QbD) in Pharmaceutical Industry

Byipharmacist September 20, 2023September 10, 2024

QbD, or Quality by Design, is a systematic approach to pharmaceutical development and manufacturing that aims to ensure product quality by design, rather than by testing and inspection after production. But the principle of QbD can be applied to all stages of the product lifecycle, from research and development to commercial production. Key Components…

QbD

Quality by Design (QbD) and Design Space in Pharmaceutical Development

Byipharmacist August 24, 2024September 7, 2024

Formulation design is crucial to ensure that our products meet quality expectations. By applying QbD principles, we can systematically understand the relationship between critical formulation factors and their impact on Critical Quality Attributes (CQAs). Key elements to consider: 1. Quality Target Product Profile (QTPP): Defines the desired quality characteristics of the final product. 2….

QbD

Control Strategy in QbD

Byipharmacist December 14, 2023September 9, 2024

The knowledge gained through appropriately designed development studies culminates in the establishment of a control strategy. As shown in the picture, control strategy could include three levels of controls as follows: Level 1 utilizes automatic engineering control to monitor the CQAs of the output materials in real time. This level of control is the…

QbD

Process Design and Understanding in QbD

Byipharmacist December 9, 2023September 9, 2024

A pharmaceutical manufacturing process usually consists of a series of unit operations to produce the desired quality product. Unit operations may be executed in batch mode or in a continuous manufacturing process. A process is generally considered well-understood when: (1) all critical sources of variability are identified and explained (2) variability is managed…