Quality by design in pharmaceutical development

Quality by design is a systematic approach to product development, beginning with predefined objectives and emphasis on product, process understanding and controls, based on sound science and quality risk management

In a recent report by Piramal Pharma Solutions the company explains how the emphasis of quality by design (QbD) beginns with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.

The regulatory agencies encourage risk-based approaches and the adoption of QbD principles in drug product development and manufacturing.

Piramal is applying the QbD approach in product development, which is characterised by following principles:

  • designing product and its manufacturing process to meet patient needs with respect to safety and efficacy
  • designing manufacturing process to consistently produce product meeting pre-defined quality criteria
  • understanding impact of input parameters on product quality to adequately build the controls at the critical points in the process

QbD principally is a scientific, logical and preemptive scheme that will incorporate quality control into each and every step of drug development and the manufacturing process.

It is a target-oriented approach, which Piramal defines by the quality target product profile (QTPP) at initial stages of product development.

The QTPP describes the desired performance based on intended clinical aspects, dosage strength, delivery mode, pharmacokinetics, drug product quality criteria and the container closure system. The next step is identification of key elements of QbD.

Click here to download the full paper.

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Piramal Pharma Solutions (more information, website)