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QbD Optimization of Crystallization

products-servicesPolyCrystalLine S.R.L.
June 15th 2015


PolyCrystalLine is a leader in applying Quality by Design (QbD) methodology to crystallization optimization and product development.

QbD applied to optimized crystallization

Traditionally, crystallization processes have focused on a combination of Quality Assurance (QA) and Quality Control (QC) approaches. These respectively attempt to assure quality through concentrating on basic process and product inspection.

By contrast, the PolyCrystalLine QbD approach focuses on responding to variation in customer needs to creating products of higher quality and assured safety.

Quality by Design (QbD)

The Quality by Design concept as initially defined by Joseph Juran is based on the concept that it is possible to plan for quality in basic product and process design, shifting the emphasis from removing failures to creating features that reflect actual user needs.

The US Food and Drug Administration (FDA) as adopted this concept as the basis for Pharmaceutical QbD; a platform for the radical improvement of the way drugs are discovered and commercially developed.

The FDA QbD agenda is further expressed in International Conference on Harmonization (ICH) Q8 guidelines that define Pharmaceutical QbD as “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.”

PolyCrystalLine’s ‘quality by design’ approach is firmly based on ICH Q8. Q9 and Q10 guidelines.

Process Analytical Technology (PAT)

Process Analytical Technology (PAT) is an integral element in QbD methodology. PAT provides a system for designing, analyzing and controlling manufacturing through timely measurements of Critical Process Parameters (CPPs).

CPPs directly affect Critical Quality Attributes (CQAs), which in turn measure actual delivered quality.

PolyCrystalLine QbD process for crystal optimization

PolyCrystalLine’s QbD process for crystallization product development follows a six step approach that reflects the original methodology proposed by Juran:

  1. Define the Quality Target Product Profile (QTPP);
  2. Identify potential Critical Quality Attributes (CQAs);
  3. Link Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) to CQAs and perform risk assessment;
  4. Develop an appropriate design space;
  5. Define a proper Control Strategy;
  6. Manage product life cycle, including continuous improvement.

QbD crystallization benefits

Following a QbD approach to crystallization results in processes and products that are more closely tailored to actual uses and markets, delivering powerful commercial advantages.

Once the goal of precisely engineered product is accomplished, PolyCrystalLine can help clients realize the transfer of know-how and specific tools, that enables them to incorporate new test methods into process and create robust control strategies for process and product with reduction of related costs.


Click on QbD Optimization of Crystallization for more information.
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Supplier Information
Supplier: PolyCrystalLine S.R.L.
Address: VIA F.S Fabri, 127/1 40059 – Medicina (Bologna), Italy
Tel: +39 051 6970791
Fax: +39 051 851 847

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