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Quality by Design (QbD)

QTPP, CQAs, CPPs development with risk analysis and Design of Experiments implementation

Quality by Design (QbD) at VersaK Labs

Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

At VersaK Labs, we implement QbD principles as defined by ICH Q8–Q12 guidelines, building quality into products from the earliest stages rather than relying solely on end-product testing. This approach delivers faster development, reduced failures, cost savings, and smoother regulatory approvals.

1. Overview of QbD

  • Introduction to the QbD philosophy as defined by ICH Q8–Q12
  • Emphasis on building quality into the product from the earliest stages, rather than relying on end-product testing
  • Benefits: faster development, reduced failures, cost savings, smoother regulatory approvals

2. QTPP – Quality Target Product Profile

  • • Defining the intended clinical performance and quality expectations
  • • Linking patient needs to product attributes
  • • Examples: dosage form, route of administration, release profile, stability targets

3. CQAs – Critical Quality Attributes

  • • Identifying measurable attributes that impact safety, efficacy, and stability
  • • Focus on both drug substance (purity, particle size, polymorphs) and drug product (dissolution, uniformity, sterility)
  • • Strategies for risk ranking and prioritization

4. CPPs – Critical Process Parameters

  • • Process parameters that must be controlled to ensure CQAs
  • • Examples: mixing speed, temperature, pH, granulation end-point, lyophilization cycle
  • • Emphasis on robust process design and monitoring

5. Formulation & Process Design

  • • Protocols and Reports: systematic documentation to support regulatory filings
  • • Use of DoE (Design of Experiments) to evaluate formulation variables and process factors
  • • Scale-up considerations, bridging from lab to pilot to commercial scale

6. Risk Management

  • • Application of ICH Q9 principles
  • • Tools such as FMEA (Failure Mode & Effects Analysis), Fishbone Diagrams, Ishikawa Models
  • • Risk mitigation strategies at each stage of development

7. Scale-Up and Process Validation

  • • Bridging studies from R&D to manufacturing scale
  • • Establishing Design Space and Control Strategy
  • • Process validation approaches: PPQ (Process Performance Qualification), CPV (Continued Process Verification)

8. Consulting, Training & DoE Support

  • • Consulting: guidance on regulatory expectations, dossier preparation, and QbD implementation
  • • Training: hands-on workshops for scientists, QA teams, and manufacturing staff
  • • DoE: practical application of screening, optimization, robustness, and scale-up studies

9. Regulatory Alignment

  • • Integration with ICH guidelines (Q8–Q12), FDA QbD expectations, and EMA regulatory frameworks
  • • Support for NDA/ANDA filings, CMC sections, and variations submissions
  • • Audit readiness and data traceability

10. Why Partner with VersaK Labs

  • Experienced in both small molecules and complex biologics
  • Combination of scientific rigor and regulatory insight
  • Tailored solutions for startups, SMEs, and global pharma companies
  • Commitment to accelerating development while reducing risks

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Key Features

  • ICH Q8-Q12 compliance
  • Design of Experiments (DoE)
  • Risk-based development
  • Process validation (PPQ/CPV)
  • Regulatory dossier support
  • Training & consulting

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