Global Product Development | Key Steps and Common Mistakes

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1. Product Identification & Target Market Definition

Steps:

  • Identify target regions (US, EU, UK, Australia, MENA, ROW) and corresponding regulatory pathways (ANDA, MAA)
  • Evaluate patent landscape, RLD/RS availability, bioequivalence feasibility, and market attractiveness.
  • Conduct cost–market–API (CMA) assessments for prioritization.

Common Mistakes:

  • Selecting products without confirming RLD source or BE feasibility.
  • Ignoring pharmacopoeial differences (BP vs. USP).
  • Over-estimating market exclusivity or neglecting patent challenges.

2. API and Excipient Selection

Steps:

  • Choose DMF-listed API suppliers with reliable QMS.
  • Match physicochemical and biopharmaceutical properties (solubility, PSD, polymorphism) to formulation needs.
  • Qualify global excipient sources for regional filings.

Common Mistakes:

  • Ignoring BCS classification implications.
  • Using different excipient grades for early vs. exhibit batches.
  • Lack of cross-regional alignment on API–excipient compatibility data.

3. Formulation Development

Steps:

  • Apply QbD principles (ICH Q8–Q10) to define CMAs, CPPs, and CQAs.
  • Use DOE to establish design space and control strategy.
  • Benchmark formulation attributes with RLD.

Common Mistakes:

  • Trial-and-error rather than structured DOE.
  • Improper dissolution media selection for BE prediction.
  • Unoptimized process parameters leading to poor scale-up.

4. Analytical Development

Steps:

  • Develop and validate stability-indicating methods.
  • Align specifications with ICH Q6A and regional pharmacopeias.
  • Ensure comparative profiling with RLD for assay, content uniformity, dissolution, and impurities.

Common Mistakes:

  • Incomplete method transfer packages.
  • Variations in analytical conditions between R&D and plant.
  • Lack of equivalency justification during transfer.

5. Stability and Compatibility Studies

Steps:

  • Conduct ICH Q1A(R2)-compliant studies across climatic zones.
  • Perform API–excipient compatibility under stress.
  • Apply risk-based bracketing/matrixing where applicable.

Common Mistakes:

  • Relying on short-term stability data for submissions.
  • Ignoring Zone IVb studies (MENA/ROW).
  • Inconsistent correlation between pilot and exhibit batch data.

6. Process Optimization and Scale-Up

Steps:

  • Validate mixing, granulation, coating, and homogenization parameters.
  • Execute validation batches under commercial-like conditions.

Common Mistakes:

  • Equipment mismatch between R&D and manufacturing.
  • No CPP–CQA linkage verification after scale-up.
  • Missing feedback loop for process improvement.

7. Bioequivalence and Clinical Studies

Steps:

  • Choose BE sites approved by the target authority (MHRA, USFDA, etc.).
  • Use biowaivers for BCS I/III where justified.
  • Design IVIVC for SR/MR formulations.

Common Mistakes:

  • BE failure due to unmatched release profiles or food-effect issues.
  • Composition mismatch between BE and exhibit batches.
  • Poor documentation for sample accountability.


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Resource Person: Moinuddin Syed. Ph.D, PMP®

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