Developing a pharmaceutical product isn’t just about creating a pill—it’s a comprehensive and highly regulated process to ensure safety, efficacy, and quality. The image above illustrates a 12-stage flowchart from the Handbook of Pharmaceutical Generics, guiding how solid dosage forms are developed. Let’s explore each step
1. Stage 1 – Literature Search
The development process begins with a deep dive into existing scientific and clinical literature. This helps understand the innovator’s formulation, regulatory guidelines, and critical quality attributes.
2. Stage 2 – Active Sourcing
Identifying reliable sources for active pharmaceutical ingredients (APIs). At least two suppliers must be approved to ensure continuity and quality.
3. Stage 3 – Active Evaluation
The sourced APIs are evaluated based on physicochemical properties and compared against the innovator’s impurity profile (as per ICH guideline Q3A).
4. Stage 4 – Active Purchasing
Selected API batches are purchased for further testing. This begins the journey of hands-on analysis.
5. Stage 5 – Active Testing
Rigorous testing is conducted on the purchased actives. It is crucial to only use production-grade actives, not R&D samples, for valid results.
6. Stage 6 – Innovator Product Purchasing
The innovator’s product is purchased to benchmark quality. This is critical for bioequivalence and comparative studies.
7. Stage 7 – Innovator Product Testing
The reference product undergoes testing to analyze release profiles, dissolution rates, and other critical attributes.
8. Stage 8 – Bulk Active Testing
Larger quantities of API are tested to ensure consistency in performance as the scale increases.
9. Stage 9 – Excipient Evaluation
Excipients (inactive ingredients) are assessed for compatibility with the API and their impact on stability, release, and manufacturability.
10. Stage 10 – Container Closure System Choices
Selecting appropriate packaging that protects product integrity, maintains stability, and meets regulatory requirements.
11. Stage 11 – Manufacturing Process Evaluation
The manufacturing process is carefully developed and optimized for scalability and compliance with GMP standards.
12. Stage 12 – Bulk Active Purchase
Once the process is validated, bulk quantities of API are purchased for full-scale production.
This flowchart reflects the meticulous planning and cross-functional collaboration required in pharmaceutical development. Every stage adds a layer of assurance, leading to a product that is safe, effective, and compliant
Takeaway:
Drug development is a blend of science, regulation, and strategy. Each step is non-negotiable in ensuring the final product meets the highest standards for patient safety and performance.
Read also:
- Molecule to Market | Part II
- Generic Drug Development Process
- Generic Drug Approval Process
- Developing the Formula | Laying the Scientific Foundation
