The journey from a drug’s initial concept to its commercial production is not just science—it's a meticulously orchestrated process involving innovation, rigorous testing, and regulatory compliance.
Take a closer look at this comprehensive roadmap that outlines Stages 13 to 21 of pharmaceutical development, highlighting the transition from lab-scale testing to full-scale commercial manufacturing:
Stage 13–14:
It begins with Analytical Evaluation and Process Optimization (PO batch)—fine-tuning formulation and process parameters to ensure the product is viable and scalable.
Stage 15–17:
We then move to Scale-Up and Process Qualification, leading to Pivotal Batch Production, where batches are produced under simulated commercial conditions. This is where theory meets reality.
Stage 18:
Before submission, the product undergoes a Pre-Submission Audit—an essential step to review all raw data, development reports, and ensure that lab notebooks and protocols meet regulatory expectations.
Stage 19 & 19B:
Following a successful audit, the ANDA (Abbreviated New Drug Application) is submitted, accompanied by the Product Development Report, which tells the entire story of the product's development.
Stage 20:
Once approved, three consecutive commercial lots are produced to validate the process. These must match in batch size and active lot number, proving consistency and reproducibility.
Stage 21:
Even after commercialization, the journey doesn’t end. Any major process changes trigger revalidation under SUPAC guidelines to ensure safety and efficacy remain uncompromised.
This end-to-end process is a testament to the dedication of formulation scientists, process engineers, regulatory professionals, and quality teams—all working in unison to bring life-saving therapies to patients.
Read also:
- Molecule to Market | Part I
- Generic Drug Development Process
- Generic Drug Approval Process
- Developing the Formula | Laying the Scientific Foundation
