Dr Pramod Kumar Pandey BSc (Hons), MSc, PhD, founder of PharmaGuru.co, is a highly experienced Analytical Research Expert with over 31 years in the pharmaceutical industry. He has played a key role in advancing innovation across leading Indian and global pharmaceutical companies. He can be reached at admin@pharmaguru.co
The Lessons Learned approach is a structured process of capturing, analysing, and applying insights from past successes and failures to enhance future projects and prevent the recurrence of mistakes. In the highly regulated and innovation-driven pharmaceutical development, mistakes can be costly, not just financially, but in terms of time, compliance, and patient safety. That’s why […]
Lessons Learned Approach in Pharmaceutical Development: Get Mastery with 7+ FAQs
The Lessons Learned approach is a structured process of capturing, analysing, and applying insights from past successes and failures to enhance future projects and prevent the recurrence of mistakes.
In the highly regulated and innovation-driven pharmaceutical development, mistakes can be costly, not just financially, but in terms of time, compliance, and patient safety. That’s why the Lessons Learned approach has become an essential methodology for ensuring continuous improvement, knowledge retention, and operational excellence across the drug development lifecycle.
Lessons Learned Approach (image: Bing)
Major Takeaway: FAQs
How can lessons learned be used to improve future development?
By guiding better study design, regulatory planning, risk management, and team training.
Who is responsible for managing the lessons learned process?
Project managers, QA, or PMO lead it, but all team members contribute.
How should lessons be documented and shared?
Use structured templates stored in a central system and share in reviews, reports, or trainings
When should lessons learned be captured in a project?
At major milestones (e.g., end of phases), after inspections, deviations, or project completion.
What are typical sources of lessons learned in pharmaceutical development?
Clinical trial issues, manufacturing problems, regulatory feedback, project delays, and team miscommunications.
Is the Lessons Learned Approach helpful in technology transfer?
Yes, the Lessons Learned Approach is very helpful in technology transfer—it helps identify past issues, improve process efficiency, and avoid repeating mistakes during scale-up and site transfer.
What is the Lessons Learned Approach?
The Lessons Learned approach is a systematic process of collecting, documenting, analysing, and applying knowledge gained from past experiences—both successes and failures—to improve future projects and avoid repeating the same mistakes.
In pharmaceutical development, this approach is used across:
It usually involves post-project reviews or retrospective analyses, followed by integration of findings into Standard Operating Procedures (SOPs), training, or risk mitigation plans.
Why is it Important in Pharma Development?
Regulatory Compliance Regulatory bodies like the FDA and EMA emphasize quality management and risk-based approaches. Lessons learned help ensure that GxP (Good Practice) standards are upheld by learning from deviations, audits, and inspections.
Cost and Time Savings By avoiding recurring issues in clinical design, patient recruitment, or scale-up failures, companies save both time and money, critical in an industry where delays can cost millions per day.
Improved Product Quality and Safety By analysing past issues in manufacturing or formulation, teams can implement preventive actions that lead to higher-quality, safer products.
Knowledge Retention Employee turnover is high in the industry. Lessons learned serve as a corporate memory that reduces dependency on individual experience.
Enhanced Cross-Functional Collaboration Reviewing lessons brings together stakeholders from R&D, regulatory affairs, clinical, and manufacturing—improving transparency and communication.
Case Study: Lessons Learned in HPLC Analytical Method Development
Background:
A pharmaceutical company was developing an oral solid dosage form of a new API (Active Pharmaceutical Ingredient). During Phase I clinical development, an HPLC method was developed in-house for routine assay and impurity analysis.
However, once the project moved into Phase II, multiple issues emerged: inconsistent peak shapes, co-eluting impurities, and poor robustness across different instruments and columns at global partner labs.
Problems Identified:
The method had been optimized for a single HPLC system and column brand, lacking robustness testing across vendors and instruments.
Column temperature was not adequately controlled, leading to retention time drift.
Mobile phase pH was not precisely monitored, affecting selectivity.
No formal method lifecycle or risk assessment (e.g., ICH Q8/Q14) had been performed.
Transfer to a CRO lab failed due to undocumented system suitability parameters and unclear sample preparation details.
Lessons Learned:
Method Robustness Needs Early Attention Method parameters such as flow rate, temperature, and pH should have been systematically tested for variability early in development (per ICH Q2 and Q14).
Lifecycle Approach Is Crucial The absence of a method lifecycle plan and lack of design space understanding led to challenges during method transfer and validation.
Documentation Gaps Cause Transfer Failures Sample prep SOPs lacked clarity, and system suitability criteria were not adequately defined, leading to inter-lab inconsistencies.
Column and Equipment Variability Matters Method optimization on a single system/column created reproducibility issues when implemented across global labs.
Corrective Actions Taken:
A full Method Risk Assessment (FMEA) was conducted to identify high-risk variables.
The method was re-developed using Quality by Design (QbD) principles, including Design of Experiments (DoE) to define the method’s design space.
Robustness studies included multiple brands of C18 columns, variation in mobile phase pH, and testing across multiple HPLC systems.
Clear system suitability criteria (e.g., resolution between critical pairs, tailing factor) were defined and validated.
A method lifecycle document was created, covering development, validation, transfer, and routine use.
Knowledge sharing workshops were held to train other analytical teams using the updated method package.
Outcome and Key Takeaway
Outcome
The re-developed method passed validation and was successfully transferred to CRO labs and internal QC teams.
Time spent troubleshooting during method transfer was reduced by 70%.
Regulatory feedback on the submission highlighted the method’s robustness and thorough documentation.
Key Takeaway:
This case highlights how neglecting early-stage robustness and documentation in HPLC method development can lead to costly delays and rework. By applying a Lessons Learned approach, the team institutionalized best practices that are now standard across their analytical development function.
Best Practices for Implementing a Lessons Learned Process
Plan Early: Incorporate lessons learned checkpoints at every major project phase.
Encourage Blame-Free Culture: Foster an environment where teams can honestly discuss failures without fear.
Document Rigorously: Use standardised templates and tools for consistency.
Disseminate Effectively: Make lessons accessible through internal platforms and ensure they are embedded in SOPs and training.
Review and Refresh: Periodically review old lessons to ensure they are still relevant and applied.
Conclusion
In an industry where innovation and regulation walk hand-in-hand, the Lessons Learned approach is not just a reactive strategy—it’s a proactive framework for excellence. Whether preventing a formulation failure or ensuring trial efficiency, institutionalising this mindset can be the key to sustainable success in pharmaceutical development.
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
ICH Q10: Pharmaceutical Quality System
ICH Q8(R2): Pharmaceutical Development International Council for Harmonisation (ICH), 2009 Emphasizes Quality by Design (QbD) and risk-based development.
