- Starting without a clearly defined QTPP
- Inadequate API characterization
- Copying the reference product without understanding excipient functionality
- Selecting excipients only based on compendial compliance
- Ignoring supplier, grade and batch-to-batch variability
- Changing multiple variables simultaneously
- Relying excessively on trial-and-error experiments
- Not using risk assessment and DoE effectively
- Optimizing only assay and dissolution
- Accepting borderline dissolution profiles
- Using a non-discriminatory dissolution method
- Conducting unrealistic compatibility studies
- Developing the manufacturing process too late
- Failing to document important process observations
- Considering scale-up only at a late stage
- Scaling only based on batch-size ratio
- Ignoring packaging and container-closure interactions
- Starting stability studies too late
- Relying only on accelerated stability data
- Adding excipients without identifying the root cause
- Establishing ranges without adequate scientific evidence
- Developing too close to specification limits
- Weak coordination between formulation and analytical development
- Overfitting DoE or AI models without proper validation
- Skipping confirmation and edge-of-range batches
- Ignoring patient acceptability and administration requirements
- Maintaining inadequate development documentation
The goal should not be merely to develop a batch that passes specifications. It should be to develop a robust formulation and process that consistently performs despite variability in materials, equipment, operators, environment and scale.
Relevant Certification Courses:
Resource Person: Moinuddin Syed , Ph.D , MBA, PMP
