Manufacturing / CMO
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Illustrative use caseIllustrative use case
CMO technology transfer support
Transferring a granulated tablet process from a development site to a contract manufacturer.
Challenge
Equipment at the receiving site differed in scale and design from the development equipment.
Requirement
A transfer that reproduces product quality at the receiving site with documented equivalence.
Approach
Build the knowledge package, run an equipment gap assessment, agree scale-up adjustments and define acceptance criteria before exhibit batches.
Process & execution
- 1Knowledge package
- 2Gap assessment
- 3Transfer protocol
- 4Trial batch
- 5Exhibit batches
- 6Transfer report
Technology / process
- Fluid bed granulation
- Compression
- Process validation Stage 1–2
Documentation
- Technology transfer protocol
- Equipment comparison
- Batch records
- Transfer report
Verification
Exhibit batch results compared against pre-defined acceptance criteria and development data.
Outcome / expected benefit
Expected benefit: fewer failed batches at transfer and a clear record of what changed and why.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
More use cases
Manufacturing / R&D
Pharmaceutical process optimisation
Reducing yield loss and in-process rejections in an oral solid dosage process.
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Electronic batch record concept
Designing the move from paper batch records to electronic execution with review by exception.
Illustrative use case