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
Electronic batch record concept
Designing the move from paper batch records to electronic execution with review by exception.
Challenge
Batch record review took days per batch and most comments concerned documentation errors.
Requirement
A concept for electronic batch records that removes transcription and supports review by exception.
Approach
Analyse review findings, map the paper record, define electronic controls and exception rules, then prototype one product.
Process & execution
- 1Review-finding analysis
- 2Record mapping
- 3Control design
- 4Exception rules
- 5Prototype
- 6Validation strategy
Technology / process
- MES / eBR
- Review by exception
- Electronic signatures
Documentation
- Concept document
- URS
- Validation strategy
Verification
Prototype tested with operators and QA against the defined exception rules.
Outcome / expected benefit
Expected benefit: shorter batch release and fewer documentation deviations.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
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CMO / Manufacturing
CMO technology transfer support
Transferring a granulated tablet process from a development site to a contract manufacturer.
Illustrative use case
Manufacturing / R&D
Pharmaceutical process optimisation
Reducing yield loss and in-process rejections in an oral solid dosage process.
Illustrative use case