Reference Substances of the European Pharmacopoeia – Establishment and Use
- Definition of primary and secondary Standards
- Analytical techniques and methods used for the Establishment
- CRSs for identification Tests
- Impurities and impurity mixtures as CRSs
- Assay Standards
- Collaborative Trials
- Correct use of Pharmacopoeial CRSs
- Storage, manufacture and distribution of CRSs
Qualification, Management, and Use of Reference Standards in Quality Control
- Types of reference Standards
- Certificates and documentation
- Appropriate use of reference standards
- Requirements for commercial reference standards
Reference Standards – GMP Inspector’s Perspective
- Legal requirements in EU
- How to characterize & qualify standards?
- What is expected in EU-GMP inspection?
- Frequent findings
Uncertainty in Content Assignment of Reference Standards
- Measurement uncertainty
- Mass balance approach or assay vs. primary standards?
- To change or not to change – ensuring reference standard stability
Reference Standards – a Laboratory View
- Ordering – where to get them?
- Shipment and storage
- Handling and documentation
- Audit findings
- Optimizing reference standard consumption