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
Content Assignment for Chemical Reference Standards
- Measurement uncertainty
- Mass balance approach or assay vs. primary standards?
- To change or not to change – ensuring reference standard stability
Audits in Quality Control Laboratories focussing on Reference Materials
- Storage, labelling and expiry date of Reference Standards in the QC lab
- Documentation requirements
- Handling and use of Reference Standards in analytical test procedures
- Content of the Reference Standard SOP
- Preparing for an audit in QC labs
- Checklist for Reference Standard procedures
- Reference Material – Examples for non GMP compliance