About the World Pharmacopoeias
- World Pharmacopoeias: Ph. Eur., USP, Chinese Ph., other international Pharmacopoeias
- Structure of Ph. Eur. and Ph. Eur. on line
- Structure of USP and USP on line
- Chinese & other International Pharmacopoeias
- Pharmacopeial Forum, Pharmeuropa
- Harmonization between Pharmacopoeias
General Notices
- Why they are important
- General notices of Ph. Eur., General notices of USP, Alternative procedures, …
General Chapters / General Texts / General Monographs
- USP
- Ph. Eur.
- What is mandatory?
- What is flexible?
- When is an article of pharmacopoeial quality?
Structure of USP and Ph. Eur. Monographs
- Examples for Monographs
- Technical and style guides
- Knowledge database
WORKSHOPS
Hands on Interpretation of USP and Ph. Eur. monographs of:
- An active substance
- A finished drug product
- A biologic
Balances and analytical weighing
- USP Chapters <41>, <1251>
- Determination of Repeatability and accuracy of balances
- Determination of minimum weight
- From volumetric to gravimetric sample preparation
Introduction into Analytical Instrument Qualification according to Ph. Eur. and USP
- USP General Chapter <1058> Analytical Instrument Qualification
- Type of instruments and risk assessment
- Qualification steps: URS, DQ, IQ, OQ and PQ
Reagents, Solutions & Pharmacopoeial reference standards
- USP and Ph. Eur. requirements for reagents
- Types of solutions (test vs. volumetric solutions)
- Types of reference standards
- USP reference standards
- Ph. Eur. and BP reference standards
- Qualification of secondary reference standard
- Re-use of reference standards?
Compendial Testing Approach
- The four categories of USP tests
- Verification / Validation of compendial procedures
- Singlet testing
- Reportable result
- When is an article of pharmacopoeial quality?
Frequently applied Pharmacopoeial Methods
Pharmacopoeial requirements on tests such as
- Clarity and colour of solution
- pH
- KF titration (validation)
- Frequent wet chemistry tests
Compendial chromatography
- Chapter <621> and Ph. Eur. 2.2.46
- System suitability requirements
- Quantitation of impurities
- Adjustments of method parameters
- Strategies to demonstrate pharmacopoeial compliance
ICH Guidelines and their incorporation into the Ph. Eur., with a focus on the Impurity guidelines
- ICH Q3A on Drug Substance Related Impurities
- ICH Q3B on Drug Product Degradation Products
- ICH Q3C on Residual Solvents
- ICH Q3D on Elemental Impurities
- ICH M7 on potentially mutagenic Impurities