Programme Day 1
09.00 – 09.15 h Welcome and Introduction
Session 1: Introduction to Pharmacopoeial Testing
09.15 – 10.15 h
Structure, General Methods and challenges of Ph. Eur.
10.15 – 11.00 h
Structure, monographs and activities of USP
- Structure of Ph. Eur. and USP
- Meeting Pharmacopoeial standards and Pharmacopoeial Designation
- The USP approach: Single Testing
- Structure of USP monographs:
- modern monograph
- flexible monograph
- Structure of European Pharmacopoeia
- Structure of Ph. Eur. monographs
- What the Pharmacopoeia does not say about a procedure
- Dietary Supplements, API and CEP of Ph. Eur.
- Mechanisms of harmonisation between Pharmacopoeias
11.00 – 11.15 h Coffee break
11.15 – 12.15 h
Additional Pharmacopoeias around the world – Japan, China, India, Int. Ph. (WHO), BP
- Historical developments
- The development of the International Pharmacopoeia
- JP, ChP, Russian Ph., and IP – similarities and differences
- Legal status and enforcement
- WHO Good pharmacopoeial Practices
12.15 – 12.45 h Q&A Session 1
12.45 – 13.45 h Lunch break
Session 2: Important Monographs: Harmonisation, Differences, Solutions
13.45 – 14.45 h
Pharmacopoeial policy of impurities testing
- Which impurities are controlled?
- Analytical techniques and general texts/monographs
- Control of organic impurities
- What about validation?
14.45 – 15.30 h
Analytical Instrument Qualification according to Ph. Eur. and USP
- USP General Chapter <1058> Analytical Instrument Qualification and Ph. Eur.
- Type of instruments and risk assessment
- Qualification steps: DQ, IQ, OQ and PQ
- Roles and responsibilities
- Computerized data systems in laboratory
- Examples: Qualification of HPLC and analytical balances
15.30 – 15.45 h Coffee Break
15.45 – 16.30 h
Life cycle approach to compendial methods
- Draft USP chapter <1220> & Measurement Uncertainty
- USP Chapters <1224>, <1225>, <1226>
- Analytical Target Profile and Analytical Control Strategy
- ICH Q2(R2) Revision
- ICH Q14 Analytical Procedure Development
16.30 – 17.00 h Q&A Session 2
Programme Day 2
Session 3: Dealing with testing challenges
08.30 – 09.15 h
General Notices – Definitions and Requirements
- Use of alternative procedures & interchangeable methods
- Waivers to the obligation to perform all tests
- Scope of general monographs
- Definitions
09.15 – 10.15 h
Reference Standards - similarities and differences
- Definitions and guidelines
- Legal status of reference standards
- Types of standards
- Establishment and use/Testing and value assignment
- Similarities and differences between pharmacopoeias
10.15 – 10.30 h Coffee Break
10.30 – 11.30 h
Verification of Compendial Procedures
- Difference between Verification and Transfer of an analytical procedure
- Chemical vs microbiological procedures
- Minimal performance characteristics to be verified
- What to verify in procedures for high-level (Assay by HPLC) and low-level analytes (Impurities by HPLC and TLC)
- When procedure verification is not required
- ISO 17025 requirements for method verification
- Documentation of procedure verification
11.30 – 12.00 h Q&A Session 3
12.00 – 13.00 h Lunch Break
13.00 – 14.00 h
Multicompendial Testing Strategies
- Divergent and conflicting pharmacopoeial requirements
- CDER’s MAPP 5310.7 “Acceptability of Standards from Alternative Compendia”
- How to proceed in case of missing harmonization?
- Full Testing, Worst Case Testing, Alternative Testing
- How to proof equivalence?
14.00 – 14.45 h
Case Studies: Meeting Challenges of Pharmacopoeial Compliance
14.45 – 15.00 h Coffee Break
15.00 – 16.00 h
Alternative methods to pharmacopoeial methods: Equivalence testing of two methods
- Is a compendial procedure equivalent to an in-house validated procedure?
- Critical performance characteristics to be compared
- Plotting the results of comparative testing
- Traditional way of comparison of two procedures
- Equivalence testing with two one-sided t-test (TOST)
16.00 – 16.30 h Q&A Session 4 / End of the course