Dr Raphael Bar, BR Consulting, formerly with Teva, Israel
Dr Ulrich Reichert, Merck, Germany
Dr Andreas Trute, Roche, Switzerland
This course aims at systematically acquainting the beginner with:
- The structure and activities of the USP and Ph. Eur. organization bodies
- Structure of typical monographs
- General chapters on compendial methodologies
- General approach to compendial testing
- Interpreting all tests listed in a monograph
- Handling phamacopeial reference standards
- Implementing a compendial procedure described in a monograph
- Fundamentals of compendial chromatography
- Proper use of analytical balances and weighing
- Qualification of laboratory instruments
US and European pharmacopoeias are independent organizations that set the standards for determining the quality of pharmaceutical products marketed in the US or Europe. These standards govern the quality, strength, purity and potency of active pharmaceutical ingredients, dosage forms and excipients as well as many reagents and solutions used to test these materials.
However, sometimes the pharmacopoeias differ in the quality requirements for the same product or raw material. Compliance, therefore, becomes a major challenge for pharmaceutical companies.
USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States and they are recognized and used in more than 130 countries around the globe. The Ph. Eur. is legally binding in 38 European countries and used in over 100 countries worldwide. No wonder then that both pharmacopoeias are widely used by the pharmaceutical industry. Any pharmaceutical testing laboratory must be capable of applying the tests described in the compendial monographs.
This course is tailored to beginners and newcomers to pharmaceutical analysis in a regulated laboratory as well as experienced personnel who wish to learn about the recent changes introduced in the USP and Ph. Eur. Furthermore, the course is useful for R&D Laboratory data analysts utilizing pharmacopoeial tests, QA involved in reviewing analytical data, and RA personnel who wish to learn about the pharmacopoeial quality standards.
About USP and EP Pharmacopeias
- Structure of organizations
- Structure of USP
- USP on line
- Pharmacopeial Forum
- Structure of Ph. Eur.
- Ph. Eur. on line
General Chapters / General Texts / General Monographs
- General notices of USP
- General notices of Ph. Eur.
- Alternative procedures
Reagents and Solutions
- Ph. Eur.
- What is mandatory?
- What is flexible?
Certificate of Suitability of Monographs of the European Pharmacopoeia (CEP)
- USP and Ph. Eur. requirements for reagents
- Types of solutions (test vs. volumetric solutions)
Structure & Examples for Monographs including WORKSHOPS
- Role of the CEP
- How to achieve
Interpretation of USP and Ph. Eur. monographs of:
Balances and analytical weighing
- An active substance
- A finished drug product
- A biologic
Analytical Instrument Qualification according to Ph. Eur. and USP
- USP Chapters <41>, <1251>
- Determination of Repeatability and accuracy of balances
- Determination of minimum weight
- From volumetric to gravimetric sample preparation
Pharmacopoeial reference standards
- USP General Chapter <1058> Analytical Instrument Qualification
- Type of instruments and risk assessment
- Qualification steps: URS, DQ, IQ, OQ and PQ
- Computerized data systems in laboratory
- Examples: Qualification of HPLC and a Spectrophotometer
Compendial Testing Approach
- Types of reference standards
- USP reference standards
- Ph. Eur. and BP reference standards
- Qualification of secondary reference standard
- Re-use of reference standards?
- The four categories of USP tests
- Verification / Validation of compendial procedures
- Singlet testing
- Reportable result
- When an article is of pharmacopoeial quality
- Harmonization process
ICH Impurity Guidelines and their incorporation into the Ph. Eur.
- Chapter <621> and Ph. Eur. 2.2.46
- System suitability requirements
- Quantitation of impurities
- Adjustments of method parameters
- Strategies to demonstrate pharmacopoeial compliance
- 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