Pharmacopoeias for Beginners
Im Auftrag der ECA Academy

Pharmacopoeias for Beginners Im Auftrag der ECA Academy

Heidelberg, Germany

Seminar Nr. 17003


Kosten

Non ECA Member: EUR 1790,--
ECA-Member: EUR 1590,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Raphael Bar, BR Consulting, formerly with Teva, Israel
Dr Françoise Muffat, Sanofi Pasteur, France
Dr Ulrich Reichert, Merck, Germany
Dr Andreas Trute, Roche, Switzerland

Zielsetzung

When working with the compendia questions that often arise are: When do General Texts apply? What is mandatory / what is flexible? How to implement a compendial procedure? How to handle phamacopoeial reference standards? This Education Course will provide you with support to successfully work with the compendia. The course also includes three interactive workshops and aims at systematically acquainting the participants with:
  • The structure and activities of the USP and Ph. Eur. organization bodies, and other international Pharmacopoeias (including Chinese Pharmacopoeia)
  • Structure of typical monographs
  • General chapters on compendial methodologies
  • General approach to compendial testing
  • Interpreting all tests listed in a monograph
  • Handling pharmacopoeial 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

Hintergrund

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.

In addition, pharmacopoeias are part of the regulations that QPs (Qualified Persons) must comply with for the release of the products as described in the registration dossiers. They also need to manage them in a more and more globalized environment. Therefore, visibility on the on-going drafts and/or work program could be useful for anticipation.

Zielgruppe

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.

Programm

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

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