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
Background
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.
Target Group
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.
Programme
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
Testimonials