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H. Pappa: USP General Chapters and the Quality of Analytical Measurements

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them


Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 191

Understanding USP Documents and Reference Standards

General Chapters, General Notices, Monographs, Forum, Reference Standards


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The Unites States Pharmacopeia is a non-governmental organization. Nevertheless USP is not only important for laboratories in the United States but on  global basis. The reason is that companies marketing drug products in the US must follow USP or equivalent methods. The USP offers a variety of documents such as monographs, general chapters, general notices and dietary supplements. While general chapters with numbers >1000 have the status, under certain circumstances they also can be mandatory. So many laboratories are unsure on what to do.

Key Questions related to USP are:

  • USP is not a governmental organization. What is the legal basis for USP?
  • What is the relationship between USP and FDA?
  • What is the difference between NF and USP monographs?
  • What is the role of the Pharmacopeia Forum (PF)
  • What is the meaning of general notices?
  • What is the difference between General Chapters above and below 1000?
  • Do we always have to to follow USP standards?
  • We are following EP standards, is this accepted by the FDA?
  • What if there is no USP standard?
  • What is the status of harmonizing Pharmacopeias in US/Europe and Japan?
  • Our company operates in Europe. Do we have to follow USP monographs?
  • Do we have to validate USP methods in our laboratory?
  • What is the process to develop monographs?
  • US reference standards are quite expensive. Can we use our own standards?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • History, mission and scope of USP
  • Legal basis for FDA mandating to follow USP procedures
  • FDA warning letters related to USP monographs
  • USP Monographs vs. NF Monographs
  • The Pharmacopeia Forum
  • General notices
  • General chapters <1000 and >1000
  • Situations when general chapters above 1000 must be followed
  • General chapters along the analytical process from sampling to data interpretation
  • The standard setting process
  • The Pharmacopoeial harmonization process and outcomes
  • USP reference standards and alternatives 

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs
    - System Suitability Testing in Chromatography (USP Chapter 621)
    - Validation of Analytical Methods (USP Chapter 1225)
    - Verification of compendial methods  (USP Chapter 1226)
    - Equipment Qualification (USP Chapter 1058)
  • Templates/Checklist:
    - Validation of Analytical Methods
    - Laboratory Audits with focus on USP requirements
  • Reference Articles
    - Qualification and Certification of Certified Reference Material and Working Standards 
  • Five Warning letters and/or Inspectional observations related to USP monographs
  • USP Presentation
    H. Pappa: USP General Chapters and the Quality of Analytical Measurements

Who should attend?

  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants

How to order

Pick one of the options in the table that fits your needs. 

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars


Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.