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Equipment Qualification, includes recommendations for test parameters acceptance criteria

Horacio Pappa: <1058>, Analytical Instrument Qualification, Status and content.  


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 192

Understanding the New USP <1058> for Analytical Instrument Qualification

With SOPs, Templates and Examples for Easy Implementation


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Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify or requalify, test and document. The main reason is that unlike for computer system validation there are no clear guidelines for instrument qualification. This has changed. The USP has released the final version for analytical instrument qualification (AIQ). So pharmaceutical companies are advised to learn about the content and FDA's expectation for instrument qualification. When implemented right the standard also helps to reduce overall qualification costs. Therefore there is lots of interest in learning about the new standard

Key Questions related to USP <1058> analytical instrument qualification are:

  • What do FDA and other regulations say about equipment qualification?
  • What exactly are the expectations of inspectors?
  • Where can I get the latest USP <1058> draft?
  • What qualification model does the USP standard follow?
  • How to systematically define instrument categories A, B and C?
  • What steps are included in analytical instrument qualification?
  • Which procedures should be available for the three categories?
  • Which qualification documents should be generated for each category?
  • We already have procedures for equipment qualification, should we change them?
  • What exactly should be in each qualification phase: DQ, IQ, OQ, PQ
  • What and how much should be tested?
  • How to qualify firmware?
  • What to test after changes, e.g., when the equipment is moved, repaired or updated?
  • How to implement the standard most effectively?
  • How can existing instruments be qualified?
  • How should I document instrument qualification?

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 an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

  • FDA and EU analytical instrument requirements
  • Most common inspection problems
  • Terminology, scope and principles of the new standard
  • AIQ and its relation to method validation, system suitability testing and quality control checks
  • Essential steps for AIQ: DQ, IQ, OQ, PQ
  • Purpose and contents design qualification, installation qualification, operational qualification, performance qualification
  • Allocation instruments to the three categories A, B and C
  • Procedures and validation deliverables for the three categories
  • Recommendations for firmware and software validation
  • Roles and responsibilities: QA, manufacturer, user
  • Approach for automated systems (incl. firmware/computer systems)
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  • Recommendations for effective implementation

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

  • Nine example SOPs:
    - Allocating Analytical Instruments to USP <1058> categories
    - Procedures and deliverables for USP <1058> categories
    - User Requirement Specifications (URS) for analytical equipment
    - Change control for analytical equipment
    - Qualification of equipment
    - Qualification of analytical balances
    - Qualification of refrigerators
    - Development and maintenance of test scripts for analytical systems
    - Validation of laboratory computer systems
  • Templates/examples:
    - Validation plan, URS, DQ
    - Vendor assessment
    - IQ, OQ, PQ
    - Validation summary report
  • Warning letters and Inspectional observations related to laboratory equipment qualification.
  • Publications
    -:Equipment Qualification in Practice
    - Selecting parameters and limits for equipment operational qualification
  • FDA Presentation on Equipment Qualification, includes acceptance criteria
  • USP presentation: <1058> Analytical Instrument Qualification

Who should attend?

  • Laboratory managers and staff
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
  • Validation specialists
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants

How to order

Replaced by the more recent seminar

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Click here

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.