In-house Compliance Workshop

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Compliance Workshop 105

Analytical Instrument Qualification (AIQ) According to USP Chapter <1058>

Understanding and Implementing FDA and USP Requirements

Course objectives

• Understand regulatory requirements for analytical instrument qualification
• Understand the process throughout the entire qualification lifecycle
• Learn how to effectively implement instrument qualification in laboratories
• Learn how to document instrument qualification for FDA and equivalent international agencies

Contents Overview

• FDA and EU analytical instrument requirements
• Most common inspection problems
• The new USP Chapter on Analytical Instrument Qualification
• The GAMP Laboratory Systems Validation Guide
• Essential steps for AIQ: DQ, IQ, OQ, PQ
• Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification
• Recommendations for firmware and software validation
• Roles and responsibilities: QA, manufacturer, user
• Approach for automated systems
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
• What documents should be available for the FDA
• Recommendations for effective implementation
• Type and frequency of tests for 20+ instruments

Detailed Agenda

FDA and International Requirements and Enforcement

• FDA and international regulations
• Inspection and enforcement practices
• Industry practices and trends
• USP chapter <1058>
• GAMP Good Practices Guide for Validation of Laboratory Systems

Going through the qualification process (I)

• Qualification lifecycle approaches; 4Q and V-model
• Qualification planning
• Vendor assessment
• Writing specifications
• Design qualification
• Installation testing and environmental monitoring
• Formal documenting of installation (IQ)

Going through the qualification process (II)

• Testing for operation (OQ)
• Requalification: time and event based
• Performance qualification
• Equipment maintenance: planned vs. unplanned
• Qualification summary report
• Managing and documenting changes
• Workshops and examples

Qualification of systems with different complexity

• Instrument categories according to GAMP and USP
• Qualification of simple equipment through quality processes:
  glass pipettes, stirrers
• Qualification of instruments with local controllers
• Qualification and validation of computerized systems
• Qualification of firmware
• Responsibilities

Managing Changes

• Procedures for planned and unplanned changes
• Changes vs. maintenance activities
• What to test after changes
• Changing hardware, firmware, specifications
• Changing location, application and use of the equipment
• How to document changes

Documentation Requirements

• Overview of required documents
• Developing SOPs for equipment qualification and maintenance
• Developing test scripts
• Documents for lifecycle qualification: qualification plan, DQ, IQ, OQ, PQ, summary report

Going through 20+ instruments

Tested functions, test frequency, acceptance criteria for

• Chromatography (GC, LC, GC Headspace, LC/MS, GC/MS)
• UV, Dissolution, IR
• Ovens, refrigerator
• pH-meter, Refractometer

Collaborative Exercises, Discussions and Examples

Practical examples, case studies and collaborative exercises will be dispersed into and between the presentations. At least 50% will be dedicated to practical sessions with life examples. The outcome will be made available for all attendees on a special workshop reference website. Practical sessions include:

• Workshop: Vendor assessment for different types of equipment
• Workshop: Developing requirement specifications
• Examples: qualification plan, documenting Installation (IQ)
• Workshop: Testing equipment for operational qualification
• Workshop: Performance Qualification
• Example: Qualification summary report
• Qualification tasks for equipment with different complexity
• Workshop: Define tasks and steps for different change scenarios
• List of validation tasks and associated deliverables along the equipment life. What needs to be done and documented when?
• Case study: Going through an example package for equipment qualification
• Example: Table with 20+ instruments, includes functions to be tested, test frequency and acceptance criteria
• Case study: Detailed test protocols for different instruments

10+ Reference documents for easy Implementation

The documents can be downloaded from a dedicated seminar website. They include

• Equipment validation master plan
• SOPS
  - User Requirement Specifications (URS) for analytical equipment
  - Generation and maintenance of SOPs for laboratory equipment
  - Change control for analytical equipment
  - Qualification of equipment
  - Maintenance 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
  - DQ/IQ/OQ/PQ HPLC Systems
  - Equipment hardware identification
• Reference papers
  - Equipment Qualification in Practice
  - Selecting parameters and limits for equipment operational qualification
• FDA Presentation on Equipment Qualification, includes acceptance criteria
• Warning letters and Inspectional observations related to analytical instrument qualification

Who should attend

• Everybody dealing with analytical instruments working in FDA and other regulated environments
• 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
• Teachers

About the speaker: Dr. Ludwig Huber

• Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
• Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Equipment
• Presenter of the Year of the Institute for Validation and Technology
  Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
• Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
• For more information on Ludwig Huber, click here.

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.