Analytical Instrument Qualification Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

Analytical Instrument Qualification

Vienna, Austria

Course No 20363

This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager". Learn more.

 

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Speakers

Jörg Kastenschmidt, Merck, Germany
Philip Lienbacher, Takeda, Austria
Roland Miksche, MiRo Consulting, Austria

Objectives

Calibration and qualification of equipment are key requirements in GMP guidelines (EU GMP Guide, Annex 15 to EU GMP Guide, and FDA’s Code of Federal Regulations, 21 CFR Part 211). These requirements also apply to instruments and systems in analytical laboratories of the pharmaceutical industry. Besides calibration and qualification, the validation of computerised systems is another key issue. The software components associated with the instruments and systems must be shown to be fit for their intended purpose. Computer validation requirements and guidances for the pharmaceutical industry are laid down, amongst others, by the EU (Annex 11 to EU GMP Guide, the PIC/S (Good Practices for Computerised Systems in Regulated “GXP” Environments”), GAMP® (Good Automated Manufacturing Practice), and FDA’s Part 11.

The United States Pharmacopoeia (USP) has adopted the General Chapter <1058>, Analytical Instrument Qualification, in 2008. This General Chapter <1058> has been updated in 2017 and a new version is coming up soon. 

The objective of this course is to provide the participants with an overview of the regulatory requirements on the qualification of analytical equipment and the software validation of computerised systems and to give practical advice on successful approaches to calibration, qualification, validation, and routine monitoring of instrumentation and systems. Key requirements of the important  USP General Chapter <1058> will be presented and discussed.

The course will cover the following instruments and systems amongst others:
  • UV/VIS Spectrophotometers, Disintegration and
  • Dissolution
  • Balances and Masses
  • pH
  • RAMAN / NIR / FT-IR
  • HPLC and GC
  • Chromatographic Data Systems
  • Excel® - Spreadsheets
Interactive workshops will allow the participants to discuss key areas of interest and to exchange practical experiences.

Target Group

This GMP Education Course will be of practical value to scientists and engineers in analytical laboratories and contract laboratories in an FDA-/GMP-regulated environment who are responsible for the calibration and qualification of their laboratory equipment and for the validation of the computerised systems used in their laboratories.

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.

Programme

Regulatory Aspects of Analytical Instrument Qualification
  • Overview about legislations including
    • Europe: EU GMP Guide - Annex 15
    • US: CFR, USP
    • National: German ZLG quality manual
  • Other relevant documents (Interpretation documents) and authority expectations
  • Overview about qualification steps
  • Equipment life cycle
USP General Chapter <1058> - Analytical Instrument Qualification
  • Key recommendations of this USP General Chapter
  • Qualification steps: which activities should be performed in each phase?
  • Roles and responsibilities for the user, Quality Assurance and for the manufacturer/vendor
  • Software validation, change control & documentation
  • Instrument categories
General Aspects of Calibration
  • Overview: regulatory aspects / requirements
  • Definitions / terminology
  • Concepts and documentation
  • Handling OOC (Out of Calibration)
Risk Assessment in Analytical Laboratories
  • Scaring examples
  • Advantages of minimizing risk
  • Definition and regulation (EU GMP Part 3 - Quality Risk Management, etc.)
  • Approach, applicability, documentation, approvals
  • FMEA (Failure Mode and Effect Analysis)
  • HACCP (Hazard Analysis and Critical Control Points)
  • ISHIKAWA DIAGRAM (Fishbone)
  • FTA (Fault Tree Analysis)
  • Risk assessment of changes
Calibration Management
  • Parts of a calibration management system
    • Procedure(s)
    • Documentation
    • Calibration standards
    • Calibration management software
  • Calibration interval adjustment
  • OOC/OOT evaluation
  • What can go wrong and how to avoid it
Data Integrity Challenges in Calibration and Qualification
  • Relevant Guidelines
  • Documentation & Data Management Systems in the pharma/device industry
  • Achieving data integrity: Creating a culture of quality around document and data management
  • What can go wrong and how to avoid it!
Qualification of Specific Instruments and Systems
  • Requirements according to USP
  • Traceability of standards
  • Practical approaches to qualification and calibration of
    • UV / VIS spectroscopy
    • Dissolution
    • Disintegration
    • Osmometer
    • Particulate matter
    • Turbidity
    • Dishwasher
Qualification of GC Instruments
  • Warning Letters (483) and Findings
  • Technical overview, applications
  • From vendor to decommissioning: AIQ-Lifecycle
  • System suitability test
  • Periodic review (Checklist)
Balances and Weighing Processes
  • Weighing basics
  • Environmental influences on weighing
  • Practical aspect on weighing
  • Requirements acc. to USP <41> and <1251>
  • Qualification and calibration of balances
  • Weights (OIML R111-1)
Qualification of RAMAN / NIR / FT-IR
  • Quick overview RAMAN / NIR / FT-IR & benefits
  • Qualification: What are the specifics?
  • Potential difficulties
Volumetric Apparatus (Pipets, Dispensers, etc.)
  • Selection of suitable apparatuses
  • Qualification / calibration
  • Volumetric laboratory glassware
Assurance of Controlled Temperature and Humidity
  • Thermometers and thermometry
  • Hygrometers and hygrometry
  • Qualification approaches to
    • Refrigerators and freezers
    • Climatic storage rooms and incubators
    • Ovens & muffle furnaces
    • Water baths
General Aspects of Computer Validation in Analytical Laboratories
  • PIC/S Guidance Good Practices for Computerised Systems in Regulated “GXP” Environments
  • New EU GMP Annex 11 Computerised Systems
  • Requirements of 21 CFR Part 11
  • Life cycle concept
  • Integration of equipment qualification and computer validation
  • Retrospective validation
HPLC  / Chromatography Data Systems – Integrated Qualification and Validation
  • Master Validation Plan (MVP)
  • Assessments (Risk to Quality, 21 CFR Part 11)
  • User Requirement Specification (URS)
  • Function- and Design Specification (FS/DS)
  • Risk Analysis (RA)
  • Validation Protocol (VP)
  • Test Cases (Deviations, Incidents, Changes)
  • Final Report (FR)
  • Standard Operation Procedures (SOP)
  • Forms (User Access, Monitoring, Updates...)
  • Service Contracts, helpdesk, logbook
Validation of Excel® Spreadsheets
  • Areas of Usage
  • Known Errors and Findings
  • Categorisation according GAMP
  • Lifecycle phases and documentation:
    • Requirements phase
    • Definition, build phase
    • Testing phase
    • Release
    • Changes, decommissioning
  • Literature (Regulations, guidances)

WORKSHOP I
Topic: Apparatus & Instruments List Case Study / Risk Categorisation According to USP <1058>

WORKSHOP II
Topic: Qualification / Risk Analysis of pH Measuring Instruments

WORKSHOP III
Topic: Balances

WORKSHOP IV
Topic: Validation of Excel Spreadsheets
(Categorisation, responsibilities, required documents, contents of documents, testing, versioning, data handling)

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