Analytical Instrument Qualification - Live Online Training
15-17 November 2022
Course No. 20381
Speakers
Jörg Kastenschmidt
Merck Healthcare
Roland Miksche
MiRo Consulting
Philip Lienbacher
Takeda
All times mentioned are CET.
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.
The objective of this Live Online Training 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
Practical examples and exercises will allow the participants to discuss key areas of interest.
Target Group
This Live Online Training 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.
Technical Requirements
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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)
PRACTICAL EXAMPLES I Topic: Apparatus & Instruments List Case Study / Risk Categorisation According to USP <1058>
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
PRACTICAL EXAMPLES II Topic: Qualification / Risk Analysis of pH Measuring Instruments
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-Visible - 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)
PRACTICAL EXAMPLES III Topic: Balances
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
Life cycle phases and documentation: - Requirements phase - Definition, build phase - Testing phase - Release - Changes, decommissioning
Literature (regulations, guidances)
PRACTICAL EXAMPLES IV Topic: Validation of Excel Spreadsheets (Categorisation, responsibilities, required documents, contents of documents, testing, versioning, data handling)
Q&A Sessions Q&A sessions ensure interaction and that your questions are answered.
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
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Seminar Programme as PDF