Analytical Instrument Qualification

Analytical Instrument Qualification

Copenhagen, Denmark

Course No 15314


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Jörg Kastenschmidt, Merck, Germany
Judith Kernbichler, Baxalta, Austria
Roland Miksche, Baxalta, 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> is currently under revision.

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
ELISA
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.

Programme

Regulatory Aspects of Analytical Instrument Qualification
Legislation
- Europe: EU GMP Guide - Annex 15
- US: CFR, USP
- International: PIC/S document PI 006-2
- National: German ZLG quality manual
Interpretation documents, FDA expectations
Qualification steps / Equipment life cycle
JUDITH KERNBICHLER, Baxalta, Austria

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
Impact on Laboratory Operations
JUDITH KERNBICHLER, Baxalta, Austria

General Aspects of Calibration
Overview: regulatory aspects / requirements
Definitions / terminology
Concepts and documentation
Handling OOC (Out of Calibration)
JOERG KASTENSCHMIDT, Merck, Germany

Risk Assessment in Analytical Laboratories
Scarring 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
ROLAND MIKSCHE, Baxalta, Austria

Calibration Management
Documentation
Inventory / instrument master data
Calibration scheduling and tracking
Instrument performance history
Calibration standards
Calibration interval adjustment
Out of tolerance evaluation
Supporting calibration management software
JUDITH KERNBICHLER, Baxalta, Austria

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
JOERG KASTENSCHMIDT, Merck, Germany

Qualification of GC Instruments
Warning Letters (483) and Findings
Technical Overview, Applications
From Vendor to Decommissioning: AIQ-Lifecycle
System Suitability Test
Periodic Review (Checklist)
ROLAND MIKSCHE, Baxalta, Austria

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)
JOERG KASTENSCHMIDT, Merck, Germany

Case Study: ELISA Automation
Qualification of automated system
Preventive maintenance and calibration
Potential difficulties
Benefits
JUDITH KERNBICHLER, Baxalta, Austria

Volumentric Apparatus (Pipets, Dispensers, etc.)
Selection of suitable apparati
Qualification / calibration
Volumertric laboratory glasware
JOERG KASTENSCHMIDT, Merck, Germany

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
JOERG KASTENSCHMIDT, Merck, Germany

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
ROLAND MIKSCHE, Baxalta, Austria

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
ROLAND MIKSCHE, Baxalta, Austria

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)
ROLAND MIKSCHE, Baxalta, Austria

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