ECA Analytical Instrument Qualification
ECA Analytical Instrument Qualification
ECA Analytical Instrument Qualification
Speakers
Analytical Instrument
Jörg Kastenschmidt
Merck, Germany
Qualification
23 – 25 May 2023 | Vienna, Austria
Philip Lienbacher
Takeda, Austria
Roland Miksche
MiRo Consulting, Austria
Image: BÜCHI
Highlights
Regulatory Aspects of Analytical Instrument Qualification
USP General Chapter <1058> - Analytical Instrument Qualification
Risk Assessment in Analytical Laboratories
Calibration Management
Balances and Weighing Processes
Practical Examples of Analytical Instrument Qualification and Calibration:
- Spectroscopic Instruments and Detectors (UV/VIS, IR, NIR, NMR, etc.)
- pH Measuring Instruments
- HPLC / GC
- RAMAN / NIR / FT-IR
- Thermometers and Hygrometers
Computer Validation in Analytical Laboratories
Validation of Excel® Spreadsheets
Data Integrity Challenges in Calibration and Qualification
Participate in 4 Workshops!
Programme
Objective Programme
Calibration and qualification of equipment are key requirements Regulatory Aspects of Analytical Instrument
in GMP guidelines (EU GMP Guide, Annex 15 to EU GMP Guide, Qualification
and FDA’s Code of Federal Regulations, 21 CFR Part 211). These
requirements also apply to instruments and systems in analyti- Overview about legislations including
cal laboratories of the pharmaceutical industry. Besides calibra- - Europe: EU GMP Guide - Annex 15
tion and qualification, the validation of computerised systems is - US: CFR, USP
another key issue. The software components associated with the - National: German ZLG quality manual
instruments and systems must be shown to be fit for their in- Other relevant documents (Interpretation documents)
tended purpose. Computer validation requirements and guid- and authority expectations
ances for the pharmaceutical industry are laid down, amongst Overview about qualification steps
others, by the EU (Annex 11 to EU GMP Guide, the PIC/S (Good Equipment life cycle
Practices for Computerised Systems in Regulated “GXP” Envi-
ronments”), GAMP® (Good Automated Manufacturing Practice), USP General Chapter <1058> - Analytical Instrument
and FDA’s Part 11. Qualification
The United States Pharmacopoeia (USP) has adopted the Gen- Key recommendations of this USP General Chapter
eral Chapter <1058>, Analytical Instrument Qualification, in Qualification steps: which activities should be
2008. This General Chapter <1058> has been updated in 2017 performed in each phase?
and a new version is coming up soon. Roles and responsibilities for the user, quality
assurance and for the manufacturer/vendor
The objective of this course is to provide the participants with an Software validation, change control & documentation
overview of the regulatory requirements on the qualification of Instrument categories
analytical equipment and the software validation of computer-
ised systems and to give practical advice on successful ap- General Aspects of Calibration
proaches to calibration, qualification, validation, and routine
monitoring of instrumentation and systems. Key requirements Overview: regulatory aspects / requirements
of the important USP General Chapter <1058> will be present- Definitions / terminology
ed and discussed. Concepts and documentation
Handling OOC (Out of Calibration)
The course will cover the following instruments and systems
amongst others:
U
V/VIS Spectrophotometers, Disintegration and WORKSHOP I
Dissolution
Balances and Masses Topic: Apparatus & Instruments List Case Study /
pH Risk Categorisation According to USP <1058>
RAMAN / NIR / FT-IR
HPLC and GC
Chromatographic Data Systems
Excel® - Spreadsheets Risk Assessment in Analytical Laboratories
Interactive workshops will allow the participants to discuss key Scaring examples
areas of interest and to exchange practical experiences. Advantages of minimizing risk
Definition and regulation (EU GMP Part 3 - Quality Risk
Management, etc.).
Target Audience Approach, applicability, documentation, approvals
FMEA (Failure Mode and Effect Analysis)
This GMP Education Course will be of practical value to scientists HACCP (Hazard Analysis and Critical Control Points)
and engineers in analytical laboratories and contract laborato- ISHIKAWA DIAGRAM (Fishbone)
ries in an FDA-/GMP-regulated environment who are responsi- FTA (Fault Tree Analysis)
ble for the calibration and qualification of their laboratory equip- Risk assessment of changes
ment and for the validation of the computerised systems used in
their laboratories.
Parts of a calibration management system Quick overview RAMAN / NIR / FT-IR & benefits
- Procedure(s) Qualification: What are the specifics?
- Documentation Potential difficulties
- Calibration standards
- Calibration management software Volumetric Apparatus (Pipets, Dispensers, etc.)
Calibration interval adjustment
OOC/OOT evaluation Selection of suitable apparatuses
What can go wrong and how to avoid it Qualification / calibration
Volumetric laboratory glassware
Data Integrity Challenges in Calibration and
Qualification Assurance of Controlled Temperature and Humidity
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 IV
Jörg Kastenschmidt
Merck, Darmstadt, Germany
Philip Lienbacher
Takeda, Vienna, Austria
Roland Miksche
MiRo Consulting, Vienna, Austria
After more than 15 years driving CSV, data integrity and all global
IT projects within the Quality Assurance Department of Shire, he
implemented EBM, an electronic batch management system, at
Shire and afterwards, as Senior Consultant of HGP Pharma Con-
sulting, at a customer in Germany. He made his final exam in bio-
chemistry in Vienna, Austria, worked as analyst in accredited la-
boratories and as a sales and service expert for scientific
equipment.
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