Jörg Kastenschmidt
Merck Healthcare
Referent:innen
Philip Lienbacher
Takeda
All times mentioned are CET.
Zielsetzung
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:
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.
Zielgruppe
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
We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
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>
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
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
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)
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.
Q&A sessions ensure interaction and that your questions are answered.
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