Regulatory Requirements for Analytical Labs and QC (EU and US)
- EU GMP Guide Part 1
- EU GMP Guide Part 2
- US 21 CFR Part 210/211
- FDA Guidances for Industry with relevance for labs
- Inspection of analytical labs (EMA, FDA, etc.)
- FDA Warning Letters relating to QC
Analytical Instrument Qualification
- USP General Chapter <1058> Analytical Instrument Qualification
- Risk Analysis
- Qualification steps: DQ/IQ/OQ/PQ
- Practical Qualification of typical instruments such as
- Balances
- HPLC
- UV
- Dissolution
Sampling
- EU GMP Part 1, Chapters 4, 5, 6
- EU GMP Part 2, Chapter 7 (7.1 – 7.5)
- EU GMP Draft Chapter 4
- Statistical sampling – requirements and interpretation
- EU GMP Annex 8
- EU GMP Annex 19
- US / FDA requirements
- WHO
- PIC/S
- ISO (former Military Standard)
Documentation in QC Laboratories
- Regulatory requirements (EU / US)
- Specifications, test procedures, SOPs, etc.
- Handling of data (paper, electronic, hybrid)
- Laboratory Data Integrity
- Analytical results (raw data, raw data check, averaging, rounding of results)
- Case Studies
- Laboratory Data Integrity issues related to documentation - issues to be aware of
The Analytical Aspects of Laboratory Data Integrity
- Overview of deficiencies in laboratory data integrity
- Structure of a typical assay in a QC laboratory
- When system suitability requirements are not met
- Is there a system suitability test based on samples?
- When sample variability criteria are not met
- QC samples for method validity check
- Integration of chromatographic peaks: Automated versus manual
- Reprocessing of raw data and re-integration
- Accepting or invalidating test results?
- Review of audit trail of an analytical run
Lifecycle Approach to Analytical Procedures
- Developing robust, stability indicating methods
- Analytical Target Profile
- Implementation of QbD in development of analytical methods
- Life-cycle of an analytical method
- Are we estimating the real method precision?
- The concept of Assay Format
Handling and Qualification of Primary and Secondary Chromatographic Reference Standards
- Procedure for qualification of a primary reference Standard
- Procedure for qualification of a secondary reference standard
- Pharmacopeial standards: handling and re-use
- Will the certified reference standards (CRM) come to the QC lab?
- Assigning purity values to reference standards
- Calculation examples of assigning purity
Managing Out of Specification and Out of Trend Results
- OOS / OOE / OOT
- FDA and MHRA Guidance
- Reportable Value
- Case Study: Practical approach for handling OOS results
- Issues with OOT results and how to manage these
Computer Validation and Integrity of Electronic Data in Analytical Labs
- Regulatory requirements (EU Annex 11 / US 21 CFR Part 11)
- GAMP / GAMP Laboratory Guide
- PIC/S Guide Computerised Systems in GXP Environments
- Validation of Excel spreadsheets
- UCB Case Study: Implementation of a computerised system at UCB from IT infrastructure components to final VSR and periodic review
- Facilitating and ensuring data integrity through validated paperless processes
Presenting and Evaluating Stability Data
- Overview of ICH storage programs for new drugs
- Generic drugs
- Presenting stability data
- Derivation of shelf life according to ICH Q1E
Transfer of Analytical Methods
- Definition and regulatory requirements
- How to perform a method transfer
- Case studies
- Typical and critical issues
Method Comparison – Equivalence Testing of Two Methods
- Is a newly issued pharmacopeial method equivalent to an in-house validated and practiced method?
- Traditional way of comparison
- Equivalence testing with two one-sided t-tests (TOST)
- Examples
QA Aspects in QC
(relevant for QC Compliance Managers)
- Defining responsibilities for analysts, head of analytical lab, QPs (EU and US)
- Release of APIS, excipients, packaging materials, finished products, etc.
- Contract Labs
- CAPA (Corrective Actions and Preventive Actions)
- Change Control (regulatory framework)
- PQR
- Training (GMP training / training on the job, training records)
Four Workshops
Some of the most important laboratory compliance topics will be further discussed in interactive workshops:
Topic I: Analytical Instrument Qualification
Moderator: Dr Thomas Backensfeld
Topic II: Method Transfer
Moderator: Dr Bernd Renger
Topic III: Validation of Analytical Test Procedures
Moderator: Dr Raphael Bar
Topic IV: Sampling of Raw Materials, Packaging Components, Devices and Finished Products – Practicing with the Sampling Standard ISO-2859-1
Moderator: Dr Raphael Bar