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
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
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
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
Transfer of Analytical Methods
- Definition and regulatory requirements
- How to perform a method transfer
- Case studies
- Typical and critical issues
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
Sampling of Raw Materials, Packaging Components, Devices and Finished Products
- What is Acceptance Sampling?
- Sampling of finished product and packaging
- Sampling Attributes vs. sampling by variables
- ISO 2859-1 sampling Standard
- Nonconforming items and non-conformities
- Classification of non-conforming items and non-conformities
- Risks of sampling
- Sampling of starting materials (WHO standard)
- Full testing vs. testing for identity
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
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
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
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)