Quality Control Compliance Manager
Im Auftrag der ECA Academy

24-26 April 2018

Hamburg, Germany

Seminar Nr. 16324

Unser Seminarservice

Kosten

Non-ECA Members:	EUR 1990,--
ECA Members:	EUR 1790,--
EU GMP Inspectorates:	EUR 995,--
APIC Members:	EUR 1890,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Thomas Backensfeld, Bayer AG, Germany

Dr Raphael Bar, BR Consulting, Israel

Mathieu Materne, UCB, Belgium

Sue Mann, Sue Mann Consultancy, UK

Dr Kerstin Pauli, Bayer AG, Germany

Zielsetzung

This Education Course will give a comprehensive overview of the main GMP requirements for quality control laboratories, from a European as well as from the U.S. (FDA) perspective. It is the aim of the course to address the challenges that QC Compliance Managers face today regarding the relevant regulatory requirements and how to successfully implement these requirements in the analytical lab.

Hintergrund

Due to changing regulatory requirements pharmaceutical Quality Control Compliance Managers are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the US, for instance:

EU GMP Guide (Part 1 / Part 2 / Annexes)
21 CFR Part 210/211 (USA)
Guidances (EMA and FDA)
ICH Guidelines
WHO and PIC/S Recommendations
Pharmacopoeias (Ph.Eur., USP)

QC Compliance Managers must be familiar with all these GMP-related topics and must be aware of the latest updates and the current interpretation of all these guidance documents.

In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the US. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities. Key compliance requirements include:

Change control systems
Calibration and qualification of analytical instrument
Reference standards
GMP compliant documentation
Validation of analytical methods
Stability program
Validation of computerised systems
Procedures for handling OOS results

All these key compliance issues will be addressed in this course and the main topics also deepened in workshops.

This year’s programme has been further updated to include the current challenges of Laboratory Data Integrity issues in analytical labs about reporting and invalidating laboratory results.

Please note that the emphasis of this course is on small-molecule pharmaceuticals. The course will not focus on biotech products.

Zielgruppe

This Education Course will be of significant value to

Laboratory managers,
Quality control managers,
Analytical scientists,
Senior laboratory staff

from quality control units in the pharmaceutical industry who are responsible for GMP Compliance in the analytical laboratory.

Programm

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 spectrophotometer, Dissolution apparatus

Sampling

EU GMP Part 1, Chapters 4, 5, 6
EU GMP Part 2, Chapter 7 (7.1 – 7.5)
EU GMP 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 n

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-test (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
Topic II: Validation of Analytical Test Procedures
Topic III: Method Transfer
Topic IV: Sampling of Raw Materials, Packaging Components, Devices and Finished Products – Practicing with the Sampling Standard ISO-2859-1

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Quality Control Compliance ManagerIm Auftrag der ECA Academy