Quality Control Compliance Manager

Quality Control Compliance Manager

Berlin, Germany

Course No 15889


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Thomas Backensfeld, Bayer Pharma AG, Germany

Dr Raphael Bar, BR Consulting, Israel

Eric De Maesschalck, UCB, Belgium

Sue Mann, Sue Mann Consultancy, UK

Dr Kerstin Pauli, Bayer Pharma AG, Germany

Objectives

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.

Background

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.

Target Group

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.

Programme

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
Analytical Methods: Development and Validation
  • 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
Stability Testing
  • 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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