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cGMP Compliance Trends in Analytical Laboratories

8 November 2017

Objectives

It is the aim of this course to address all those GMP Compliance issues that are currently discussed as hot topics in analytical quality control laboratories and during GMP-/FDA-Inspections. This course will give an update about the actual regulatory requirements (EU, US, WHO, etc.) and will show how these requirements can be put into practice. In addition this course will look at scientific and regulatory trends to be expected in the future.

Background

Due to changing regulatory requirements pharmaceutical quality control units 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, 21 CFR Part 210/211 (USA), EMA and FDA Guidances, WHO Recommendations and Pharmacopoeias (Ph.Eur., USP, JP).

Laboratory Managers and Analytical Scientists 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. 

Topics that will be addressed are:

  • Current Experiences from GMP Inspections in QC Labs from an GMP Inspectors’ Perspective
  • Forced Compliance: Turning the FDA quality metrics initiative into value for your lab
  • Risk-based Approach to Sampling according to EU GMP Chapter 6 – does QC have to take the sample?
  • Case Study – Handling OOT Results
  • Case Studies: ALCOA Metrics for Data Integrity
  • Update 2017: New challenging ANVISA Requirements to Method Validation and Method Transfer (Brazil)

Target Audience

This conference will be of significant value to

  • Laboratory managers
  • Quality control managers
  • Qualified Persons (QPs)
  • Analytical scientists
  • Senior laboratory staff

from quality control units in the pharmaceutical industry (routine QC and in research and development) who are responsible for GMP Compliance in the analytical laboratory. This course is also intended for employees in Quality Assurance and from contract labs.

Programme

Current Experiences from GMP Inspections in QC Labs
Leo Leineweber, Technical Auditor / Inspector, Münster, Germany

  • Experiences with implementation of chapter 6 of the EC GMP guideline
  • Handling of OOS
  • Transfer of methods
  • Reference substances
  • Sampling

Forced Compliance: Turning the FDA Quality Metrics Initiative into Value for your Lab
Dr. Wolf-Christian Gerstner, Geniu, Hamburg, Germany

  • Background on FDA quality metrics program (short)
  • The effects of forced compliance and the “Forced-compliance-Paradigma”
  • Implications for your QC lab
  • The value of compliance for the lab
  • Approach to derive maximum value out of compliance metrics
  • Pitfalls to avoid when introducing metrics

Risk-based Approach to Sampling
Ulla Bondegaard, Novo Nordisk, Bagsværd, Denmark

  • Sampling plans should be based on a risk management approach (EU GMP Chapter 6)
  • Do the laboratory personnel collect the samples?
  • Requirements to labelling and handling of samples. A practical approach

Case Study – Handling OOT Results
Dr. Lars Lueersen, CSL Behring Recombinant Facility AG, Bern, Switzerland

ALCOA Metrics for Data Integrity
Dr. Danilo Neri, PQE

  • Regulatory expectations set forth in the latest Data Integrity Guidances issued by PIC/S, FDA, MHRA, WHO
  • ALCOA+ control measures recommended to be included in a Data Governance System to be embedded in the Quality System of Life Science companies
  • Assessment of current practices against these measures to identify potential violations to the integrity of Regulated Data and to define risk-based corrective actions, which allow the company to mitigate the resulting Regulatory exposure
  • Case studies related to the data created and managed either on electronic and paper format within the laboratory environment
  • Metric which allow the company to assess the compliance level and monitor the relevant mitigation actions

Update 2017: New challenging ANVISA Requirements to Method Validation and Method Transfer (Brazil)
Ulla Bondegaard, Novo Nordisk, Bagsværd, Denmark

  • New requirements about validation of analytical procedures
  • Extra requirements to method transfer
  • Additional expectations of the Brazilian authorities

Moderators

Ulla Bondegaard, Novo Nordisk, Denmark

Speakers

Ulla Bondegaard, Novo Nordisk, Bagsværd, Denmark
Currently responsible for maintaining cross-organisational (and cross-country) laboratory processes.

Dr. Wolf-Christian Gerstner, Geniu, Hamburg
Managing Director

Leo Leineweber, Technical Auditor/ Inspector, Münster, Germany
Head of laboratory within the Official Medicines Control Laboratory (OMCL) located at the NRW Centre for Health of the federal state Nordrhein-Westfalen.

Dr. Lars Lueersen, CSL Behring Recombinant Facility AG Bern, Switzerland
Senior Manager Chemical Quality Control und Global Tech Transfer PM.

Dr. Danilo Neri, PQE, Italy
Validation Project Manager with expertise on Computer System Validation.