New perspectives on Cross Contamination and Cleaning validation

WEBINAR

Presentation of the new perspectives for the pharmaceutical industry linked to EU GMP Part I Chapter 3 and 5 about prevention of Cross contamination in Production, EU GMP Annex 15 Chapter 10 Cleaning Validation and the EMA Guideline 2018 “EMA/CHMP/CVMP/SWP/246844/2018”.

Course description

This webinar will present all new aspect of the latest regulatory text about pharmacological and toxicological approach with the new HBELs approach, Q&A and outcome associated:

• Guideline on setting Health Based Exposure Limits (HBELs) for use in risk identification in the manufacture of different medicinal products in shared facilities EMA/CHMP/CVMP/SWP/169430/2012
• Draft and final version of Questions and Answers on implementation of risk based prevention of cross contamination in production and “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” EMA/CHMP/CVMP/SWP/246844/2018
• Outcome of public consultation on Questions and Answers on implementation of risk-based prevention of cross contamination in production and “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” EMA/288493/2018

Associated with:

• GMP Part I, Chapter 3 – Production Area (into operation since 1 March 2015)
• GMP Part I, Chapter 5 – Prevention of cross-contamination in production (into operation since 1 March 2015)
• Annex 15, Chapter 10 (into operation since 1 October 2015)

Each document points will be developed and discussed. Comparison between each point will be treated to give to the participants the best view of the regulatory expected point.
Focus will be on the points that have not been retained or modified and the subjects that have been fleshed out or completed in the Q&A or outcome guideline.

The webinar will help people to understand the current context with the inclusion of toxicity data (PDE/ADE) in the calculation of cross-contamination acceptance limits, to understand the implementation of the different risk assessment expected to justify cleaning validation strategy and routine control and to be able to adapt technical and organisational measures for a good contamination management depending on the manufactured products

We will provide answers to the following questions:

• What is HBELs, who define HBELs, how to use HBELs?
• How to manage old limits with new expected limits?
• How to keep only visual inspection in routine control?
• What is expected for visual inspection?
• Segregation of products in dedicated area is sufficient?

Course content

• Regulatory Changes
  • Guideline HBELs (publication date 20 November 2014)
  • GMP Part I, chapter 3 – Production Area (into operation since 1 March 2015)
  • GMP Part I, chapter 5 – Prevention of cross-contamination in production (into operation since 1 March 2015)
  • Annex 15 chapter 10 (into operation since 1 October 2015)
  • Draft Q&A (publication date 15 December 2016)
  • Q&A final version (publication date 19 April 2018)
  • Outcome (publication date 26 July 2018)
• Key topics in the HEBLs Questions & Answers
  • What is HBELs, who define HBELs, how to use HBELs?
  • Difference between PDE and HBEL
  • Cleaning Validation: New expected limits
  • How to keep only visual inspection in routine control?
  • What is expected for Visual inspection?
  • Use of LD50
  • Segregation of products in dedicated area is sufficient?
• Cross Contamination Risk Assessment: Feedback and Set Up of technical and organisational measures commensurate with the risks defined.

Who should attend

• Professionals responsible for all aspects of cleaning validation programs, including development, deployment, and maintenance
• Quality assurance specialists, quality control technicians, regulatory affairs professionals, pharmacologists and toxicologists, validation scientists, and validation service personnel
• Manufacturing supervisors, technical support personnel, and engineers responsible for evaluating cleaning systems, reviewing equipment, and supporting the cleaning validation program on the plant floor
• All levels of management who need to understand the science of cleaning and cleaning validation including the aspects of residue selection, sampling method and analytical detection method validation, limits determination, and strategies for managing multi-product facilities

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