C.I.G (Common Interest Groups)

The C.I.G (Common Interest Groups) aim to bring together manufacturers and suppliers (from the pharmaceutical and biotechnology sectors) to share practices and questions. An AXNUMXP CIG must advance the issues presented. The members of the CIG will carry out a collaborative work around the same theme and will return it during an event AXNUMXP or through publications (the magazine La Vague, scientific and technical guide ...).

Objectives & achievements of the different CIG

  • GIC Active
  • This group is working on the topic of pharmaceutical waters in order to allow the various industrialists concerned to discuss these issues, and to reach common consensus in order to facilitate the implementation of this guideline
  • Comments on the draft EMA draft: "Guideline on the quality of water for pharmaceutical use"
  • GIC Active
  • In view of ongoing developments in technologies and data "delivery" methods (Cloud, mobile computing, etc.), the aim of the CIG's work is to optimize current methodologies to retain flexibility and control in keeping with the risks involved
  • Preparation of an exchange day in Lyon - 11 Avril 2019

Production
June 2017

April 2019

- One-day discussion event in Lyon

- One-day discussion event in Lyon

  • GIC Active
  • Draft on best practices for heat mapping in freeze-drying
  • The group working on the day A3P freeze drying 4 July 2019

Production
October 2017

- One-day discussion event in Lyon

  • GIC Active
  • This group first of all makes it possible to draw up an inventory of the methods proposed, envisaged, evaluated, adopted and rejected by all the laboratories of the industrialists of the pharmacy with their proven advantages and disadvantages.
  • This group is currently working on creating a validation guide
  • Inactive GIC
  • Technical guidelines on visible particle control drafted jointly between manufacturers and suppliers
  • The 10 golden rules of visual inspection
  • The ICG will be reactivated at the official release of the regulatory text.
  • Following the publication of the 20 December 2017 by PIC / S and EMA of the new version of Annex 1, the GIC Annex 1 created in 2015 (as part of the comment submission of "Concept paper on the revision The GIC A1P Appendix 2015, made up of about fifteen industrialists and suppliers, commented on the fact that it was reactivated by the EMA in 3. comments to the EMA in March 1.

Achievements
March 2018

- Comments submitted on the draft "Annex 1: Manufacture of Sterile Medicinal ProductsFrom the EMA

  • GIC Cloturé
  • Review of draft regulatory texts
  • Preparation of questions on unclear or poorly understood points, so that they can be submitted to the health authorities to initiate discussions
  • Explain approved regulatory texts (production of a guide distributed throughout the sector)

Achievements
October 2016
September 2015

- Response to the public consultation on "Guidance on the Sterilization of the Medicinal Product, Active Substance, Excipient and Primary Container: EMA / CHMP / CVMP / QWP / BWP / 850374 / 2015"
- Publication of an A3P Scientific and Technical Guide: "Controlling supplier and cross-contamination risks, studies and summary of EU-GMP Part1 Chap. 3 and 5 regulatory changes"

  • GIC Active since September 2018
  • The group is working on developing a guide

Achievements
Mars 2019

- Realization of a questionnaire to edit a guide on the implementation of Continued Process Verification (CPV) or On-going Process Verification (OPV)

  • GIC Active since July 2018
  • The group made comments on the ICHQ12 Guideline
  • The group is preparing a day of exchange which will take place in Lyon 19 September 2019

Achievements
November 2018

- Response to the public consultation on the Guideline ICHQ12 "Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management" at EMA

  • GIC Active since October 2017
  • The group has commented on the Guideline "Guidance on 'Reflection Paper on Statistical Literacy for Comparative Assessment of Quality Attributes in Drug Development (EMA / CHMP / 138502 / 2017)"
  • The group took part in the EMA workshop in May 2018 on "Guidance on 'Reflection Paper on Statistical Methodology for Comparative Assessment of Quality Attributes in Drug Development' (EMA / CHMP / 138502 / 2017)"
  • Work on the realization of a guide

Achievements
March 2018

- Response to the public consultation on Guideline on 'Reflection Paper on Statistical Data for Comparative Assessment of Quality Attributes in Drug Development' (EMA / CHMP / 138502 / 2017)

  • GIC Active
  • This group aims to provide a practical and technical guide to demystify the concepts presented in the regulation such as the establishment of the QTPP (Quality Target Product Profile), the definition of critical process parameters and critical quality attributes of the product and the "design space" to develop and validate a robust and capable process with an effective and adapted control strategy
  • This GIC will be complementary to the GIC "CPV Continued Process Verification" and "statistical methodology for the comparative assessment of quality attributes in development"
  • Establish a guide for manufacturers on the deployment, use and maintenance (Life Cycle Management) of single-use solutions
  • Realize an overview of the key issues of the SUS: validation, environmental impact, integrity test, extractables / relarguables ...
  • Develop a collaborative platform between users and providers, in order to anticipate changes and work jointly on shared standards
  • Promote technical solutions using closed systems and containment systems for toxic products

Production
October 2018

- One-day discussion event in Lyon

  • GIC Active
  • Preparation of A3P Days Barrier Technology for March 2019
  • Sharing validation standards, maintenance standards and operational standards relating to the use of barrier technologies, incorporating international guidelines (ISPE 2005, PHSS 2010) and in keeping with the likely positions of the further GMP Annex 1
  • Inventory of the different "Barrier Technology" solutions on offer and identification of any unmet needs
  • Proposal of guides (operator training, control and use of gloves ...

Achievements
Mars 2016

Mars 2019

- Exchange days in Pau

- Exchange days in Pau

  • GIC Active
  • New Annex 15 applicable from 1er October 2015: draft a reading guide and draft a Master Validation Plan for use as a template
  • Review regulatory texts relating to Cleaning and existing international guidelines
  • Propose template strategies for:
    - researching source data used for computing PD values
    - integrating these values for computing acceptance criteria
  • The group has produced a guide

Achievements
June 2018

- One-day discussion event in Lyon
- Publication of an A3P Scientific and Technical Guide

Head of CIG

For questions regarding CIGs, please contact Victoria PALOMBI:

By phone at +33 (0)4 37 28 30 53 by email to vpalombi@a3pservices.com