The A3P network

More 36 000 professionals from the Pharmaceutical / Biomanufacturing / Medical Devices / Cosmetics sectors.

36 000 PROFESSIONALS

MANUFACTURERS

SUPPLIERS

Manufacturers

Production 37%
Quality 49%
Marketing 62%
regulatory, 91%

suppliers

Marketing 22%
Quality 49%
Production 62%
regulatory, 87%

The Groups of Common Interest (CIG)

TheCommon Interest Group (GIC)aims to bring together manufacturers and suppliers (pharmaceutical and biotechnology sectors) to share practices and questions. An A3P GIC must advance the issues presented. The members of the GIC will carry out a collaborative work around the same theme and will return it during an event A3P or through publications (the magazine La Vague, scientific and technical guide ...).

Objectives & Achievements of the different Groups of Common Interest

  • 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 submission for comment of the "Concept paper on the revision The GIC A1P Annex 2015, made up of around fifteen industrialists and suppliers, is now ready to be ready for use. The 3 GIC has been reactivated. A consensus document in response to the EMA offers the opportunity to comment on this new version of Annex 1.

Production
October 2015

- Proposals to the 2 EMA PICS Concept Paper February 2015
- Survey of industries on Aseptic Practices in collaboration with the ISPE => Return to the International Congress A3P
from Biarritz in November 2016

  • Review of regulatory texts in draft
  • Preparation of questions on inaccurate or misunderstood points in order to submit them to the health authorities to trigger an exchange
  • Explain the approved regulations (production of a guide distributed to the entire profession)

Completed productions
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: "Control of supplier risks and cross-contamination, studies and summary of regulatory developments EU-GMP Part1 Chap. 3 and 5 "

  • Technical reference on the control of visible particles jointly drafted between manufacturers and suppliers

Production
July 2016

- The 10 golden rules of visual inspection

  • Validation standard sharing work, maintenance standard, operational standard related to the use of barrier technologies by integrating international recommendations (ISPE 2005, PHSS 2010) and coherent with the probable orientations of the future GMP Annex 1
  • Identification of the different "Barrier Technology" solutions proposed and identification of any unmet needs
  • Proposal of guides (operator training, control and use of gloves ...)

Production
March 2017

- Days of exchanges in Pau where the outcome of the work of the ICG was exposed

  • New 15 Appendix applicable to 1er October 2015: establish a reading guide and establish a Validation Master Plan as a model
  • Review the regulatory texts relating to Cleaning and the existing international guides
  • Propose model strategies to:
    - search the source data used to calculate the PD values
    - integrate these values ​​for the calculation of the acceptance criteria

Completed productions
June 2018

- Exchange day in Lyon
- Publication in progress of a guide A3P Scientific and Technical

  • 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

- Exchange day in Lyon

  • Faced with the evolution of technologies and modes of "delivery" computing (Cloud, mobile computing ...), the work of the GIC seek to optimize the current methodologies to keep a flexibility and a control adapted to the risks incurred

Production
June 2017

- Exchange day in Lyon

  • Draft on good thermal mapping practices in lyophilization

Production
October 2017

- Exchange day in Lyon

A3P worldwide

An international presence led by local representatives.
The network is animated by events (forums, technical days, conferences, workshops, exhibitions, visits to pharmaceutical sites, ...) in response to the expectations of industry in respect of local conveniences.

Algeria
Belgium
Spain
France
Italy
Morocco
Switzerland
Tunisia