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

International pharmaceutical regulations, in particular American and European regulations, define the qualities required for pharmaceutical waters (EPU and EPPI).
The major orientations in terms of design are mentioned in various regulations and guidelines.
The rules of the art are more or less known and shared, which makes the repository not sufficiently clear and precise for manufacturers.
The technical choices and technological compromises that result are dictated by several factors.
A risk of overbidding makes the CAPEX & OPEX costs too high and sometimes hinders some judicious investments. On the other hand, in some cases, minimalist conceptual approaches do not allow for a sufficient level of confidence in the facilities.
Moreover, the approach in terms of qualification / requalification is quite disparate depending on the industry and the means implemented.
At the regulatory level, various projects are in progress (EMA, annex 1 GMP ... etc).
Feedback from industry and suppliers will be relevant and will provide the feedback needed for the implementation of pragmatic and efficient texts.
A harmonization of the practices would be appreciable for the industrialists.
A3P has therefore decided to create a GIC on this subject 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.

The objectives of GIC A3P Water for pharmaceutical use:

  • On behalf of A3P, bring the comments of manufacturers and suppliers to the draft issued by the EMA entitled: "Guideline on the quality of water for pharmaceutical use";
  • To establish a practical guide of recommendations for the industrialists on the design of the installations of production, storage and distribution of waters for pharmaceutical use;
  • To establish a comparison of the processes of production of purified water (EPU) and water for injections (EPPI) with notion of TCO by integrating the last regulatory evolutions;
  • Screen disinfection processes and establish comparisons;
  • Propose a cause / action plan logigram for OOS or OOT results;
  • To create an overview of the key issues of the production, storage and distribution facilities for pharmaceutical water UPE and water for injection EPPI;
  • Update on internationally applicable regulatory texts and association guides;
  • Develop a guide for FAT / SAT activities and QC / QI / QO / QP qualification
  • Study the prerequisites for the implementation of predictive maintenance: define the actions to be carried out by proposing a protocol that will allow the collection of monitoring data and their exploitation;
  • Offer a space for technology watch & innovation through scientific articles and summary files for members, via some existing media (The Wave, A3P website ... etc.) or build (newsletter ...);
  • Develop a collaborative platform between users, to anticipate changes and work together on shared standards;
  • Anticipate the different possibilities of communication of the results for the different subjects. In particular, the various speakers are potential speakers for the A3P congress, days of microbiology, or other event.

The group will deal with examples covering all pretreatment processes, UPE and EPPI production, storage and distribution conditions, disinfection / sterilization pathways and quality maintenance at the point of use.
The results of the different topics will be presented at next A3P events in which participants could be invited to comment, possibly interactively, on certain principles and certain orientations emerged.

Apply

CALL FOR APPLICATIONS
the 1 22 in February 2019

  • 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 - April 2019

Production
June 2017

- One-day discussion event in Lyon

  • GIC Active
  • Draft on best practices for heat mapping in freeze-drying
  • The group works on a day of exchange in Lyon in July 2019

Production
October 2017

- One-day discussion event in Lyon

The objectives of this ICG:
The "classical" microbiological methods described in the pharmacopoeia (general chapters and monographs), for some more than 30 years ago, have limits in terms of time, specificity, flow, sensitivity or even reliability of response. To overcome these shortcomings, and with the introduction of the General Chapter 5. 1. 6 "Alternative methods for the control of microbiological quality" in the European Pharmacopoeia in 2008, many alternative methods, based on scientific progress, have been developed and evaluated.

The first methods were developed and used in industry in the 1990 years (impedancemetry, cytometry, mainly bioluminescence).

Some have been "validated" and are still being implemented, others have been optimized since their inception, others have never been used routinely and some have disappeared. Many new technologies have emerged recently for the detection, quantification and identification of microorganisms. Some of them are of particular interest for pharmaceutical companies' control laboratories and could represent major technological advances in the near future.

The creation of a group of common interest (GIC) on the subject of "Alternative Methods in Microbiology" (MAM) allows first of all to draw up an inventory of methods proposed, considered, evaluated, adopted and rejected by the all the laboratories of pharmaceutical manufacturers, so far, with their proven advantages and disadvantages. In a second step, we want to discuss together the issue of validations (ICHQ2) and share concrete examples of validation of some of these methods in order to register the GIC-MAM as a force of proposal to our community. Finally, we want to work in this group, on the approaches used for 1 level performance qualifications, in the quality control laboratories but also directly at the suppliers of these methods, and try to identify relevant examples of achievement that could represent a reference requirement.

Deliverables:

  • Article in the magazine La Vague (special issue state of the art)
  • Creating a validation guide
  • Two special MAM days as part of the AP3 Microbiology meetings in Tours in March 2020

Apply

CALL FOR APPLICATIONS
the 1 22 in February 2019

  • 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
  • GIC Active since July 2018
  • The group is preparing comments for the end of November 2018
  • GIC Active since October 2017
  • Work on the realization of a guide

The various regulations on process validation, published for several years, are based on an integrated approach to the product life cycle. Indeed, 3 key principles are developed:

1- Define and understand the process and the product
2- Validate the process
3- Maintain in validated state the process

It is in the first step: defining and understanding the process and the product that the concept of Quality By Design is developed.

A3P proposes to create a regulatory GIC Quality By Design aiming to provide a practical and technical guide to demystify the concepts presented in the regulations such as the establishment of the QTPP (Quality Target Product Profile), the definition of the critical process parameters and the 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".

We therefore offer you the opportunity to participate in a multidisciplinary working group of about 10 to 15 people bringing together industrialists and developers of the pharmaceutical and biotech industry.

The group will be led by
Elodie Keromnes : Head of Technology Transfer Engineering Group - Capsugel / Lonza
Sandrine Duclos : Validation Expert - Cophaclean
- Anne RIGOULOT (A3P Administrator)

If you are interested and have experience in process validation and process design we invite you to join us by registering below

Apply

CALL FOR APPLICATIONS
the 1 22 in February 2019

  • 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
  • Suggested guidelines (operator training, quality control and use of gloves, etc.)
  • Days of exchanges in Pau where the completion of the work of the ICG in 2016 was exposed

Achievements
Mars 2016

- 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 + XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX by email to vpalombi@aXNUMXpservices.com