The Common Interest Groups - CIGs

June 2025: Technical days (conferences) in Tours
June 2023: Technical Days (conferences) in Tours
September 2021: Technical Days (conferences) in Tours
October 2020: Creation of an article in La Vague: The campaign is winning! Working in campaign mode, a step forward in the productivity of insulators.
November 2019: Creation of a practical training module: Visual inspection of gloves and cuffs under isolator
March 2019: Technical Days (conferences) in Pau
March 2017: Technical Days (conferences) in Pau
January 2017: Creation of an article in La Vague: Secure the confinement of your gloves
March 2015: Technical Days (conferences) in Pau”

• April 3-4, 2024: Cleaning & Biocleaning event which will therefore talk about the control of surface decontamination and will return in particular to the indirect contact parts of our Barrier Technologies without forgetting the fundamentals of cleaning validation (program link).
• March 2022: A3P Cleaning Validation Conference (conference available on the A3P member area)
• March 2022: Practical GMP Guideline – Annex 15 Qualification & Validation Chapter 10 Cleaning Validation
• June 2021: A3P Cleaning Validation Conference (conference available on the A3P member area)
• June 2018: A3P Cleaning Validation Conference (conference available on the A3P member area)
• July 2017: Articles published in La Vague magazine.

The work of this Working Group has been completed.

• November 2017: Publication of an A3P Scientific and Technical Guide: “Control of supplier risks and cross contamination Survey and summary of regulatory changes EU-GMP Part.1 Chap. 3 and 5“
• October 2016: Response to the public consultation on “Guidance on the sterilisation of the medicinal product, active substance, excipient and primary container: EMA/CHMP/CVMP/QWP/BWP/850374/2015”

• 2024 : A3P Technical Guide “Remote Audit“

Lifecycle management of analytical methods appeared in the Pharmacopeial Forum in 2013 (PF39(5)).
The USP proposed a USP 1220 draft chapter in 2020, which was the origin of the creation of this CIG.
The objectives of the CIG A3P Life Cycle of an analytical method are to present in 2024, in the form of 4 to 5 webinars, the main points of the guide published in June 2023 and the new ICH texts.
• webinar #1 – April 26, 2024: ICH Q2(R2) – Validation of analytical procedures
• webinar #2 – June 14, 2024: ICHQ14 – Analytical procedure development
• webinar #3 & #4 – 2nd semester: ICH Q2R2 / ICHQ14: valorization and sharing of knowledge, routine monitoring of methods.
The opportunity to collect your expectations for the 2nd version of the guide planned soon.
The GIC will also participate in the drafting of comments on new regulatory texts (for example USP chapter <1220> “Analytical Procedure Life Cycle”, which will follow the edition of the ICH guidelines).

The main area of ​​work concerns the management of the life cycle of analytical procedures, confirmed by the recent ICH Q2(R2) and Q14 guidelines, in order to replace the development/validation/transfer trilogy with a continuous approach, based on knowledge, mastery of established analytical technique, as well as risk analysis, to control critical product attributes.

June 2023: Publication of a guide based on the tools proposed by USP1220 and was published before the final version of the ICH texts (ICHQ14 and ICHQ2(R2)).
March 2022: Comments on the ICH texts (ICHQ14 and ICHQ2(R2)) step 2
November 2021: Comments on USP chapter <1220> “Analytical Procedure Life Cycle”

1. Control Strategy (implementation and follow-up)
2. Sampling Plan (strategy/justification)

• 2023: Article La Vague n°78 “”How to build a risk-adapted sampling strategy“” + presentations at the Biarritz International Congress : 2 conferences + 2 workshops
• February 2022: Technical & Scientific Guide “QbD: an approach aimed at gaining a better understanding of the process, so as to better manage it rather than suffer from it (Stages 1 & 2)”

Particulate Risk Management in Injectable Products

The Particles GIC is the first one created within A3P. It served as a model, and the statutes were drafted to function as other GICs, with the collaboration of experts and the possibility to create sub-working groups. The GIC delivered various outputs, including recommendations, technical documents, and monographs.

The Particles GIC was established in 2013 and was led by Alain EUZEN until 2017. Throughout its existence, the GIC obtained the real collaboration of over 70 experts, whom we sincerely thank for their contributions. They were willing to share their practices, engage in technical discussions, and review and work on tests related to standardization. It was a substantial and beneficial effort for the entire A3P community and beyond. Participants from different European countries (France, Belgium, Switzerland, Germany) showed great commitment.

Given the magnitude of the task and numerous requests following regulatory inspections, the GIC structured itself into four sub-working groups:

• Sub-Group 1: Primary packaging and transportation, distinguishing between glass articles, elastomers, and disposables or single-use systems (led by François FONVIELLE – Sanofi Pasteur and Benoît LUX – Lilly France).
• Sub-Group 2: Manufacturing and distribution (led by Alain EUZEN – Sanofi Pasteur).
• Sub-Group 3: Visual inspection (Romain VEILLON – GSK Vaccines).
• Sub-Group 4: Complaints, market recalls, and overall statistical data (Patrick TURLIER – GSK).

Thus, the GIC developed a comprehensive understanding of the particulate issue in injectable products.

Knowledge and progress sharing by the GIC took place during four Particles Forums in Le Vaudreuil (Eure) and Lyon between 2013 and 2016, as well as through numerous publications in La Vague and conference presentations (Biarritz Congress, Pharmaceutical Industry Days in Lille, SFSTP seminar in Paris).

• January 2024: the group continues its work on the theme of controlling contamination of water loops
• November 2023: publication of the Water Guide bringing together all applicable regulations and management of production facilities (design, production and monitoring).
• December 2020: Conducted two webinars on the latest regulatory developments, their impacts on the design and maintenance of production and distribution systems, as well as the latest trends in monitoring (PDF materials available in the A3P member area)
• May 2019: Response to the public consultation on the draft issued by the EMA titled “Guideline on the quality of water for pharmaceutical use”