Commun Interest Group - GICs

• The Analytical GIC will continue its work in 2026 on Analytical Procedure Lifecycle Management (APLM), in line with the recently adopted ICH Q2(R2) and ICH Q14 guidelines. The objective is to move beyond the traditional development/validation/transfer approach towards a continuous lifecycle strategy based on scientific knowledge, a thorough understanding and control of analytical procedures, and quality risk management to ensure the control of critical quality attributes (CQAs). A GST guide on this topic will be published soon.
• March 2026: Comments on European Pharmacopoeia Chapter 5.38.
• January 2026: Comments on USP <1225>.
• September 2025: Comments on USP <1221>.
• March 2025: event Product Life Cycle
• July 2025: Comments on ICH Q1.
• May 2025: Comments on USP Chapter <1058> – Analytical Instrument Qualification.
• March 2025: A3P Product Lifecycle event in Lyon.
• 2024: Four webinars on ICH Q2(R2) – Validation of Analytical Procedures and ICH Q14 – Analytical Procedure Development, as well as comments on USP <1220> – Analytical Procedure Lifecycle.
• June 2023: Publication of a guide based on the concepts and tools introduced in USP <1220>, released ahead of the final publication of ICH Q14 and ICH Q2(R2).
• March 2022: Submission of comments on the Step 2 drafts of ICH Q14 and ICH Q2(R2).
• November 2021: Submission of comments on USP <1220> – Analytical Procedure Lifecycle.

• The A3P Barrier Technologies GIC addresses the complexity and diversity of aseptic processes by promoting barrier technology solutions tailored to each application. Through collaborative work and the sharing of best practices, the group supports pharmaceutical professionals in optimizing their manufacturing processes while complying with the requirements of EU GMP Annex 1 and international recommendations from organizations such as ISPE, PHSS, and PDA.
• In 2026, the GIC is focusing on four main topics: A study on glove defects (holes) and their impact on aseptic processing. Innovations in barrier technologies, including RTPs, BioTrak®, VHP, and related technologies. Routine manufacturing under ISO cleanroom and RABS environments. Practical implementation of EU GMP Annex 1, including first air, smoke studies, and other critical requirements.
• The group will soon publish two new guides:
  Airflow Visualization Guide.
  Guide on the Management of Non-Sterilizable Cooling Zones in Depyrogenation Tunnels.
• 2026: Publication of GST 28 – Management of Indirect Product Contact Parts in Isolators.
• 2026: La Vague No. 90 article: “When a Hole Changes Everything.”
• June 2025: A3P Barrier Technologies Technical Days (conference) in Tours.
• June 2023: A3P Barrier Technologies Technical Days (conference) in Tours.
• September 2021: A3P Barrier Technologies Technical Days (conference) in Tours.
• October 2020: Publication of the La Vague article: “Campaign Manufacturing: A Productivity Advantage for Isolators.”
• November 2019: Development of a practical training module: Visual Inspection of Isolator Gloves and Sleeves (available in French and English, with training sessions held twice a year).
• March 2019: A3P Barrier Technologies Technical Days (conference) in Pau.
• March 2017: A3P Barrier Technologies Technical Days (conference) in Pau.
• January 2017: Publication of the La Vague article: “Securing the Integrity of Your Isolator Gloves.”

• The A3P BFS GIC will continue its work in 2026 on the filling of injectable products using Blow-Fill-Seal (BFS) alternative filling technologies. In a context of increasingly stringent regulatory expectations for BFS processes and growing demand for vaccines and sterile injectable products, it is essential to understand every stage of the BFS filling process, identify and control the critical process parameters, and establish an appropriate level of sterility assurance while optimizing manufacturing costs and timelines.
• 2025: A3P BFS Event in Lyon.
• 2024: Publication of GST 18 – Injectable Blow-Fill-Seal (BFS), a practical guide designed to help manufacturers understand, implement, and sustainably manage BFS technology and its associated manufacturing processes.

• In 2026, the GIC Biotherapies processes will continue its work on phases 3 and 4, and publish a new version of the guide.The GIC’s objective is to propose a decision tree (methodology, rational) to support all high value-added projects, listing the key stages, prerequisites and points of vigilance throughout the development of a Biotherapeutic product.
• 2024: publication of the phases 1 and 2 / ATMP guide GST 20 to identify the issues, levers and pitfalls to be avoided in the development of biotherapies.
• November 2023: Event dedicated to Biotherapy processes, bringing together the main players in the field (start-ups, manufacturers, CDMOs, suppliers & service providers). Addressing the technical and regulatory issues to be considered during development phases (pre-clinical & clinical) to prepare, accelerate and succeed industrialization.

• 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 A3P Cosmetics GIC, launched in October 2024, aims to bring together industry experts and manufacturers to address key topics, harmonize practices, and support cosmetics professionals in implementing the Chinese CSAR (Cosmetic Supervision and Administration Regulation) requirements. A self-assessment guide will soon be published to facilitate compliance with the Chinese CSAR regulation.
• June 2026: Presentation of the group’s work at the A3P Cosmetics event (conference and CSAR workshop).
• June 2025: Presentation of the group’s work at the A3P Cosmetics event (conference).

• The A3P Facilities & HVAC GIC, launched in 2026, is developing a practical guide entitled: “How to Effectively Design Pharmaceutical Manufacturing Facilities (Premises and HVAC Systems) in Compliance with Operational Requirements and Current Regulatory Expectations.”
• The guide will address the following key questions: What are the prerequisites for moving successfully from design to operation? What are the most common design mistakes to avoid? What are the critical points requiring particular attention? How should facility design be adapted to specific manufacturing processes (e.g., BSL-1, BSL-2, etc.)? What are the most effective strategies for contamination control? What is the impact of EU GMP Annex 1 on existing facilities and HVAC installations?

• The A3P GDP GIC, launched in January 2024, addresses the challenges associated with Good Distribution Practices (GDP) and explores practical solutions by reviewing applicable international regulatory requirements, alert procedures, risk management measures for transport deviations (such as temperature excursions), and feedback from participating pharmaceutical companies.
• The objective of the A3P GDP GIC is to develop recommendations and enhance Good Distribution Practices in order to optimize transportation processes and ensure compliance with regulatory requirements. In 2025, the GIC published GST 25 on Carrier Management, which was presented during the Pharmaceutical Distribution event held on June 10, 2026, in Lyon. All conference presentations are available in the members’ area.
• The group is continuing its work on temperature management during storage and distribution.

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”

• In 2026 Cleaning and desinfection GIC is continuing its work with industry professionals on the hygienic design of premises and equipment.
• April 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) and publication of 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 QbD GIC will continue its work in 2026 and has identified 2 themes :
  1. Control Strategy (implementation and follow-up)
  2. Sampling Plan (strategy/justification)
• March 2025: event Product Life Cycle
• 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)”

• The A3P Water GIC will continue its work in 2026, focusing on the overall energy impact of pharmaceutical water production and distribution systems.
• November 2023: Publication of the A3P Water Guide, covering the applicable regulatory framework and the management of pharmaceutical water production systems, including design, production, and monitoring.
• December 2020: Delivery of two webinars on the latest regulatory developments, their impact on the design and maintenance of pharmaceutical water production and distribution systems, and the latest trends in monitoring (presentation materials available in the A3P members’ area).
• May 2019: Submission of comments during the EMA public consultation on the draft guideline entitled “Guideline on the Quality of Water for Pharmaceutical Use.”