The Common Interest Groups - CIGs

The complexity and diversity of aseptic processes require adapted Barrière Technology solutions for each of them. The work and sharing of good practices by the members of the CIG are intended for professionals in order to optimize their production process by integrating the requirements of Annex 1 and international recommendations (ISPE, PHSS, PDA, ..).
This group is currently working in 2024 on the following 4 subjects: study on holes in gloves, the various innovations linked to barrier technologies (RTP, Biotrak, VHP, etc.), routine production under ISO or RABS, and Annex 1 (first air, smoke studies, etc.) and plans to write articles or practical guides. The group also provides qualifying training to people in the industry, example below for the visual inspection of gloves under isolator.

June 2025: Technical days (conferences) Location to be defined
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”

In a context of increasing health authority requirements regarding BFS (Blow-Fill-Seal) technology and the growing demand for vaccines, it is crucial to understand all the necessary steps for filling injectable solutions, to grasp critical parameters, and to set the sterility assurance level at an appropriate level in order to control manufacturing costs and timelines.

Therefore, A3P has decided to create a Working Group on this subject, enabling various concerned industry stakeholders to exchange information and reach common consensus. The ultimate goal is to develop a practical guide for future BFS operators who must manage this type of process, as well as to present the results of this collaborative work in various formats such as conferences and articles.

Objectives of the A3P BFS Working Group: Define a practical guide for industry professionals to understand and effectively manage this technology and its associated processes in the long term. Publication of this guide is planned for 2024.

The objective of the CIG is to propose a decision tree (methodology, rational) to support all projects with high added value by listing the key stages, prerequisites and points of vigilance throughout the development of a Biotherapy product .​ This guide is being written to identify in particular the issues, levers and pitfalls to avoid in the development of biotherapies.
It will be presented at the next edition of the CIG Biotherapy Processes on November 21, 2024.
November 2023: Event dedicated to Biotherapy processes to bring together the main players in the field (Start-ups, manufacturers, CDMOs, suppliers & service providers). Address the technical and regulatory issues to be considered when of the different development phases (pre-clinical & clinical) to prepare, accelerate and succeed in industrialization.

Since 2022, the working group has evolved to be called “Cleaning & Disinfection” in line with regulatory expectations. It continues its work for professionals in the industry.

• 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.

This new GIC A3P Cosmetics laucnh in October 2024 aims to address these topics of reflection to industrial experts and manufacturers in order to be able to harmonize practices and help cosmetics professionals face the application of the CSAR which requires a technical, regulatory approach , cultural and organizational of the manufacturing of the cosmetic product.
This working group will bring together best practices in risk assessment and analysis of the application of Chinese CSAR regulations. This group will have several objectives including the development of a practical guide of technical recommendations but also regulatory monitoring on the subject and a methodology for self-assessment of the site.
The first work will be presented during the Cosmetics event on June 12 2025 in Lyon.

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”

The transport of pharmaceutical products has major challenges for pharmaceutical companies in terms of meeting their commitments on drug availability, financial issues (cost of destruction, handling of transport anomalies by quality assurance, control of logistics costs, efficiency of their internal processes, etc.) and also a risk in terms of the company’s public image; carriers, for their part, must demonstrate their reliability and rapid control of transport anomalies in order to win and secure their market share.
CIG A3P BPD proposes to tackle some of these issues and the practical means of resolving them through one or more working groups, by taking stock of applicable international regulatory requirements, procedures for alerting and controlling the risk of transport anomalies (temperature excursions, for example), and feedback from participating laboratories.
The main objective of CIG A3P BPD is to develop recommendations and improve Good Practices to optimize transport processes and compliance with regulatory requirements.

Following on from the GIC Remote Audit and the publication of the corresponding Guide, a new need was identified concerning Regulatory Inspections by health authorities and audits. A working group has been formed to address the Inspections & Audits lifecycle and their impact on the healthcare products industry. The main objective of the working group is to develop recommendations and improve Good Practices to optimize inspection and audit processes, whether scheduled or unannounced, and to move towards inspection readiness.

Due to the COVID-19 pandemic, remote audits and inspections have become more widespread. This new mode of evaluation presents advantages beyond health constraints, indicating that it will become more common and complementary to traditional practices. This evaluation format requires adopting new practices, which has raised numerous questions that the members of the working group (GIC) have attempted to address by creating a reference document for both auditors and auditees in the form of a Technical Guide:

• 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”

After publication of the guide in 2022, the group will continue its work and has identified 3 themes for 2024 :

1. Control Strategy (implementation and follow-up)
2. Sampling Plan (strategy/justification)
3. An event is also being prepared for March 19th, 20th 2025 on Product Life Cycle Management.

• 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).

Providing the tools to implement visual inspection processes in the middle of the injectables production chain. A new guideline will present the work of the CIG such as: the qualification of operators for manual visual inspection, the management of a new or the disappearance of an old defect, the matrix approache throughout the qualification of an automatic machine, and the management of a batch potentially heterogeneous. The CIG is also working on organizing an event on visual inspection during which some of the topics in the guide, and many others, will be presented.
November 19-20, 2024: visual inspection event in Lyon
Sept. 2024: publication of new guideline
Oct. 2022: Publication of A3P Guideline : Good practices for the implementation of an automatic visual inspection process for injectable products
Oct. 2022: A3P Annual Congress (PDF conferences workshops A3P member area)

This group works on the subject of water for pharmaceutical use in order to allow the various manufacturers concerned to discuss these questions, and to reach common consensus in order to facilitate the implementation of the EMA Guideline entitled: “Guideline on the quality of water for pharmaceutical use”.

• 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”