A3P International Congress

The design, qualification and control/monitoring of production facilities are key elements in the control of patient risk for aseptic products. How can the link be made between premises dedicated to aseptic production, Quality Risk Management (QRM) and the "Contamination Control Strategy" described in Annex 1 of the GMP? This workshop will be animated to exchange on this topic in reference to European and American GMPs as well as reference guides and standards (ASTM E2500, guidance for industry,...).

The first part of the workshop will be devoted to describing and commenting on the current regulatory requirements for defining an out-of-specification, out-of-bounds and out-of-trend result. After the definition of the different types of out-of-specification or out-of-limit results expected depending on the type of test and the context, a review of the available literature on the subject will be carried out. Participants will then work in groups on concrete cases of analytical or microbiological OOS/OOT results.
They will carry out the investigation process in the laboratory, taking into account the regulations in force and the European and American guides. Concrete examples may be submitted by participants at the time of registration to be discussed during the workshop. Restitution of the work of each group and handing over of all the supports on USB key at the end of the workshop.

The objective is to go over fundamental specificities of the pharmaceutical industry that are essential for future managers or executives in practice. This workshop will develop essential topics. The topics covered will be: water and its different pharmaceutical qualities, air treatment in clean rooms (laminar flow, insulators, RABS), structures of controlled environments (partitions, ceilings, airlocks, ...), control laboratories (quality control, physico-chemistry and microbiology) and regulatory aspects (GMP, ICH, FDA, ...). Manufacturers will also talk about their professional experience. This workshop is primarily intended for A3P Tremplin students but also for industrialists or suppliers who would like to review some fundamentals.

The purpose of this workshop in English is to offer discussions, practical demonstrations with real equipment and possibly proposals for updating preventive maintenance or training plans, as well as potential impacts on the aseptic process simulation activities. This workshop studies different real cases that actually caused contamination, in connection with sterile production (focus EU GMP Annex 1). We will also offer an exchange session between participants on the concept of Contamination Control Strategy (focus EU GMP Annex 1).
This workshop is intended for everyone, intermediate to experienced level, and must allow participants to exchange and discover various situations that can take place anywhere, even « at home » ... In realistic conditions, the workshop leads participants to discover a contamination situation which has occurred elsewhere, to seek together not the direct causes but the root causes of the deviation in order of course to prevent them effectively to occur again. To this end, suggestions arising from the root causes will be proposed. The workshop will not fail whenever it is possible to illustrate feedback with the expectations of the new appendix 1

Objectives of the workshop and the list of topics covered during the workshop
The objective of the workshop is to cover case studies as well as current strategies in the industry for contamination control. The audience will be given case studies and have an opportunity to implement the 5 Whys, risk-based thinking, and fishbone (Ishikawa) diagrams to come up with potential viable root causes. The attendees will also have an opportunity to play a contamination control Jeopardy Game with the winning team being crowned grand champion and the greatest of all time. Attendees will learn about case studies in contamination control, risk-based thinking, the latest global industry regulations impacting contamination control. The attendees will experience hands on exercises at determining the potential root causes in case studies.
-What the attendees will expect to learn and reminding that this is interactive with subgroup activities.

The attendees will experience a hands-on interactive experience with the Jeopardy game and hands on exercise with contamination control case study root cause analysis. The audience will have an interactive environment to share their experiences and knowledge with the workshop class.
- Which profile should attend this workshop?
• Validation Managers
• Quality Control Managers
• Quality Assurance Managers
• Lean Managers
• Operations Managers
• Cleanroom Managers
• Regulatory Affairs Managers
• Production Managers

- Workshop format:
This workshop will include a Jeopardy competition along with an interactive slide presentation and case studies for each group. We will have the following eight categories in the Jeopardy competition related to contamination control: viral safety, cleaning and disinfection, spores, aging facilities, data integrity, environmental monitoring, disinfectant validation, and root causes. There will be ten questions in each category with an answer to each question. There will be more difficult questions in each category with higher point values. At the end of the competition will come a final Jeopardy question where each audience member can decide how many points they wish to wager on the final question. If there is a tie at the end there will be a playoff question. The winner will receive a prize and a certificate for being the overall competition winner. The questions in each category will have a points value and will go from easier questions to more difficult questions at the end of each category. The audience will truly have a very interactive and educational experience and we expect full audience participation. The presenters will work together on designing and developing the content of each question and the answer that most appropriately fits the designed question. We would expect high audience participation and an overall great informative and educational experience. "

The workshop will provide an update on US and European regulations on the subject of disinfection for both RABS and isolator configurations. In November next year, we will certainly have significant progress on the future Annex 1. We will talk about format parts, cap feeding bowls and all parts in indirect contact on the filling line, such as the bottle accumulation tables at the exit of the depyrogenation tunnels but also gloves and cuffs for example.

It has been 2, 3 years that questions have been asked during the congress on these themes and the answers are not simple. In the last annex 1, there is also the topic concerning the relevance of airborne disinfection versus autoclave sterilization which we will also be addressed.

The idea is to implement a cleaning and disinfection strategy for all surfaces under a filling line of injectables in isolator and RABS.

We will propose practical exercises to deal with the different surfaces involved.

Many people wonder how to define an efficient and cost-effective approach to commissioning and qualification so that they do not routinely undergo the project and then routinely undergo the equipment and utilities. Through this workshop we will exchange via concrete cases (equipment and utilities), on the different stages of a project (Project Risk Analysis, definition of the need, specifications, commissioning tests, qualification tests...) on the points of vigilance and on the key factors of success.

Applicability: Sterile, non-sterile, biotech...

After a decoding of LEAN (reminder of episode 1 = workshop 2019), participants will join a pharmaceutical company in which the problems are not solved .... It's up to you to solve them !
The objective will be to find together the "right" LEAN tools to improve the company's performance !

Theoretical part :
Regulatory reminder
State of the art in the design of water production/distribution facilities for pharmaceutical use
Regulatory adaptation and change control
Relabelling HPW vs Purified Water/WFI + Monitoring and qualification role
Workshop part : Design of an WFI production/distribution facility incorporating new regulatory trends
You will create a Decision flow diagram for the design of a WFI production/distribution plant

With the simultaneous impetus of the FDA in 2015 and the USP in 2018, the philosophy of method validations, integrated into a life cycle of analytical methods, is changing. How do these changes fit into the regulatory requirements of ICH Q2(R1), what can be expected from the ICH group on ICH Q14 and ICH Q2(R2)? These questions will be discussed during this workshop, around the fundamentals of analytical validation.

Experimental designs are nowadays more and more used in industries to understand processes and methods (development of active ingredients, manufacturing processes, etc.). In the pharmaceutical industry, the ICH Q8 and ICH Q11 guidelines cover the pharmaceutical development and manufacturing of an active substance. They require an understanding of the performance of a new product and a justification of control strategies to reduce post-approval submissions. Design of experiments are tools recommended by these guidelines. It is therefore desirable that an expert in the pharmaceutical industry has a basic understanding of design of experiments. This workshop will be devoted to: - a review of basic statistics; - an explanation of the design of experiments approach (definition of the objective, classification of the factors: critical, fixed and noise; identification of responses...). In this context, it is essential to list the constraints encountered; - Some experimental designs will be presented, as well as their interpretations.
Concrete examples, a water loop, cleaning of a tank, zoning plan etc, will be implemented through this workshop and will serve the explanations given, The objective is to make this workshop interactive with the participants so that it is they who ultimately find the solutions and implement them through the concrete example.

Six Sigma methods have long provided many industries with the necessary tools to solve problems, standardize their processes, and positively impact product quality.
Through this interactive session, we will seek to provide guidance on solving the data integrity problem and demonstrate to our industry that:
• Utilizing an organized, risk-based approach to closing human error gaps in your processes allows to prove that the data used to determine product quality is integral and accurate.
• Examining real-world examples from the industry allows for the evaluation of your own processes for unnecessary data integrity and human error risks.
New technologies play an increasingly important role in reducing a laboratory’s risk to human error and data integrity

Example of concrete cases, feedback, practical application.
1 year after the first edition, take part in this workshop to discover the solutions deployed on industrial sites and work in groups to complete your knowledge. Also, benefit from additional feedback compared to the first edition. Digital , Digital , Digital. This term is heard everywhere, but what is the situation today in pharmaceutical plants? Which solutions are really operational, useful for the teams and for which benefits?

Participants will discover the solutions deployed on industrial sites and will work in groups to complete their knowledge.
3 concrete cases of interest to the industry will be presented:
• Digital and virtual reality training for operators
• Digital solutions for QC labs and how to succeed in their deployments
• Electronic batch record for production
During the morning, as an introduction, the leaders will present an overview of the solutions and quality and regulatory requirements for such projects, as well as the key success factors in project management and change management.
This introduction will be based on feedback from projects carried out by major groups in the pharmaceutical industry with whom Altran was able to work in 2019 and will roll out deployments in 2020.
These feedbacks will therefore be reinforced by the richness of these collaborations both in the initial phases of designing digital solutions, and in their implementation and appropriation by operators.

  At the end of the morning and during the afternoon, each participant will join a sub-group:
• Digital training: the group will define approaches and solutions to train operators in Class A/B.
• QC 4.0: the group will share on digital solutions for QC labs, such as LIMS /ELN solutions, augmented reality applications, data management and data analytics,...for QC labs.
• Electronic batch record: the group will work on the preparation of a draft electronic batch record.
The leaders will assist the sub-groups with pedagogical and playful approaches and with their knowledge.
Each group will share the synthesis of its work to all the participants.
This workshop is intended for production, quality, QC, engineering, HR and site managers, who will be able to participate in the sub-group according to their functions and aspirations.
Participants will acquire knowledge that they will be able to put into practice in their companies.
A strong emphasis will be placed on interaction, creativity and sharing among participants.

After having established the basis for the control of a manufacturing process, defined the robustness indicators and identified the principles of action to be taken, a strategy will be built to implement a controlled process.
This strategy will begin with an analysis of the process indicators in their initial state, will continue with a process risk analysis, the definition of a new control strategy, the implementation of regulatory actions (validation, submission) and will end with the implementation of monitoring actions in order to ensure continuous control of the process.