A3P Cleaning Validation
Integrate new modifications of European GMPs
Place
Espace Tête d'Or in Lyon
Format
Conferences, round table, interactive workshops, exhibition
Share
Changes to the Chapter 15 Annex 10 of the European GMPs, applicable from the October, 1st 2015 for all pharmaceutical and veterinary drug manufacturers, have considerably strengthened the regulation on the Cleaning Validation.
The latest version of 2001 contained only 7 paragraphs on the subject, when this new version contains 15!
How to integrate this new version on your industrial sites?
How to manage PDE values?
How do health authorities position themselves during inspections?
Since September 2016, the GIC A3P "Cleaning Validation" works on these topics. An interpretation guide is being published. It is intended for all GMP-certified industrial sites as well as cosmetic sites wishing to position themselves in relation to this standard. A3P has decided to dedicate an event on this topic, on June, 5th and 6th in Lyon.
During 2 days, you will have the opportunity to discuss concrete issues through conferences, practical workshops, an exhibition and a round table. The round table will allow GIC members to answer any questions you may have. All sectors (veterinary, pharmaceutical, sterile / non-sterile, cosmetic, biotechnology, biological product ...) are concerned.
Come and take part in this event! We will be happy to discuss with you on a subject in full reflection!
Tuesday June 5
Welcome of participants
08:30
Introduction
Pierre DEVAUX - GIC Validation of Cleaning
08:45
Mastering Cross-Contamination: Risk Analysis
Anne RIGOULOT - SANOFI
09:00
Manual cleaning: mastery and pragmatism
Marie-Véronique MUNEREL - VIRBAC
09:30
Break - Visit the exhibition
10:00
Definition of acceptance criteria including toxicology and multi-site management CMO
Etienne MICHEL - GSK
11:00
Sampling: Methods and sampling plan
Lauriane ZUCHUAT - VIFOR PHARMA
11:30
Interactive Workshops - See the proposed workshops
AMSONIC / HAMO - ANIOS - NOVATEK - NNE - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
12:00
Lunch - Visit of the exhibition
13:00
Interactive Workshops - See the proposed workshops
AMSONIC / HAMO - ANIOS - NOVATEK - NNE- STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
14:30
Interactive Workshops - See the proposed workshops
AMSONIC / HAMO - ANIOS - NOVATEK - NNE - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
15:30
Break - Visit the exhibition
16:30
Validation of cosmetic cleaning: the essentials! Review of the problems and solutions encountered and concrete cases
Marion DUMONT - ECOLAB & Guillaume GARREAU - NESTLE SKIN HEALTH / GALDERMA
17:30
Cleaning validation according to the level of automation
Margaux ARTHUS - ACCINOV
18:00
Cocktail on exhibition
18:30
Wednesday, June 6
Welcome of participants
08:00
The formation of rouging and the usefulness of preventive derouging
Alexandre DE NEEF - GSK & François TOSAR - TECHNOCHIM
08:30
Analytical Strategies for Equipment Cleanup Controls in New Product Development
Solenn JANVIER - SERVIER
09:00
R & D: Verification or prospective approach
Julie BRUNEAU - SANOFI & Elodie PASTRE - UPS CONSULTANTS
09:30
Coffee break - Visit of the exhibition
10:00
Interactive Workshops - See the proposed workshops
AMSONIC / HAMO - ANIOS - NOVATEK - NNE - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
11:00
Interactive Workshops - See the proposed workshops
AMSONIC / HAMO - ANIOS - NOVATEK - NNE - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
12:00
Lunch - Visit of the exhibition
13:00
Maintaining the validated state of the cleaning process: a challenge!
Emilie Sollier - SANOFI PASTEUR & Sandrine DUCLOS - COPHACLEAN
14:30
Coffee break - Visit of the exhibition
15:00
Roundtable - Back to the GIC Guide Appendix 15 Chapter 10
Sophie BOURGOIS - ASPEN, Pierre DEVAUX - UPS CONSULTANTS, Marilyne DOUEZ - NOVO NORDISK, Stéphane MONESTIER - FERRING PHARMACEUTICALS, Julie RACAUD - LABORATOIRE AGUETTANT
With the arrival of the new Annex 15 of the European GMP Eudralex volume IV in October 2015, the cleaning validation process has taken on a whole new dimension in our production activities. Chapter 10, devoted to this subject, has indeed been enriched by 8 additional paragraphs, and this is indeed a major regulatory change! These changes have raised many questions on our industrial sites about the implementation of all these points, for example the case of the value of PDE (Permitted Daily Exposure):"How will we find the source data to calculate this value? Do we only have to rely on toxicological studies? How to calculate this value? Should it be calculated for all products? Is there an obligation to use a "CV Expert" toxicologist for this BMP calculation?..." All attention was focused on this EDP and its practical application as described in the EMA guideline "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities". In these conditions, it seemed opportune to us to create a GIC (Groupe d' Intérêt Commun) A3P Validation du Nettoyage, bringing together industrial experts, producers and suppliers from different sectors (Pharma, Bioproduction, Medical Device, Cosmetics...). The objective of this ICG was to create a guide for the interpretation and implementation of the points of Chapter 10. Through this work and our rich exchange of information, we were able to measure all the difficulties encountered in our organizations in defining and implementing cleaning validation strategies. This is why we wanted to build you a pragmatic guide, a guide that does not claim to be the only solution but a complete work tool to help you define a validation strategy while taking into account the specificities of each of your organizations. In the framework of the Round Table we will come back together on the essential steps discussed in this guide.
15:30
End of the event
17:00
Interactive workshops led by our partners (simultaneous workshops)
1 session: from 12h to 13h
5 June
The parts support basket at the center of the cleaning validation
AMSONIC - HAMO
The parts rack is the heart of the cleaning facility in a pharmaceutical environment. The issues are many: Concerning the parts to be treated: Typology Materials Geometry Positioning Quantities and families of parts Concerning the basket: Ergonomics Handling Loading Cleaning quality Hamo proposes a pragmatic approach of the solution, going from: Dimensional surveys of the parts by scanner 3D Conception and modeling 3D Validation of the basket and the cleaning Documentation validation support
Optimizing cleaning recipes for difficult worst cases
LABORATORIES ANIOS
On the basis of concrete industrial cases concerning dead ends or difficulties of cleaning, we will present the approach that we implement, the criteria to be taken into account and our solutions to solve your cleaning problems.
Design of a launderette in line with the new GMP
NNE
The essential role of a pharmaceutical launderette in a production unit implies compliance with the new requirements of the GMP. The proposed work and exercises aim to find effective technical and organizational solutions. This interactive workshop therefore proposes to understand the stakes and design rules of a GMP-compliant launderette
Change Control and Cleansing Validation: Should I Revalidate or Not? the answer in a few clicks
NOVATEK INTERNATIONAL
NOVA-Cleaning Validation - A Risk Based Contamination Control. Novatek International proposes to centralize all the data associated with cleaning validation in a secure computerized system dedicated to this complex process. In this workshop, we will study various changes that may impact the validation of cleaning such as: change of methods, APIs, products, equipment, cleaning agent, and we will evaluate in a few clicks, through different scenarios, the impacts of these changes on the product definition Worst Case.
Work smart: risk based approach for cleaning validation
STERIS
The presentation will explain the impact of the changes in EU and EMA guidelines regarding cleaning validation. Following that, the presentation will be of great importance to ensure compliance with the international cleaning regulatory. Finally, through a case study (1) , (2) understand the influence of the recovery rate, (3) when visual residue limit could be used only. The risk assessment is validating the numbers of validations run, prioritizing the workload and demonstrating the actual cleaning process in place. Finally, we will share the different types of implementation around the globe.
2 session: from 14h30 to 15h30
5 June
The parts support basket at the center of the cleaning validation
AMSONIC - HAMO
The parts rack is the heart of the cleaning facility in a pharmaceutical environment. The issues are many: Concerning the parts to be treated: Typology Materials Geometry Positioning Quantities and families of parts Concerning the basket: Ergonomics Handling Loading Cleaning quality Hamo proposes a pragmatic approach of the solution, going from: Dimensional surveys of the parts by scanner 3D Conception and modeling 3D Validation of the basket and the cleaning Documentation validation support
New regulatory requirements for cleaning / disinfection in the pharmaceutical and cosmetics industries
LABORATORIES ANIOS
Annex 15, Annex 1, BPR, PDEs for cleaning products, EN standards for assessing the effectiveness of disinfectants ... State of play, impact analysis and proposals for solutions to meet the latest developments in the field regulation of cleaning and disinfection
Design of a launderette in line with the new GMP
NNE
The essential role of a pharmaceutical launderette in a production unit implies compliance with the new requirements of the GMP. The proposed work and exercises aim to find effective technical and organizational solutions. This interactive workshop therefore proposes to understand the stakes and design rules of a GMP-compliant launderette
Change Control and Cleansing Validation: Should I Revalidate or Not? the answer in a few clicks
NOVATEK INTERNATIONAL
NOVA-Cleaning Validation - A Risk Based Contamination Control. Novatek International proposes to centralize all the data associated with cleaning validation in a secure computerized system dedicated to this complex process. In this workshop, we will study various changes that may impact the validation of cleaning such as: change of methods, APIs, products, equipment, cleaning agent, and we will evaluate in a few clicks, through different scenarios, the impacts of these changes on the product definition Worst Case.
Case studies for cleaning optimization
STERIS
Do you have enough of inefficiently cleaning your pharmaceutical production equipment? Contact time too long, repeated cleaning, ratio of detergents too high, chemistries corrosive to your surfaces, impacts on the quality of your products? Do you know that STERIS can help you optimize your cleaning cycles on different applications? Two projects will be presented to you to discuss with you on this theme.
3 session: from 15h30 to 16h30
5 June
The parts support basket at the center of the cleaning validation
AMSONIC - HAMO
The parts rack is the heart of the cleaning facility in a pharmaceutical environment. The issues are many: Concerning the parts to be treated: Typology Materials Geometry Positioning Quantities and families of parts Concerning the basket: Ergonomics Handling Loading Cleaning quality Hamo proposes a pragmatic approach of the solution, going from: Dimensional surveys of the parts by scanner 3D Conception and modeling 3D Validation of the basket and the cleaning Documentation validation support
Criteria to consider when choosing a cleaning / disinfecting product
LABORATORIES ANIOS
How to choose a cleaning agent and a biocidal product, what are the criteria to take into account?
Design of a launderette in line with the new GMP
NNE
The essential role of a pharmaceutical launderette in a production unit implies compliance with the new requirements of the GMP. The proposed work and exercises aim to find effective technical and organizational solutions. This interactive workshop therefore proposes to understand the stakes and design rules of a GMP-compliant launderette
Change Control and Cleansing Validation: Should I Revalidate or Not? the answer in a few clicks
NOVATEK INTERNATIONAL
NOVA-Cleaning Validation - A Risk Based Contamination Control. Novatek International proposes to centralize all the data associated with cleaning validation in a secure computerized system dedicated to this complex process. In this workshop, we will study various changes that may impact the validation of cleaning such as: change of methods, APIs, products, equipment, cleaning agent, and we will evaluate in a few clicks, through different scenarios, the impacts of these changes on the product definition Worst Case.
EU GMP updates Frequently asked questions
STERIS
The presentation covers the impact of the recent changes in cleaning validation guidance, setting limits. In addition, the presentation shares how different manufacturers have implemented the new set of requirements in their systems. Finally, the presentation answers frequently asked questions (FAQ) by pharmaceutical manufacturers. The questions presented are from America and Europe. Finally, different case studies and lessons will be discussed.
4 session: from 11h to 12h
6 June
The parts support basket at the center of the cleaning validation
AMSONIC - HAMO
The parts rack is the heart of the cleaning facility in a pharmaceutical environment. The issues are many: Concerning the parts to be treated: Typology Materials Geometry Positioning Quantities and families of parts Concerning the basket: Ergonomics Handling Loading Cleaning quality Hamo proposes a pragmatic approach of the solution, going from: Dimensional surveys of the parts by scanner 3D Conception and modeling 3D Validation of the basket and the cleaning Documentation validation support
What analytical strategy to put in place for cleaning / disinfecting agents for cleaning validation?
LABORATORIES ANIOS
We will present the analytical methods potentially usable for the research of residues of cleaning / disinfection products; which tracer to choose? which method to choose? From sampling (swabbing, rinsing water) to dosage ...
Evolution of regulatory texts relating to cleaning and validation of cleaning
NNE
The purpose of the current regulatory requirements for cleaning is obviously the absence of contamination of the products by the "equipment" and "local" vectors. This workshop will consist of a rediscovery of these requirements through GMP texts from 1963 to 2017. Participants will be invited to comment on the evolution of the main regulatory texts on the cleaning and validation of equipment cleaning and, more recently, premises.
Change Control and Cleansing Validation: Should I Revalidate or Not? the answer in a few clicks
NOVATEK INTERNATIONAL
NOVA-Cleaning Validation - A Risk Based Contamination Control. Novatek International proposes to centralize all the data associated with cleaning validation in a secure computerized system dedicated to this complex process. In this workshop, we will study various changes that may impact the validation of cleaning such as: change of methods, APIs, products, equipment, cleaning agent, and we will evaluate in a few clicks, through different scenarios, the impacts of these changes on the product definition Worst Case.
Possible applications with the new range of detergents ProKlenz
STERIS
Management of Biofilms, Maintenance and respect of surface conditions, Safety and optimization of manual cleaning ... STERIS offers to discuss these topics through the presentation of the new range of detergents PROKLENZ associated with concrete cases of applications on the sites of pharmaceutical productions.
5 session: from 12h to 13h
6 June
The parts support basket at the center of the cleaning validation
AMSONIC - HAMO
The parts rack is the heart of the cleaning facility in a pharmaceutical environment. The issues are many: Concerning the parts to be treated: Typology Materials Geometry Positioning Quantities and families of parts Concerning the basket: Ergonomics Handling Loading Cleaning quality Hamo proposes a pragmatic approach of the solution, going from: Dimensional surveys of the parts by scanner 3D Conception and modeling 3D Validation of the basket and the cleaning Documentation validation support
Criteria to consider when choosing a cleaning / disinfecting product
LABORATORIES ANIOS
How to choose a cleaning agent and a biocidal product, what are the criteria to take into account?
Evolution of regulatory texts relating to cleaning and validation of cleaning
NNE
The purpose of the current regulatory requirements for cleaning is obviously the absence of contamination of the products by the "equipment" and "local" vectors. This workshop will consist of a rediscovery of these requirements through GMP texts from 1963 to 2017. Participants will be invited to comment on the evolution of the main regulatory texts on the cleaning and validation of equipment cleaning and, more recently, premises.
Change Control and Cleansing Validation: Should I Revalidate or Not? the answer in a few clicks
NOVATEK INTERNATIONAL
NOVA-Cleaning Validation - A Risk Based Contamination Control. Novatek International proposes to centralize all the data associated with cleaning validation in a secure computerized system dedicated to this complex process. In this workshop, we will study various changes that may impact the validation of cleaning such as: change of methods, APIs, products, equipment, cleaning agent, and we will evaluate in a few clicks, through different scenarios, the impacts of these changes on the product definition Worst Case.
Cleaning development - using a Quality by Design Approach - Stop cleaning for long hours
STERIS
The presentation will share a systematic cleaning development method to a science and a risk-based approach for product residue cleaning. The following concept will be discussed during the presentation of the critical quality parameter, the design of space, cycle development. The understanding of this concept is crucial to effective cleaning processes and avoiding the complex cleaning process and long cleaning time. During the presentation, different tools, case studies and lessons learned will be shared with a robust robust cleaning development.
You wish to reserve a stand, please consult our exhibitor file
Plan of the exhibition
| Company | No. Stand | Company | No. Stand | |
| NNE | 1 (partner) | AMSONIC - HAMO | 9(partner) | |
| NOVATEK INTERNATIONAL | 2(partner) | STERIGENE | 10 | |
| COPHACLEAN | 3 | 11 | ||
| CONTEC | 4 | SYMBIOSA ENVIRONMENT | 12 | |
| CARSO | 5 | 13 | ||
| SOCOSUR | 6 | TECNIPLAST - IWT CLEANING EXCELLENCE | 14 | |
| UPS CONSULTANTS | 7 | STERIS | 15(partner) | |
| LABORATORIES ANIOS | 8(partner) |
Services included with the Table Top stand
- A dedicated exhibition space on which you can install your products and communication tools: umbrella stand, roll-up, display, product, ... A basic endowment including table 180 × 80 cm, 2 chairs and 1 electrical connection (2kw ) without a circuit breaker, the loan of a Nespresso coffee machine with pods
- Breaks and meals indicated in the program
- Unlimited WiFi
- A badge that allows you free access to the entire technical and scientific program
- List of participants in the event
- Ability to register an additional person at the special rate "accompanying" (590 € HT)
Contact
According to your requirements and your preferences, you can contact Ludivine BAYLE:
Phone:+33 (0)4 37 28 30 46
Fax: +33 (0)4 37 28 30 60
E-mail : lbayle@a3pservices.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007
On site: 30 rue Pré-Gaudry, Lyon, from Monday to Friday
Accessibility
Private parking (free)
33Louis Guérin Street, 69100 Villeurbanne
Hotel reservation
Mercure Hotel - Lyon Charpennes
7 Place Charles Hernu,
69100 Lyon Villeurbanne
Tel: 04 72 44 46 46
Hotel Crowne Plaza Lyon - Cité Internationale
22 Quai Charles de Gaulle,
69006 Lyon
Tél: 04 78 17 86 86
Lyon Hotel Mariott
The International City,
70 Quai Charles de Gaulle,
69006 Lyon
Tel: 04 78 17 50 50
Mercure Lyon - Center Brotteaux Hotel
112 - 114 Boulevard des Belges, 69006 Lyon
Tel: 04 78 24 44 68
Hotel Congress
Commandant River Square,
69100 Villeurbanne
Tel: 04 72 69 16 16