MOST OF THE GMP PHARMACEUTICAL MANUFACTURING FACILITIES ARE COMPLEX AND EXPENSIVE, AS ARE THE PROJECTS INVOLVED IN THEIR IMPLEMENTATION.
ALL THE TECHNICAL PROFESSIONALS INVOLVED IN THESE PROJECTS ARE EXPECTED TO SUPPORT THEIR ORGANIZATIONS IN PROVIDING SOLUTIONS THAT MEET THE CURRENT BUSINESS EXPECTATIONS AND STANDARDS, ADAPTING THEM TO PROBABLE DYNAMIC CHANGES.
HOW TO FACE AND WIN THESE CHALLENGES?
THE RECOMMENDATIONS IN THIS GUIDE COME FROM MY 35 YEARS EXPERIENCE IN THE MANAGEMENT OF COMPLEX PHARMACEUTICAL PROJECTS.
A successful project manager must be the real cornerstone of the entire project that can manage the needs of the different plants and equipment, and coordinate the various professionals involved, such as the designer, the equipment providers, the builders, and the validators.
Limited budgets, ANNEX1 GMP requirements, tight deadlines and team project’s misunderstanding are some of the challenges that can stifle innovation, reduce efficiency to the point of threatening the outcome of the AIFA GMP’s inspection and final authorization.
The constant evolution in the regulation and marketing realities, can impose new scope or expectations in GMP (Good Manufacturing Practices) structures, both in design and construction phase, jeopardizing the Contamination Control Strategy which is the new key element of ANNEX1.
Project scope changes and redirects are inevitable and often essential to achieving strategic business goals.
Below you can find the most important clauses to be included in contracts to entrust engineering services for the construction of your GMP pharmaceutical facility:
1. Ask for a single EPM (Engineering Project Manager) to be identified for the whole project, from the Design phase to the Validation Assistance phase, who has at least 20 years of experience.
Additional tips: the Engineering Project Manager does not need to be a specialist in any discipline, but he must be familiar with the pharmaceutical world. So, ask him some specific questions:
• How to manage the project to respond to the Contamination Control Strategy envisaged by ANNEX1?
• How would you position the opening direction of the doors of an air-lock?
• What materials and welding processes would you use for a WFI loop?
• Which systems would you use to control the pressure gradient between different rooms?
• What pressure difference is needed between areas with different classifications?
• What is a flow and transition Diagram?
• What is ISPE?
• What is an isolator? What environmental class of Background is required for an isolator?
2. Ask for an Engineering Project Manager with experience in managing complex projects, in dynamic environments, and that master organizational methodologies (Agile or 6 sigma or similar) to manage teams composed of stakeholders within your company and the specialists of the company engineering.
3. Ask the engineering company to identify in the project team a communication manager to ensure the sharing of information within the project team and towards the client.
4. Ask for a single person responsible for the authorization engineering phase to be identified, who has at least 10 years of experience.
Additional tips: an inexperienced fire-protection specialist could led to high extra costs, due to over-precautionary solutions that could be simplified with a competent approach of FSE – Fire Safety Engineering.
5. Ask to include and identify a fire prevention specialist in the project team, who has at least 10 years of experience in industrial fire prevention projects and proven experience in Fire Safety Engineering.
6. Ask to include and identify in the project team a HVAC system engineering specialist who has at least 15 years of experience in GMP structure projects for pharmaceutical departments in controlled environmental class.
7. Ask for a CFR21 compliant data management specialist to join the project team.
8. Ask to include and identify in the project team an Electrical and Special systems specialist with at least 15 years of experience in industrial projects.
9. Ask to include and identify in the project team a specialist for pure pharmaceutical fluid systems (WFI, PS, DIW, N2, etc.) who has at least 10 years of experience in the sector.
10. Ask to include and identify in the project team an industrial architecture specialist who has at least 10 years of experience in industrial projects and at least a couple of pharmaceutical finishing projects in the GMP field.
11. Ask to include and identify in the project team an industrial structural engineer with at least 15 years of experience in industrial projects.
12. Ask to include and identify in the project team an environmental sustainability and energy specialist with at least 10 years of experience in sustainable building projects, according to international sustainability protocol (LEED, BREAM).
13. Ask to include and identify in the project team an environmental engineering specialist with at least 10 years experience in environmental engineering and management for infrastructural works.
14. Ask to include and identify in the project team a Safety Coordination specialist in the Design phase and in the Execution phase (CSP and CSE) with at least 15 years experience in industrial projects.
15. Ask to include and identify in the project team a specialist for the design and management of commissioning activities (IQ-Installation Qualification, OQ-Operational Qualification, PQ-Performance Qualification) who has at least 10 years of experience in Commissioning Process Management activities.
16. Ask to insert and identify a BIM Manager in the project team for the coordination of the pharmaceutical design process with BIM (Building Information Modeling).
The BIM design in the pharmaceutical industry still doesn’t have a competitiveness factor.
The BIM is the only design method that guarantees perfect coherence and congruence between all the components of a complex work.
BIM reduces construction times.
BIM reduces unexpected costs.
BIM allows to associate to each element all the information concerning it from the technical data sheets to the maintenance specifications.
BIM allows to associate to each element all the components in some way connected to it.
BIM is the ideal tool for the qualification of a GMP structure, from engineering design to final validation.
17. Ask to include and identify in the project team a general construction manager with at least 20 years of experience in the management of works of complex buildings.
18. Ask to include and identify in the project team a Site manager for structural works with at least 20 years experience in construction supervision of complex buildings.
19. Ask to include and identify in the project team a Site manager for architectural works with at least 10 years experience in management of architectural works for complex buildings
20. Ask to include and identify in the project team a HVAC system manager with at least 15 years experience in the HVAC system management for complex buildings.
21. Ask to include and identify in the project team an Electrical and special system manager who has at least 15 years of experience in electrical system management for complex buildings.
22. Ask to include and identify in the project team the manager of pure fluid system works with at least 10 years experience in the construction of pure fluid systems.
23. Ask how site inspections will take place, how often and what reporting tool is used.
24. Enter the obligation to manage the project with a shared Project Management platform (ASANA, JIRA ..) which can also be accessed by the Client’s internal project team.
25. Requires the Site Manager to regularly check the costs of the construction site.
26. Ask to present explanatory examples of experience in GMP projects.
27. Ask to present Examples of experience in licensing engineering.
28. Ask to present examples of experience in the field of Environment and Safety.
The author is one of the founding partners of the engineering company Planex s.r.l. since 2002 and for over 30 years, has been involved in the engineering processes of pharmaceutical plants and buildings. His career starts in 1989 with the design and construction activities for a new department of freeze-dried injectable products of the Lepetit company, which at the time belonged to the DOW Chemical group, and continues nowadays with the design and construction management of the new production site M. Polo of the Zambon Group, the site Masterplan of an ITALFARMACO S.p.A plant, the creation of a new production department of Fresenjus Kabi S.p.A., various interventions within the EVOTEC Aptuit research center in Verona.
During his career he has also worked on other type of extremely complex buildings; he has taken care of the realization of the new productive site for Pastificio Rana S.p.A. in San Giovanni Lupatoto – Verona, the new Cetacean pavilion for the Aquarium of Genoa, the testing of Isozaki Allianz tower systems in Milan and much more.