New ANNEX 1 challenges for project managers in the pharmaceutical industry

This article begins a series dedicated to a very important industrial sector in Italy, the pharmaceutical industry.
The pharmaceutical sector is strongly regulated, and the drug production permits only “Zero risks“.
In this minefield the “
ANNEX 1” represents the Bible.

The “Zero risks” target necessarily passes from the pharmaceutical infrastructure project and, through the IQ – OQ – PQ processes and the area validation, gets to the drugs production.

The next articles are specifically aimed to the project managers working in this industrial sector.

THE DRUGS’ PRODUCTION BEGINS FROM HERE

IT GOES BY ONE CRANE

A MEP / PHARMA BUILDING SITE

A CLEAN UTILITIES BUILDING SITE

TO ARRIVE AT INFRASTRUCTURE VALIDATION 

In the pharmaceutical industry, a successful project manager must be the real cornerstone of the entire project that can coordinate the various professionals involved such as the equipment providers, the pharmaceutical engineering companies, the manufacturers and the validators.

Limited budgets, tight deadlines and misunderstanding in project team 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. Project scope changes and redirects are inevitable and often essential to achieving strategic business goals.

One of the keys to success for the management of complex projects in the pharmaceutical field, but not only, is to adopt organizational schemes that allow to achieve at the same time a goal, often fluid, in equally fluid operating conditions.

The integration of these innovative schemes within the entire building process of a GMP plant, must include new organizational paradigms for the project team.

Innovative and transparent contracts, such as Open Book formulas, alternatively to the usual EPCMs  (https://www.politesi.polimi.it/handle/10589/107578) and innovative design tools, such as BIM design (ht.wikipedia.org /wiki/ Building_Information_Modeling), can offer tremendous benefits in the pharmaceutical industry!

These solutions can permit new facilities to be built more quickly, with a better response to cost and quality requirements, easier to manage in compliance with the GMPs, and finally shortening the time required for IQ -OQ-PQ’s process and AREA VALIDATION, guarantying a successfully AIFA GMP’s inspection and authorization.

If you want to know more about the design of one of the first italian GMP Plant with the BIM process

The Project Manager in the pharmaceutical sector, engaged in the planning and delivery of the “pharmaceutical factory of the future” can now count on solid support, provided by modern design and project management tools, as well as on a supply network of equipment and systems always more sophisticated.

The organizations consider the capacity of integrating the numerous sections of a pharmaceutical project, all extremely complex, dynamic and interactive, one of the most valuable and qualifying skills when selecting PMs, their professional partners and pharmaceutical engineering company for the construction of capital-intensive GMP facility projects.

THREATS ARE ALWAYS AROUND THE CORNER…

I can imagine how you might feel if, when it comes to introduce the equipment into the new pharmaceutical plant, you realize that the pistons of the freeze dryers don’t fit the available height of the internal spaces.

Or again, when it comes time to request for building accessibility the Fore Prevention Certificate is not available due to lack of mandatory requirements.

What if someone realizes that the floors do not hold the load of the autoclaves only at the time of introducing them?

What if someone notices only during the excavations that there is an easement generated by an underground public utility medium voltage line that crosses the site and which cannot be changed for six months from now?

What would be the consequences of a six months delay?

How much would the requests from contractors cost to you?

Which would be the consequences on your company’s business plan associated with the postponement of the production compared to the terms granted?

And what are the costs for your company and your credibility if the new plant frequently do not comply with the GMP standards due to inadequate solutions?

The Project Manager in the pharmaceutical sector, in addition to the challenges associated with the new ANNEX 1, also has to respect general requirements as:
• Respecting deadlines;
• Respecting the economical budget;
• Achievement of expected performance level;
• Achievement of expected quality.

Pharmaceutical engineering results more insidious than other sectors, for one simple reason: the building, its finishes and its systems are integral part of the whole productive process. The pharmaceutical finishes and the HVAC systems used for the classified areas, the CFR 21 part 11 control systems and the Clean Utilities, are elements so substantial and fundamental for the production that can certainly be considered real process plants.

For this reason, the project team needs to develop general and particular organizational tools and skills, which must be cross-cutting across the different figures involved:
• The knowledge of the GMPs indicated in ANNEX1 is essential but not enough;
• You must know the authorization processes to follow to obtain the building permit and then the usability of the new Pharmaceutical infrastructure;
• You must know the regulatory aspects of AIFA, EMA, FDA;
• You must know the rules governing procurements;
• What should the Safety Coordinator do in a pharmaceutical site during the Construction Executive Phase (CSE)?
• What are the treats involved in the pharmaceutical plant for fire prevention?
• Which is the best way to organize the procurements?
• Which are the best contractual conditions to bind the contractors?
• What’s the best way to control deadlines, budgets and high quality of work?
• How to manage delays and unforeseen events?
• How to avoid disputes by wisely dosing “carrot and stick”?

The PM in the pharmaceutical sector must know these tools, implement them and select the members of the TEAM who, in addition to having the necessary technical skills, must share the project’s goals and tools.

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.

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