FROM THE DEVELOPMENT OF THE FIRST TRANSITION AND FLOW DIAGRAM, TO NEW PHARMACEUTICAL DEPARTMENT VALIDATION, CAN PASS UP TO 2 AND A HALF YEARS DURING WHICH MANY ISSUES CAN EMERGE.
AMONG THESE DANGERS, THE MOST INSIDIOUS CAN CREEP IN THE EARLY STAGES OF THE PROJECT.
LET’S SEE WHICH ARE THE MAIN DIFFICULTIES AND HOW THE PM CAN INTERCEPT THEM AND MOVE BEFORE THEY CAUSE HUGE DAMAGE.
The goals for the PM in a GMP pharmaceutical plant
To meet those goals is necessary to:
WHERE THE THREATS TO THE PM’s GOALS HIDE?
The most subtle and potentially dangerous threats for the building’s budget and deadlines, don’t depends on technological aspects but they origin from engineering authorization processes.
Perhaps just few PMs in the life science sector ever considered the existence of a discipline called “authorization engineering”, and yet this phase of the process is the most delicate and uncertain because the interlocutors are external to the implementation process and very often their bureaucratic approach slows down the decision-making process and strongly affects the time and costs of the work.
Let’s see which are the aspects, generally involved, that must be considered and evaluated during the authorization engineering phase:
Great attention must be paid to assess how the individual constraints affect each other often compromising the feasibility of the work. Some examples:
Authorization engineering has a strong impact on the business plan.
The PM cannot afford to miss the deadlines and budget limitation of the business plan
For these reasons the Project Manager must face the authorization engineering from the very beginning
Only in this way the PM will not run the risk to modify deadlines and budget after the BOD has allocated the budget, planned the business, launched the institutional communication, etc.
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 many more.