The success (or the failure) of a project begins in its early stages..

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

  • Deliver a GMP pharmaceutical facility respecting the budget and the deadlines
  • Achieve high performance standards in the production processes to guarantee high quality products
  • Certify the plant quality meeting the regulatory requirements (AIFA, EMA, FDA, etc.) and those of the Business

To meet those goals is necessary to:

  • Design, build and deliver a functional plant including work environments, support systems, production systems, control and automation systems, all capable of operating as expected to meet the business goals such as: production capacity, yield, efficiency, and reliability.
  • All this must comply with all the building governing rules while maintaining high level competitiveness.

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:

  • Building capacity of the lot
  • Access viability to the lot
  • Easements that insist on ownership: freeway spaces, airport restrictions, crossings of public utilities (methane pipelines, oil pipelines, power lines, etc.)
  • Public utilities availability
  • Environmental and landscape constraints
  • Fire prevention requirements
  • Energy requirements
  • Sanitary hygiene requirements
  • Existing uncontrolled building
  • Existing pollution and consequent remediation needs
  • Seismic requirements
  • Areas needed for operational functions
  • Areas necessary for the warehouses and their interconnection with the
  • Viability outside the building
  • Areas and volumes needed for technical services
  • Areas for waste management+
  • Availability of internal utilities (for extensions of existing structures)

Great attention must be paid to assess how the individual constraints affect each other often compromising the feasibility of the work. Some examples:

  • hydrogeological constraints impact on rainwater disposal systems by requiring
  • lamination tanks that impact on the space available and on the budget
  • the quality of the electricity supply impacts the need for generators that require space and generate acoustic impact
  • fire prevention constraints affect the feasibility and costs of intensive warehouses and related design and construction methods

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.

In the next article you will find out where unnecessary costs origin during the building process of a GMP pharmaceutical facility

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.

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