The development stages of engineering project in the Pharmaceutical industry

As we saw in the first article the “Annex 1” draft, by introducing the obligation to provide a contamination control strategy, makes extremely important the design phase of the new pharmaceutical plant (or the components in direct contact with drug production).
This article will illustrate which are the main phases required in the project of a “pharmaceutical factory”

The manufacture of pharmaceutical products must take place under the GMP (Good Manufacturing Practices) procedures and the design, or better the engineering process behind a pharmaceutical plant or a single department, can be defined as the process to be adopted to develop an “intentional functionality” for a demanding set of operational requirements.

Engineering for the pharmaceutical industry includes the design and construction of structures intended for special purposes that operates in GMP’s and involves permitting engineering, structural and plant engineering in addition to other disciplines necessary to conceive and document the necessary technological solutions to obtain specific functional requirements.

The Project Manager of the pharmaceutical industry is the person responsible to choose the company assigned to design the new GMP pharmaceutical facility, to validate the structure and the procedures, and to draw a management and maintenance plan.

The engineering process must begin with a risk analysis (QRM – Quality Risk Management according to the ANNEX1 draft) extended to all spheres of influence that can impact on the construction of the GMP facility:

Authorization processes: building permits, fire prevention, environmental authorizations, etc.
Regulatory processes: GMP (dictated by AIFA and the new ANNEX1 – Draft).
Business continuity: processing impacts on internal roads, Utilities (Black / Pharma / FEM), regular production (vibrations, material logistics, people flows).
Procurement strategies: impact of different possible procurement structures on the construction process, costs and final performance.
Social: impact on employees services such as canteen, car parks, refreshment areas, etc.
Environmental: it’s essential to demonstrate the building environmental sustainability to protect the image of the pharmaceutical company. It is therefore advisable to evaluate the possibility, and the additional costs, to obtain an environmental sustainability certification

Many companies, including pharmaceutical ones as Pfizer, Bristol Myers Squibb, ISPE, have already adopted the LEED® protocol (for more information about the protocol: https://www.greeninglab.it/faq-protocollo-leed/

Economic Financial: Industry 4.0 preassessment, Cash Flow analysis, ROI analysis.

Then it is possible to proceed with the development of the remaining engineering phases:

Basic design
Permitting design
Detailed design

The technical drawings and specifications are initially necessary to select and direct the contractors, later they can direct commissioning and validation processes besides the building and maintenance operations.

In fact the pharmaceutical production is heavily conditioned by the HVAC plants, the internal partitions, such as walls and ceilings, the control systems and finally the starting, balancing and calibration procedures.

These reasons require that a PM of a GMP pharmaceutical project controls, more than any other sector, all the critical aspects that can wreck the project and undermine its goals.

A PM in pharmaceutical industry necessarily has to rely on a pharmaceutical engineering company that operates according to Good Engineering Practices (or GEP).

Only in this way the PM can concentrate on the research of innovative solutions that can predispose the project for future and frequent changes in its purpose, not only in the course of its life but also during the design and construction phase.

This article is for those who have to manage the construction of a new pharmaceutical department.
The PM must know the needs very well in order to must manage the pharmaceutical engineering company in charge.
The PM also has to manage his own internal team.
Must choose plant construction companies.
And finally must supervise the start-up, commissioning and validation phases; making sure that there are no hitches or errors that can compromise the final expected results.

CHECK POINT N.1
The project team MUST have an Engineering Project Manager with experience in GMP facilities engineering !

Our next article will present you the checklist containing the 28 key conditions, which you must include into the specifications for the assignments of the engineering company in charge of your successful 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 much more.