Home » The challenges of the new Annex 1 to the PM of the Pharmaceutical Industry

The challenges of the new Annex 1 to the PM of the Pharmaceutical Industry

The pharmaceutical sector is highly regulated and only 'zero risk' is allowed; in this context, ANNEX1 is the bible. Zero risk' also comes through the design of the pharmaceutical infrastructure, and through IQ-OQ-PQ and Area Validation it is realised in the drug.
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The successful project manager in the pharmaceutical sector must truly be the main hub of integration, able to bring together a complex array of equipment and solution providers, pharmaceutical engineering companies, manufacturers and validators.
Limited budgets, tight schedules and project team dynamics are challenges that can stifle innovation, reduce success to the point of threatening the outcome of AIFA GMP inspection and authorisation.

Changing regulatory and marketing realities can impose changing scope and expectations for GMP facilities, both in design and construction. Changes in project scope and redirections are inevitable and often essential to achieve strategic business objectives.

One of the keys to success in managing complex projects in the pharmaceutical industry, but not only, is to adopt organisational schemes that allow an often fluid objective to be achieved under equally fluid operating conditions.

The incorporation of these innovative schemes, for the entire process of implementing a GMP plant, must include the use of new paradigms of project team organisation.

Innovative contracts, such as truly transparent Open Book formulas as an alternative to the usual EPCMs (https://www.politesi.polimi.it/handle/10589/107578) and innovative design tools such as BIM (https://it.wikipedia.org/wiki/Building_Information_Modeling), can offer great advantages in the pharmaceutical sector, allowing new facilities to be built faster, with a better response to cost and quality requirements, easier to manage in compliance with GMP, and ultimately shortening the time for IQ-OQ-PQ and AREA VALIDATION, with a guarantee of successful AIFA GMP inspection and authorisation.

The realisation of one of the first GMP facilities in Italy designed with the BIM process …. if you want to know more…

The project manager in the pharmaceutical sector, engaged in the planning and delivery of the ‘pharmaceutical factory of the future‘ can now rely on solid support, provided by modern design and project management tools, as well as an increasingly sophisticated equipment and systems supply network.

The integration of the many sections of a pharmaceutical project, all of which are highly complex, dynamic and interactive, is essential and is a highly sought-after and valuable capability and differentiator that organisations consider when selecting PMs, their professional partners and pharmaceutical engineering companies to deliver capital-intensive GMP facility projects.


  • What could happen if, when you have to introduce process equipment into your new pharmaceutical plant, you realise that the pistons of the freeze-dryers do not fit and interfere with the attic.
  • Or if at the time of applying for agibility you were not issued with a Fire Prevention Certificate due to a lack of mandatory requirements.
  • And what if only when introducing autoclaves weighing a few tonnes did someone realise that the floors would not support the load?
  • And what if someone only realised during excavation that there is an easement generated by a public utility’s medium voltage line, underground, running through the site, which cannot be changed until six months from now?
  • What would be the consequences of a six-month delay?
  • How much would the contractors’ demands cost you?
  • What are the damages on your company’s business plan for not producing on time?
  • And what would be the cost to your company and your credibility if the new facility incurred frequent GMP nonconformities due to inadequate facilities?

The project manager in the pharmaceutical sector, in addition to the challenges of the new ANNEX 1, also has the same objectives as those in other sectors:

  • Respect time;
  • Respect the budget;
  • Achieve the required performance;
  • Achieve the expected quality.

Pharmaceutical engineering hides many more pitfalls than others, for one simple reason: the building, its finishes and its equipment are an integral part of the process: they are substantial and fundamental elements for production, so much so that pharmaceutical finishes, HVAC systems for classified areas, CFR 21 Part 11 control systems and Clean Utilities can certainly be considered true process equipment.

This requires special and general organisational tools and skills, which are transversal to the entire project TEAM:

  • knowledge of the GMP set out in ANNEX1 is essential but not sufficient;
  • you must know the authorisation processes to be followed in order to obtain the building permit and then the fitness for use of the new pharmaceutical infrastructure;
  • you need to know the regulatory aspects of AIFA, EMA, FDA;
  • you need to know the rules governing procurement;
  • what must the Safety Coordinator during Execution (CSE) do on a pharmaceutical building site?
  • what are the pitfalls of fire prevention for a pharmaceutical plant?
    how is it best to structure contracts?
  • what are the contractual conditions with which to bind contractors?
  • how to control time, costs, quality of work?
  • how to manage delays and contingencies?
  • how can disputes be avoided by dosing the ‘carrot and stick’ wisely?

The PM in the pharmaceutical sector must be familiar with these tools, implement them and select TEAM members who, in addition to having the necessary technical skills, fully share the objectives and tools.

The author is a founding partner in 2002 of the engineering company Planex S.r.L. and has been involved in the engineering of pharmaceutical plants and buildings for over 30 years, starting in 1989 with the design and site activities for a new department of lyophilised injectables for the company Lepetit, which at the time belonged to the DOW Chemical group, up to the present where he is managing the design and construction of the new production site M. Polo production site of the Zambon Group, the Site Master Plan of an ITALFARMACO S.p.A plant, the construction of a new production department of Fresenjus Kabi S.p.A, various interventions within the EVOTEC Aptuit research centre in Verona.

In the course of his career, he has also worked on other types of extremely complex buildings. He was responsible for the construction of the production site of Pastificio Rana S.p.A. in San Giovanni Lupatoto in Verona, the Cetacean pavilion of the Acquario di Genova, the testing of the Isozaki Allianz tower in Milan, and much more.

Filippo Belviglieri
Ing. Filippo Belviglieri