Brazilian Academy of Pharmacy, Gonzalez Tablas, Barcelona, Spain
1. A PROJECT IS AN UNCERTAIN UNDERTAKING
”Pharmaceutical project” is the practical denomination given to the process of designing, constructing or reforming, and starting pharmaceutical manufacturing facilities. Projects, both involving biotechnology and traditional products, are abundant all around the world. Their motivations can be very varied: local manufacturing of imported products, winning new markets, launching new products, coping with increased demands, etc. Big world-wide companies are usually well prepared and have experience in managing projects anywhere, but for other smaller organizations a project is a true ”tour de force”, as most of their technicians have experience in manufacturing but not in handling projects.
In a project there are many variables to be taken into account (requirements, information, communication between intervening parts, traceability, training, documentation, management, etc.) and this is why its success is far from being assured beforehand. It is true that in most of cases manufacturing can start, but often with unbearable delays and without attaining the expected results.
2. THE MANY DYSFUNCTIONS OF A PROJECT
A project is basically the result of the interaction of two parts: On one side, the pharmaceutical organization (contract giver) and on the other the supplier (contract accepter). There are in fact many suppliers but they are usually coordinated by a single one which acts as the counterpart of the laboratory, but even within this simplified frame there can be (and in fact, there are) many hazards (see Figure 1). Let’s mention some of them:
(a) ”Unclear objectives” on the side of the pharmaceutical laboratory. This might seem surprising, but it is quite common because it is a consequence of wishing to have a kind of “flexible laboratory capable of reacting to different needs”. Experience shows that this can seldom be attained and that the result is usually unsatisfactory.
(b) Inadequate selection/follow-up of the supplier can also led to unpleasant surprises.
(c) The supplier receives inaccurate information on the project because the document of URS (User requirements specification) does not exist or is not well prepared.
(d) Personnel obstructionism cannot be discarded. Human beings tend to react negatively to changes and this is why a new project can face, consciously or unconsciously, important resistance.
(e) Implementing a project far away from the head-office of a company is often risky. Senior managers have to travel to the manufacturing site. Good local work-force is not always available.
(f) Inadequate design or study of the project on the side of the supplier can lead to failures or delays.
(g) Sometimes the starting point of a project is a development laboratory and it is well-known that the “souls” of development and manufacture are quite different. It is not without reason that GMPs are not required in the development stage. Thus, the question might be: is the production project enough “mature” to be put into practical manufacturing? Are well understood the commercial manufacturing requirements?
(h) In international projects differences in mentality and misunderstandings derived of insufficient knowledge of the language can take their toll.
(i) The supplier has prepared the necessary documentation for developing its project, but will the laboratory receive the necessary information for qualification and start-up?
(j) As already said before, the active participation of personnel is far from being guaranteed.
(k) Even with the best and state-of the art facilities success will only be assured if there is adequate management and adequately trained personnel.
Figure 1: Main hazards in the phases of a project.
Furthermore, the conclusion of the construction of a project does not ensure that manufacturing will be started successfully:
3. PREVENTIVE ACTIONS TO ENSURE THE SUCCESS OF A PROJECT
Thus, it can be said that the success of a project depends on the following twelve commandments:
1st Define clearly objectives and expectations in a URS document.
2nd In case of doubt before starting a project perform tentative pilot studies (e.g. in a university or research center).
3rd Select reliable suppliers.
4th Choose motivated people (remember that changes will hardly be implemented by those who are affected by these same changes).
5th Evaluate carefully pros and cons when selecting the location of a project.
6th Ensure that suppliers have understood the requirements.
7th Make sure that the project is scientifically sound and meets URS.
8th Guarantee good communication and understanding among all the intervening parts.
9th Ensure traceability and change control at all times.
10th Make certain that the suppliers will timely provide the laboratory with the necessary documentation.
11th Ensure there is adequate management and that the direction is involved in the project.
12th Provide adequate training.