GMP and Conceptual Design? More @ Sophidis Days

Sophidis Days, an important event for the Pharmaceutical sector in Maghreb, will take place on the 12th and 13th of October. The technical director of RC REDOL, Ana Gonçalves, will speak at the event, discussing all aspects of Good Manufacturing Practices (GMP). One of the approached points will certainly be the Conceptual Design.

Sometimes overlooked, Conceptual Design is a fundamental step in having compliant facilities suitable for the operations that will be conducted. Without a proper Conceptual Design, any subsequent stage of the facility may be subject to changes and adaptation, which have not been thoroughly studied at the beginning and will therefore bring non-optimal solutions, which will be costly to the budget.

With the preliminary study and definition of the initial requirements of spaces, installations, process equipment and auxiliary systems needed, Conceptual Design will involve all aspects of pharmaceutical production. However, its main objective is to define the specifications of the facilities in order to meet the main GMP requirements of the products to be manufactured, as well as local and international standards.

That is why the results of this process are normally linked to the type of production to be developed and the corresponding definition of the size and capacity of the facility, the dimensioning of the production schedule, based on a sales forecast, but also the identification and dimensioning of the main equipment and utilities, taking into account the estimated investment budget. Essentially, in any new facility or facility renovation project, there must be an extra effort to gather all the necessary elements, so that decisions can be made on the course of action to take. These are all parts of good planning, vital to avoid unnecessary complications downstream.

RC REDOL has the human resources and experience to make these processes fruitful, and guarantees the guidance in Conceptual Design you need when developing new pharmaceutical production facilities. If you are involved in one of these processes or if you are looking for a restructuring of your facilities, contact us. We guarantee you will find the most suitable way to achieve your goals.

RC REDOL, building connections!