Validation of Facility Utilities

• The validation of the utilities was carried out through the drafting and execution of appropriate performance qualification protocols involving chemical and/or microbiological analysis of the most critical points of use.

This criticality was supported by a preliminary risk analysis process in accordance with directive ICH Q9 Quality Risk Management – November 2005.

The choice of points to be monitored (whether new or existing) was then justified and based on the analytical results it was possible to predict a periodic monitoring plan guaranteeing the quality of the points of use in accordance with current regulations and the customer’s internal specifications.

This activity required a considerable commitment and specific expertise from a
technical, documentary, and regulatorypoint of view. For this reason, the client turned to an external service provider.

On the basis of the reference legislation (Official Pharmacopoeia, GxP, Edralex) and internal procedures, the work team analysed the requirements envisaged by the project and prepared a Risk Analysis document in accordance with the FMEA methodology to establish points-of-use criticality.

Once the points of use with a medium/high criticality level (i.e. with a significant risk of contamination of the product or materials) were identified, it was possible to choose which ones to sample and therefore which ones to submit to the chemical/microbiological analyses provided for in the validation protocol.

At the end of the qualification phase for the points of use, a Periodic Monitoring Plan was developed, in which, through a further Risk Analysis process, the points of use to be included in the routine sampling (periodic analyses) were defined.

The project included the installation of both new points of use and modifications to existing points of use; the planned activities originated from several existing projects including: construction of a new laboratory, construction of a new granulation area, and revamping of pre-existing areas.

The complexity of projects related to utility validation activities has required several months of work and continuous collaboration with the various departments of the client company, including the Quality, the Validation, the Production and, the Engineering departments and the chemical and microbiological Laboratories; the need to interface with the company’s different operational areas has highlighted S4BT’s ability to adapt to any context and to establish fruitful cooperation with all work teams