Facility and Equipment Qualification

Facility, utilities and equipment qualification includes all the actions that provide that equipment, environments, machines, systems and instrumentation are properly installed, work correctly, and lead to the expected results. General principles on Qualification, which is part of validation, are outlined in different important regulatory references and guidelines, as for example the EU-GMP Annex 15 or US FDA (FDA Guidance for industry, 2011). Annex 15 of EU-GMP states that “qualification activities should consider all stages from initial development of the user requirements specification through to the end of use of the equipment, facility, utility or system”. Depending on the complexity of the project, the main stages are represented in the V-diagram below:

All qualification steps are accompanied by approved documentation and authorized by appropriate personnel as defined in the pharmaceutical quality. Qualification protocols define the critical attributes and parameters to monitor and control and their acceptance criteria based on the criticality of systems. Indeed, quality risk management principles, introduced by ICHQ9 guide line, are applied also to qualification activities and the risk assessment exercise, supporting qualification, should be repeated as required by the increase of knowledge and understanding from any changes during the project phase or during commercial production.

There are many reasons why qualification is an important stage of pharmaceutical production. Besides being a regulatory requirement, facility and equipment qualification gives confidence that the equipment is capable of operating correctly within established limits and tolerances. This means assuring the quality and safety of a pharmaceutical product, whether bulk or finished product, whether sterile or not. Moreover, qualification stage assures consistent production performance, by identifying and correcting problems that may occur during routine production and therefore reducing production time and costs, downtimes and the number of maintenance operations.

• IQ, OQ, PQ protocols
• Environmental qualification
• Support for defining the risk-based strategy
• Critical review of qualification documents