Challenges in qualification / validation in an industrial pharma or MD environment

Articles Medical Devices Pharma & Biotech Qualification / Validation

The healthcare industry is constantly faced with product quality, hygiene, environmental and safety issues, as well as regulatory issues and business risks. Alispharm works with its clients to help them secure their industrial environment, from the design phase to the marketing of their products.

The Qualification/Validation process takes on its full meaning in this industrial environment control perspective. Our Q/V engineers work with our clients to help them proactively meet the regulatory requirements in force by securing and controlling all production processes and materials in order to guarantee the quality and hygiene of the products and the company’s performance.

Qualification processes

In order to ensure the conformity of all the equipment used by our industrialists, our Q/V experts intervene on Qualification processes. Equipment such as packaging lines, tablet presses or even all laboratory equipment such as BacSpot Reader, incubators or climatic chambers are qualified. Our engineers ensure the proper installation of each piece of equipment (Installation Qualification) and the concordance of the results/products obtained with the specifications predefined in the URS and the Specifications (Operational Qualification / Performance Qualification). The premises, distribution networks and air treatment systems associated with each piece of equipment will also be monitored in this Qualification process.


In parallel, our experts also work in Validation in order to secure and control all the production processes and methods used, always with the objective of guaranteeing the quality of the products and results. Thus, each manufacturing process (e.g. drying process, compression process), packaging, cleaning and storage process will be deployed to control their conformity. Computerized systems are also monitored as part of this Validation process.

Alispharm offers its services from the elaboration of the Qualification/Validation strategy and by proposing the drafting of risk analyses, test protocols and thus the deployment of the strategy, the execution of the tests and the analysis of the results.
As Qualification/Validation is an integral part of the Quality process of our industrialists, Alispharm ensures that it accompanies them with rigor in order to best respond to the challenges and problems of the industrial health environment.

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