For the successful execution of qualification and validation a special knowledge and experiences regarding machines technology, pharmaceutical processes with their influences and the pharmaceutical regulations is necessary.

In order to gain understanding for the process and the requirements of validation at this interface, the following services are specified:

• Consultancy for planning and performing the Validation of manufacturing equipment.
• Support for management and execution of Qualification and Validation activities.
• Assistance for FDA Audits regarding Isolator topics.

Other services complete this consultancy and support activities:

• Preparation of Qualification documents e.g. Standard Operation Procedures (SOP), Risk analysis (RA). Review of Calibration certificates and Qualification plans for DQ, IQ, OQ, PQ.
• Optimization of measuring devices applications during execution and planning of Qualification and Validation. 

Many pharmaceutical companies have a dedicated department for Qualification and Validation of their equipment, which will later on execute the Revalidation of the processes.

 

To perform the initial Qualification of new equipment by one’s own qualification department is advantageous to collect experiences and get a better understanding of how it works. This has as well a benefit for representing the Validation results against the authorities, especially when the document formats are according to the corporate identity.

 

Measuring instruments for the execution of the qualification activities are usually present, may be some special equipment must be organized.