Qualifications

 Qualifications of facilities and equipment
 Qualification of process machinery

• Reactors and storage tanks.
• Mixing equipment.
• Dosage and packaging equipment.
• Drying equipment.
• Compression and coating equipment.
• Secondary packaging equipment.

 Qualification of facilities installation

• System of pure waters (purified water and water for injection), according to Ph. Eur.
• Clean-in-Place Systems (CIP).
• Sterilization in Place Systems (SIP).
• Compressed air.
• Vacuum tool.
• Nitrogen, etc ...

 The service is adaptable to your needs depending on the particular situation of each equipment or installation and consists of:

DQ Phase

For equipment and new facilities, we verify at design level the accomplishment of the defined requirements of the user and the compliance of the applicable regulations in each case.

IQ Phase

After implanting, we check the proper installation, status, location, instrumentation, services, documentation, etc.

OQ Phase

Verification of the proper working of the equipment, according to the functional specifications expected. In the case of fluids, verification of the quality of each one of them in the usage point.

PQ Phase

• For the equipment: verification of the working order with product depending on the different processing formats.
• For service facilities: verification of quality maintenance in the usage points during a long time period.

METHODOLOGY

• Writing a qualifying protocol to sign before starting work • Execution of checks described in the protocol • Analysis of results and evaluation of deviations • Writing a staff report.

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