QUALIFICATION

Equipment qualification

What is it?
A set of actions performed to attest and document that any facilities, systems, and equipment are properly installed and/or function correctly leading to the expected results.

Qualifications apply to all equipment, facilities, and utilities that have direct impact on product quality. In the case of new equipment and/or utilities, it is required before starting its use.

For equipment/utilities with indirect or no impact related to the Good Practices, only commissioning may be carried out.

When a piece of equipment or utility has computerized systems and/or interfaces with these, CSV activities may be handled as part of a qualification or as a specific project.

Qualification must be performed for productive, laboratory, utility, and other applicable equipment.

What are the types?
• Prospective
• Concurrent

Why qualify?
• Compliance
• Safety
• Efficacy
• Quality

What are the types?
• New Equipment
• Equipment in use
• Changes in equipment

Thermal Qualification

What is it?
It is conducted to attest and document that thermal and refrigerated equipment are operating within the expected temperature range and that it is homogeneous, assuring safety and quality for stored products.

Thermal qualification is part of equipment Operational and Performance Qualification. In Operational Qualification, it is usually verified the performance of the empty equipment, while in Performance Qualification, loading tests, door opening, and power failure tests are carried out.

Which equipment are used?
• Validators
• Recorders
• Data loggers

Why qualify?
• Compliance
• Safety
• Efficacy
• Quality

When qualify?
• New equipment
• Changes in cycles and temperatures used
• Following critical changes
• Periodic requalification

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