Qualification vs Validation

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

Hi to all! just want to confirm to everybody what is the right term if i’m talking about equipment.
Is it to validate or qualify?

2

we validate the process and we qualify the equipment

3

My two cents on this.

You don’t validate the process or the equipment per se. The equipment is qualified then so is the process. Validation is the whole life cycle which equipment and processes go through. There are three stages that make up the validation life cycle as per the 2011 guidance:

• Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

• Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

Any thoughts?

4

We validate the process production, validate analytical method and validate cleaning of equipment.

For equipment, we do qualification (DQ, IQ, OQ and PQ).

You can read more clearly between validation, qualification and calibration in USP 32 <1058> ANALYTICAL INSTRUMENT QUALIFICATION

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