Question about what FDA looks for in equipment validation

[AB1957]

Hello,

This is my first time using Elsmar, I hope I'm in the right section.

I'm trying to validate a piece of custom equipment used to manufacture a drug regulated by the FDA. One critical parameter is the process speed, which is controlled by a motor, gears, encoder, motor controller, firmware, etc.

Question: Can I treat the entire system as a black box, ignore its inner workings, and demonstrate with test data that the equipment is capable of a consistent process speed that makes a consistent drug that is safe and effective for the patient? Or does the FDA care about the inner workings of this black box, thereby requiring me to document what motor, gears, etc are inside the system?

These are the 2 opposing viewpoints in the company I work for, and I would like to learn which viewpoint is the correct one for the FDA. Thanks in advance.

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[QAengineer13]

Hello,

This is my first time using Elsmar, I hope I'm in the right section.

I'm trying to validate a piece of custom equipment used to manufacture a drug regulated by the FDA. One critical parameter is the process speed, which is controlled by a motor, gears, encoder, motor controller, firmware, etc.

Question: Can I treat the entire system as a black box, ignore its inner workings, and demonstrate with test data that the equipment is capable of a consistent process speed that makes a consistent drug that is safe and effective for the patient? Or does the FDA care about the inner workings of this black box, thereby requiring me to document what motor, gears, etc are inside the system?

These are the 2 opposing viewpoints in the company I work for, and I would like to learn which viewpoint is the correct one for the FDA. Thanks in advance.

Equipment Qualification is vital part of validation, the new FDA process validation guidelines has changed expectation for equipment qualification. I would recommend you document the DQ (Design Qualification) from your custom equipment manufacturer , also the EQ (Equipment Qualification) which includes your IQ, OQ , PQ. Also nclude your Site Acceptance test (SAT) or FAT (Factory Acceptance Test).

I'm afraid that you cannot treat your system as a black box and ignore its inner working parts, you need to have documentation reference ( Ex. DQ) from your contract manufacturer and then your IQ, OQ , PQ, FAT/ SAT. All qualification activities and testing based on risk analysis, (Ref: ASTM E2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment)

Needless to say ....Documentation is vital: Consistency, technical content , GDP and document retrieval ,Hope this helps!

 

[v9991]

I agree with QAengineer13, for a custom build equipment, we ought to go through complete set of validation processes; having said that, we can Potentially-scope-out the extent of validation on user-side appropriately.

here;s few quick references, just in case...
Qualification / Validation Quality Risk Assessment in the Pharmaceutical Industry

Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations

Volume II - Equipment ORA-LAB.5.5

Facilities & Equipment: CGMP Requirements

6 Steps to Compliant Equipment Qualification

Equipment Qualification toolkit