Recent questions on a webinar on Verification and Validation:

My responses:

 

Ques 1: 

In the handouts the term “pre-approval” is mentioned several times. Going through the recording did not fully make this term clear to me. Would be great to have some details on what´s behind this.

Ans 1:  I use the term when I add to a validation test report a pre-approval signature block.  The document is routed to the stakeholders for review and approval before the validation is run, to get changes and "buy-in" to the format and test cases beforehand.  It reduces the problems of getting post-approvals when the signatories didn't have a chance to agree to and sign off on the proposed validation prior to performing it. Your validation SOP would be written to address this feature if you chose to employ it. 

 

Ques 2: 

I would like your assistance with a question raised during a discussion regarding manufacturing process verification/validation:

In one of the implant’s identified critical processes, a visual inspection (under microscope by a technician) is one of the tools used to validate the process.

 The question we are facing is whether the visual inspection should be in a quantitative scale rather than qualitative.

Please bear in mind that the visual inspection is done by a technician who uses specific criteria for approval/disapproval of the implant.

 

Ans 2:  Quantitative is generally better that qualitative, as subjectivity / interpretation elements are greatly reduced.  But qualitative inspections are used frequently.  How you structure the visual inspection to reduce subjectivity / interpretation would be a key consideration.  One can also be used to complement the other for some inspection elements. And monitoring the results over time will provide the best indication of the effectiveness of a chosen approach, a CGMP requirement anyway.

- jel@jelincoln.com

Definition added 08/30/23:  Qualitative observation results cannot be measured while quantitative observation gives measurable data. Quantities like area, height, weight, temperature, weight, time, speed, etc., are examples of quantitative observation while smell, taste, texture, color, etc., are examples of qualitative observation.

Years ago, on specs on/in injection-molded plastic parts, we changed a qualitative "test" (a subjective "too many") to quantitative (mostly; an unacceptable volume to total black specs per set area per the chart) by implementing the use of a TAPPI Dirt Chart, with a pass/fail range.  See:

https://www.tappi.org/publications-standards/standards-methods/charts--datase/

- JEL 09/19/2023 

Additional justification for "pre-approval": 

 

FDA's Guidance:  "Analytical Procedures and Methods Validation for Drugs and Biologics", issued July 2015, beginning at line 264: 

     "Validation data must be generated under a protocol approved by the sponsor following current   

     good manufacturing practices with the description of methodology of each validation characteristic       and predetermined and justified acceptance criteria, using qualified instrumentation."

-- color added, similar statements can be found in other such documents.  E.g., Google "What is pre-execution approval of validation test scripts?"  -  JEL 10/13/2023