Evolving QA from 'Compliance-based' to 'Science/Risk-based' approach

Here, my general perception is that, the QA is seen/driven by largly compliance-needs(read regulatory needs!);
i.e., whenever the QA comes up with a objection/question/recommendation,
most of the times the direction of discussion is compliance-based;and more often the reasons/preferences((knowledge))/experience become the justifications for decisions.

Broadly speaking, risk/science based approach describes the 'understanding of risk/science specific to the product' ; and where required establishing the same through 'data';(of course experience, knowledge are not ignored; but emphasis lies on the data)


What are the steps you advice/implement for achieving the objective of evoving QA from 'Compliance-based' to 'Science/Risk-based' approach

If we have to start, right from the defining the procedures, what difference(s) you will bring into the procedures?

If it can be achieved by changing the attitude (of QA & other departments) then what steps would you recommend?



thanks in advance for sharing your thoughts.

v9991 said:

Here, the general perception is that, the QA is seen/driven by largly compliance-needs(read regulatory needs!);
i.e., whenever the QA comes up with a objection/question/recommendation,
most of the times the direction of discussion is compliance-based;and more often the reasons/preferences((knowledge))/experience become the justifications for decisions.

Broadly speaking, risk/science based approach describes the 'understanding of risk/science specific to the product' ; and where required establishing the same through 'data';(of course experience, knowledge are not ignored; but emphasis lies on the data)


What are the steps you advice/implement for achieving the objective of evoving QA from 'Compliance-based' to 'Science/Risk-based' approach

If we have to start, right from the defining the procedures, what difference(s) you will bring into the procedures?

If it can be achieved by changing the attitude (of QA & other departments) then what steps would you recommend?



thanks in advance for sharing your thoughts.

Click to expand...

Ans 1 -

Process Analytical Technology (PAT) is the answer to your question. The PAT guidance highlights the necessity for process understanding and opportunities for improving manufacturing efficiencies through innovation and enhanced scientific communication between manufacturers and the Agency and thereby "builds quality into the product".

Ans 2 -

This depends on what you intend to accomplish. Most companies have the PAT defined as a project and come up with different milestones.

Ans 3 -

The Guidance document on page 15 mentions the following -

"Many of the advances that have occurred, and are anticipated to occur, are bringing the development, manufacturing, quality assurance, and information/knowledge management functions so closely together that these four areas should be coordinated in an integrated manner. Therefore, upper management support for these initiatives is critical for successful implementation." and hence with out the Upper Management support, you may not accomplish the desired state.

.

PAT is surely one of the "ends/tool" to work-with;

But, in order to reach that stage; the systems/process have to be closely integrated to the approaches of ICH Q8-Q9-Q10 guidance documents;

My queries are exactly related to this point;

I get the sense that my query is too broad; but that's the situation when we have to get started in new direction, Right!?!;

Can we take some example; viz., consider example systems of "change control", ""CAPA" (Refer pg. 11,12 of ICH Q10)and try to broadly identify the implementation steps.

What are the steps you advice/implement for achieving the objective of evoving QA from 'Compliance-based' to 'Science/Risk-based' approach

If we have to start, right from the defining the procedures, what difference(s) you will bring into the procedures?

If it can be achieved by changing the attitude (of QA & other departments) then what steps would you recommend?