Gearing up GMP based systems for continual improvement.

v9991

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#1
long story cut short :
currently compliance scenario in pharma/medical device seems to be driven by 'evidence-based' and 'control-based' verifications!
what steps needs to be taken [by both industry and regulatory] to move the pharma/Device-'systems-implementations' towards continual improvement?


Background :
GMPs traditionally lay emphasis on procedures-controls-validations-and-documentation.

The most famous adage in pharma industry is that..."If its not documented its probably not done!!.."

By and large, the whole emphasis of 'compliance' for both product-quality and quality-systems revolves around 'documentation!' and adopted by every regulatory agency! If there is any digression then its there for some extent on 'controls' !...

Moving away from the above scenario...although agencies started to talk about the aspects such as:
1. Quality systems - approach to GMPs;
2. Risk based approach to GMPs;
3. PAT etc
The momentum is yet to pick up. [I might be corrected here if there are better informed persons of the industry trends in adopting the above approaches!]

And my following query is about one of the bottle-neck/problem/ambiguity which I feel is hampering the progress towards the "evolution of GMPs" which will certainly benefit agency & industry alike.

Of the aspects mentioned above,
point 2 and 3 are probably understandable for me! And more of concept/technology oriented;
when it comes to point 1; quality systems approach to GMPs, can anybody help me outline the changes required and how to measure/follow-up them.

Queries:!:
1. What changes are required to be made [to SOPs] in order to take make it aligned with “quality systems approach to GMP.”
2. How do we measure them for compliance; do we follow the same procedure through documentation!.
3. Apart from the compliance how do we focus continuous improvement...

You can also share your thoughts on the sequence of steps; challenges; bottle-necks; and the way forward. etc.,

Thanks in advance.

valiveti
 
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M

MIREGMGR

#3
Perhaps I don't understand the intended point, but I don't see a fundamental disconnect between the FDA's GMPs and a "continual improvement" approach...assuming that the latter is applied with a sufficiently rigorous expectation of substantial compliance before sales/deliveries are permitted.

I must say that my experience with 13485/MDD to date in the medical device world has been that those auditors with whom we have dealt have sometimes been overly willing to accept evidence of continual improvement in areas of marginal adequacy. I've seen a couple of instances so far in which they have postponed judgment on marginal issues until the next regular inspection, instead of requiring that the system be fully effective in order for shipments to be permitted. In that regard, my perspective is that a goal=continual-improvement system may at times be less effective than a goal=compliance-now system...with the degree of difference being dependent on auditor judgment calls.

Assuming, though, that the audit process is sufficient rigorous, I don't see why adding a continual-improvement expectation to an existing requirement for GMP compliance would be complicated or disruptive.
 

v9991

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#4
obviously, one has to ask right:eek: question to get an apt answer! let me try to refine my query

currently compliance scenario in pharma/medical device seems to be driven by 'evidence-based' and 'control-based' verifications!
what steps needs to be taken [by both industry and regulatory] to move the pharma/Device-'systems-implementations' towards continual improvement?

quick response to the thoughts from 'Miregmgr'
1. "...Perhaps I don't understand the intended point,..."..i hope the revised query clarifies!...

2. "...disconnect between the FDA's GMPs and a "continual improvement" approach...assuming that the latter is applied with a sufficiently rigorous expectation of substantial compliance before sales/deliveries are permitted...."; how would you qualify the words "sufficient...rigorous... and 'substantial" compliance... and thats exactly is my query. my impression is that there are little references/case-studies available to the end-users which could help them get on track.

3. "...In that regard, my perspective is that a goal=continual-improvement system may at times be less effective than a goal=compliance-now system...with the degree of difference being dependent on auditor judgment calls..."now, that [only!] signifies need to comply[ or over-come] the deficiency in the system/process ; where is the drive to inculcate the continuous improvement...make it quality-culture irrespective of the regulatory-audit...

4. "....Assuming, though, that the audit process is sufficient rigorous, I don't see why adding a continual-improvement expectation to an existing requirement for GMP compliance would be complicated or disruptive...."i am sorry:bonk:if my first query has lead to that impression; nevertheless, could you further your thoughts with examples/areas/procedures to make "continuous improvement" a critical cornerstone of GMPs.

anyway thanks for your thoughts.
 
M

MIREGMGR

#5
Is your interpretation that "continuous improvement" should retain the same priority once the quality system has achieved a level of performance that results in a very high level of assurance that all delivered products are safe and effective as defined by relevant standards and as evidenced by post-market user information?

My perception is that in the 13485/MDD medical device world, there is a general perception of a threshold of high performance at which the above goal has been reached. Improvements beyond that threshold are of course welcome, but not essential and do not justify changes and costs that could create a risk of diminishment, rather than improvement, of product quality. Thus "continual improvement" is a non-linear goal.

Certainly in the FDA GMP world, in the absence of 13485/MDD, the concept of a threshold of acceptable performance ("not good enough to deliver safety and effectiveness" or the converse) is well established.

In my experience, it's not common in the medical device world to perceive continual improvement without reference to the state of the products relative to defined requirements and the costs and risks associated with further changes, as desirable.

To specifically address one of your comments: my perception is that an organization operating per FDA GMPs can relatively simply add continual improvement to its QMS by adding ISO 13485/MDD compliance and certification to its regulatory focus.
 
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