Systems to Handle Development and Batch Analysis in same Laboratory

v9991

Trusted Information Resource
#1
Quality control analysis would require appropriate levels of procedures - documentation - final review&approval.

on the other hand the development activities have steps pertinent for finalization of product/method etc.,(typical R&D setup)

the question is, what are additional controls/challenges for "IF & WHEN" we have to use same facility & personnel for carrying out the development samples. viz., same equipment being used for carrying out development trials, and subsequently.or.intermittently for analysis batch-release samples.

Differences could be.,
* level of documentation maintained for carrying out the analysis.
* investigation of exceptions, outliers etc.,
* extent of review and oversight required
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Quality control analysis would require appropriate levels of procedures - documentation - final review&approval.

on the other hand the development activities have steps pertinent for finalization of product/method etc.,(typical R&D setup)

the question is, what are additional controls/challenges for "IF & WHEN" we have to use same facility & personnel for carrying out the development samples. viz., same equipment being used for carrying out development trials, and subsequently.or.intermittently for analysis batch-release samples.

Differences could be.,
* level of documentation maintained for carrying out the analysis.
* investigation of exceptions, outliers etc.,
* extent of review and oversight required
The simplest way would be to have 2 different sets of procedures & forms. You could use different colour paper for each, to make it visibly obvious whether the right forms are being used.

Once you establish the system train your staff and monitor function regularly for a while, until it becomes second nature.
 

v9991

Trusted Information Resource
#3
The simplest way would be to have 2 different sets of procedures & forms. You could use different colour paper for each, to make it visibly obvious whether the right forms are being used.

Once you establish the system train your staff and monitor function regularly for a while, until it becomes second nature.
from QMS design, Yes indeed, these are the steps., one would go through; :agree:

I must have added the context :bonk:, if this approach would fly with the
* agencies audit review.
* compliance to requirement (viz., one activity having additional step of review for batch release; and no formal/specific review in case of development trials)
 

Ronen E

Problem Solver
Staff member
Moderator
#4
from QMS design, Yes indeed, these are the steps., one would go through; :agree:

I must have added the context :bonk:, if this approach would fly with the
* agencies audit review.
* compliance to requirement (viz., one activity having additional step of review for batch release; and no formal/specific review in case of development trials)
in my opinion as long as you write what you do and do what you wrote, there should be no issues.
 
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