Design & Documentation of Control Systems and Procedures

What kind of system is more reliable, self sustaining / continuous-improving ?

  • Comprehensive definition of procedure with inadequate implementation or effectiveness

    Votes: 1 25.0%
  • Minimalist definition of process/procedure with effective implementation of it in letter & spiriti

    Votes: 3 75.0%
  • Comprehensive documentation but records created offline.

    Votes: 0 0.0%
  • Online documentation but leaves a lots of improvement for complete details

    Votes: 1 25.0%

  • Total voters
    4

v9991

Trusted Information Resource
#11
v9991,

It sounds like pharma management has QA exactly where they want them.

A shield from any responsibility for getting their work right the first time.

And independence compromised when it comes to audit.

John
.,
there are countries where batch release is done by Qualified-Personnel, or approved chemists (QA)!
and obviously, QA would represent the external/regulatory audits and complaints/investigations.
incidently, its not any-often that QA is seem to be driving the improvements!!! beyond the scope of regulations-compliance

i am not saying that is the reason for it, but its a way to ensure that ALL KEY steps are adhered. (remember...regulation says that if we are not ensuring identified key steps, even if the product is good is it is adulterated...misbranded...not of quality etc)


I cant comment whether its pharma management or regulators, ....i am little lost...whether its need of standard! comprehensive as that of ISOs, six sigmas, (i think ICH Q10s are the answer for same) and offlate, regulators have been pushing for improvements/investigations,trends, CAPAs (interestingly, yet also in opposite documentation from documentation--> integrity)
Clearly we need to move onwards from procedures, checklists towards better tools, of effectiveness and efficiencies... ( PDCAs, COQ, Sigma levels, etc.,)
but surely we will be there and moving in right direction....
 
Last edited:
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v9991

Trusted Information Resource
#12
v9991,

I chose:

Minimalist definition of the documented procedure implemented with an effective process in both letter and spirit.

My corrections reflect the fact that the process is the work and the procedure (documented and undocumented) is the specified way of carrying out the work.

John
also can you pl. suggest on another aspects of documentation!
 
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