Instrument Calibration Laboratory setup for API Pharmaceutical Company

S

Santosh1981

#1
Dear Colleagues ,
We are a green field project and setting up a new API pharmaceutical plant in KSA.

I need your help for the following:

a) I need help to setup documentation system for calibration of critical
and technical isntruments.

b) In addition to this please advise we have all instrument delivered with
EN 10204 3.1 calibration certifcates , do we need to re calibrate them
again on site as they will be insterfaced with Plant DCS for controlling and monitoring.?

c) We have the normally used pressure and temperature instruments
installed for critical instruments. Please help in setting up the basic lab
setup and recommend calibration equipment.

Your help will be highly appreciated,

Thanks
Santosh
 
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v9991

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#2

a) I need help to setup documentation system for calibration of critical
and technical instruments.
your query is little generic...you will find scattered references...on documentation(including here in Elsmar)...viz.,
How to do Equipment Validation - Establishing our ISO 13485 QMS procedures

Also see:
http://www.fda.gov/ScienceResearch/FieldScience/LaboratoryManual/ucm171882.htm
http://www.fda.gov/ScienceResearch/FieldScience/LaboratoryManual/ucm171880.htm
http://www.fda.gov/ScienceResearch/FieldScience/LaboratoryManual/ucm171878.htm
http://www.fda.gov/ScienceResearch/FieldScience/LaboratoryManual/ucm171883.htm

whole lot of doc from FDAs QMS-lab-manual for compliance to 17025
http://www.fda.gov/ScienceResearch/FieldScience/LaboratoryManual/ucm171610.htm

anothre set from WHOs...
http://whqlibdoc.who.int/trs/WHO_TRS_957_eng.pdf#page=144
http://www.who.int/vaccines-documents/DocsPDF/www9666.pdf
Refer Pg.95 of following doc (Annex-I) and sec.12
http://whqlibdoc.who.int/trs/WHO_TRS_957_eng.pdf#page=95




b) In addition to this please advise we have all instrument delivered with
EN 10204 3.1 calibration certifcates , do we need to re calibrate them
again on site as they will be insterfaced with Plant DCS for controlling and monitoring.?
YES except for the ones which are to be used as master-calibrator(references..., the ones which are calibrated with traceability references to NIST etc)
+
it also makes sense to establish the compliance before(at the time of) use; moreover its your responsibility to establish the suitability of equipment. (ensuring it stands the shipment, re-assembling or integration into DCS etc)
+ this also depends on the way details are outlined in your validation master plan.

c) We have the normally used pressure and temperature instruments installed for critical instruments. Please help in setting up the basic lab setup and recommend calibration equipment.
this actually depends on AMC from manufacturer himself (he might cover the periodic calibration/maintenance of these instruments) or external agencies (contract) to support calibrations. ... these option again depend on the frequency and load of things which require calibration at your end...

hope this helps.
 
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