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Instrument Calibration FIND HERE
Handling Procedure Search
Janki Singh (https://guideline-sop.com/author/janki- ABOUT THE
AU T H O R
singh/) -
27/05/2021 Mrs. Janki Singh is the
professional
pharmaceuticals Blogger.
She has already posted
Standard Operating Procedure (SOP) for Handling Procedure
of Instrument Calibration in Quality Control Laboratory. more than #1000 articles
on varrious topics at
Calibration: The set of operations that establish, under different blogging
specified conditions, the relationship between values plateforms.
Contact :
indicated by a measuring instrument or measuring system, or
[email protected]values represented by material measure and the m
corresponding values of the measured.
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Handling of Instrument Calibration
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1.0 Objective delivered to your email a
few times a month.
To lay down a procedure for handling of calibration of
Updates and news about
the various instrument (s) in the Quality Control
all categories will send to
department.
you.
2.0 Scope
Your Email GO
This SOP is applicable for the handling of calibration
of the various instrument (s) in the Quality Control Accept GDPR Terms
Laboratory.
C L A S S I F I C AT I
ON
3.0 Responsibility
Quality Control Chemist/Officer/Executive: Ask Question
Responsible for following the procedure, preparation, (https://guideline-
updating, tracking, and review of calibration calendar. sop.com/category/ask-
question/)
4.0 Procedure – Instrument Calibration
Calibration
All the instruments shall be calibrated as per the
(https://guideline-
frequency mentioned in the SOP of the respective
sop.com/category/calib
Instruments.
ration/)
Preparation, updating, and tracking of
Intrument Calibration Calendar
Preparation of calibration calendar Checklist
(https://guideline-
For the Calibration schedule, QC shall generate a
sop.com/category/chec
calibration calendar as defined in Annexure – I at the
klist/)
end of the year for the next calendar year.
The calibration calendar shall comprise a month-wise Maintenance
calibration schedule (refer to Annexure – I). (https://guideline-
sop.com/category/eng
The calendar shall be signed by the quality control
g/)
department Chemist/Officer/Executive followed by
Head QC or his designee and finally shall be approved
Microbiology
by Head QA or designee.
(https://guideline-
sop.com/category/micr
Updation of calibration calendar
obiology/)
Any addition of the instrument to the calibration
calendar shall be done after completion of the Production
Qualification of the respective instrument. (https://guideline-
sop.com/category/prod
The calendar shall be updated with the inclusion of the uction/)
instrument and shall be commented accordingly in the
comment column of the Calendar followed by the Quality
signature of the respective department (https://guideline-
Officer/Executive, Head quality control, or his designee sop.com/category/quali
and approval of Head QA /designee. ty/)
In case of removal of the Quality Assurance
machines/systems/instrument from the area/facility, (https://guideline-
the same shall be marked with an asterisk and shall be sop.com/category/quali
explained in the comment column followed by the ty/qa/)
signature of the respective department Officer /
Quality Control
Executive / Head quality control or his designee and
(https://guideline-
approval of Head QA /designee.
sop.com/category/quali
Tracking of Instrument Calibration Calendar ty/qc/)
The QC- Chemist/ Officer / Executive shall refer to the
calendar and arrange for the Instrument’s availability Quality IT
for calibration in coordination with the concerned area (https://guideline-
to ensure calibration is performed as per the calendar. sop.com/category/quali
ty-it/)
Once the calibration is performed, the QC- Chemist/
Officer / Executive shall track and update the calendar SOP's
to indicate the completeness of activity. (https://guideline-
The same to be done by updating the tag for the sop.com/category/sops
respective instrument. /)
The Calibration calendar shall be reviewed for
Stores
compliance on monthly basis by the Head of Quality
(https://guideline-
control or his designee and shall be signed
sop.com/category/store
accordingly.
s/)
Update the calibration status label (Refer SOP – Status
Validation
Labeling (https://www.pharmabeginers.com/sop-for-
(https://guideline-
status-label-in-production/)) on the instruments after
sop.com/category/valid
completion of calibration.
ation/)
The “cal. due date” on the tag shall be as per the
calibration calendar. The calibration due date shall be F O L LO W U S
assigned as follows:
(https:/
E.g. Instrument Calibration
Date Frequency Cal. due date
/twitter
HPLC 02-02-2021 There
6 months
.com/G
has
02-08-2021 been a
critical
(https:/
uidelin
Friability 02-02-2021 error on
1 month your
02-03-2021 /twitter
Learn
website.
eSop)
Calibration shall be performed on or before the due
.com/G
more
(https:/
date of calibration or unscheduled
maintenance/breakdown then the Calibration due
date shall be as usual as defined in the calendar. uidelin
about
/twitter
Handling of failure during calibration debug
eSop)
.com/G
If an instrument fails in a particular calibration test
ging in
uidelin
then shall be handled as per SOP “Handling of out of
calibration (https://guideline-sop.com/out-of-
calibration-ooc/)”. WordP
eSop)
In the case where the calibration/validation activity is
ress.
completed in multiple days, the date of
calibration/validation shall be taken as the date of
(https:/
completion of the calibration/validation activity.
/wordp
The instruments out of the calibration validity period
ress.or
shall not be used and shall be appropriately labeled to
avoid further use.
g/supp
Calibration shall be ensured before the use of this
instrument. ort/arti
Instrument performance Qualification / Re-
Qualification / Re-Validation / Temp. cle/de
The mapping study shall be done as per pre-approved
buggin
protocol. Preparation / Review / Approval of the
protocol shall be done as per the Validation Master
g-in-
Plan.
For instrument monitored daily for 24 hrs like Stability wordpr
chamber, Incubator refrigerator and qualification
activity required multiple days for an instrument such ess/)
as autoclave all these instruments may be used for
routine usage, during re-qualification / re-validation /
temperature mapping as applicable.
However, after completion of re-qualification / re-
validation / temperature mapping compliance to pre-
defined acceptance criteria shall be evaluated.
If it fails to meet the criteria, impact
assessment shall be carried out with the
help of QA.
After completion of the activity, the completion date
shall be put as a calibration date in the calibration
calendar.
After completion of calibration activity, the details
shall be entered in the respective instrument usage log
book.
“Instrument Usage Status” as per Annexure-II shall be
used as and when an instrument is taken for analysis.
Verification of Validity of Calibration
standard
Validity of calibration standard shall be checked at
regular intervals (once in two months) and record the
details in Annexure – III.
Purchase orders of calibration standards shall be
prepared about two months before the expiry or
validity date of the calibration standard.
5.0 Annexure – Instrument Calibration
Annexure-I: Calibration calendar
Year :
Calibration Calendar Area: Quality
Control
Page no.: X of
Y
Calibration SOP
No.
Sr. Instrument Instrument Frequency SOP
No Name Number No.
Monthly JAN
review by
Head or
designee Sch Act
QC
Annexure -II: Instrument Usage Status
INSTRUMENT USAGE STATUS
INSTRUMENT ID:
PRODUCT
BATCH NO.
TEST
ANALYST (SIGN/DATE)
Format No.
Annexure – III: Validity checklist for Calibration
standards.
Sr. Name of Lot Lot Validity Verified Remarks
No. Calibration No. Valid Date By/Date
Standard or
not
Janki Singh (Https://Guideline-
Sop.Com/Author/Janki-Singh/)
Mrs. Janki Singh is the professional
(https://gui
pharmaceuticals Blogger. She has
deline-
already posted more than #1000 articles
sop.com/au
on varrious topics at different blogging
thor/janki-
plateforms. Contact :
singh/)
[email protected] YOU MIGHT ALSO LIKE
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