It is the policy of Pharmaceuticals Limited that the written procedure shall be followed for calibration of all Equipment/ Instrument at suitable intervals based on the manufacturer’s recommendation, historical experience, and criticality of use, used in the process of Manufacturing, Packing, Analytical division., Maintenance and Warehouse other than those Equipment / Instrument that are calibrated with each use.
This
procedure is to be applied at the time of preparation of the calibration schedule
once in a year for both house calibration and party Calibration.
The instrument/equipment is to be calibrated as per their individual
frequencies stated in the calibration schedule.
RESPONSIBILITY
Persons
along with their responsibilities are given below:
|
S.
No |
Designation |
Responsibility |
|
01 |
Executive
– Corporate Quality Assurance |
To
prepare procedures and coordination for calibration with the Outside party and
concerned department. |
|
02 |
Trainee
Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst |
To
follow the SOP accordingly |
|
03 |
Executive
– Quality Assurance |
To
prepare in-house and outside calibration schedule |
|
04 |
Manager
– Quality Control |
Execution
and overall responsibility for calibration with an Outside party and
concerned department |
|
05 |
Manager
– Quality Assurance |
To
ensure that calibration is being done accordingly. |
|
06 |
Manager
– Corporate Quality Assurance |
To
ensure the implementation of SOP |
PROCEDURE
Separate
calibration programs for in-house calibration and outside-party calibration
shall be prepared at the beginning of each year for all instruments/equipment
to be calibrated on dates as per their individual frequencies.
Calibration
of Equipment / Instrument shall
be carried out at suitable intervals based on the manufacturer’s recommendation,
historical experience, and criticality of use.
Calibration
standards for in-house or contract service must be traceable to a recognized National
Standard and within the calibration validity period.
All
traceability certificates shall be checked by the Department Head and reviewed
by a person responsible for calibration activities.
Both
In-house and outside calibration schedules shall be prepared by the concerned
departments as per Annexure I (Format for Outside Party Calibration Schedule)
and Annexure II (Format for In-house Calibration Schedule) and shall be handed
over to the Quality Assurance Department.
The
quality assurance Department on receiving schedules from the different
departments will prepare a composite Schedule for calibration and will send a
copy of the same to all concerned departments.
On
installation of new equipment, during qualification, all instruments that need
to be calibrated shall be identified based on manufacturer recommendation and
criticality of use. The user department will inform to Quality Assurance
Department about the same for inclusion in the calibration schedule on Appendix
- I.
On
procurement of new measuring instruments like, thermometers, Thermo
hygrometers, etc. the user department will inform to Quality Assurance
Department for inclusion in the calibration schedule in Appendix-I.
Once
the instrument is included in the calibration schedule, the Quality Assurance
Department will allot new ID no. of that series based on the type of instrument
and will inform the concerned department.
The
user department will inform to Quality Assurance Department about 30 days before the due date of calibration for outside party calibration so that necessary
arrangements can be made in Appendix III.
All
concerned departments are required to inform the Quality Assurance Department
whenever any instrument is replaced, out of use, damaged, out of calibration, or
when there is no calibration status label.
The
calibration schedule (both in-house and outside) will be a live document and
any inclusion can be made manually.
Although
all efforts will be made to calibrate the instrument/equipment on or before due
dates the following grace periods will be accepted based on the criticality and
frequency of calibrations:
Monthly:
1 Week
Quarterly:
1 Week
Half-yearly:
2 Week
Yearly:
4 Week
The
schedule shall have the following information:
Names
of
instrument/equipment
Identification
Nos. (ID
Nos.)
Frequency
of calibration
Outside
Party Calibration
In
the case of outside party calibration, a technical contract shall be signed
with the party specifying the general conditions of calibration using agreed
methods.
Calibration
shall be carried out at the site in presence of a supervisor/officer of the
concerned department.
If
calibration is not possible at the site, shall be sent to the site of an
outside agency.
Calibration
of Equipment / Instrument shall be carried out as per the Standard Operating
Procedure.
HOD
of the concerned department shall ensure that calibration is being carried out
as per SOP.
If
any equipment/instrument is found out of calibration, label it as “UNDER
MAINTENANCE”, update the Instrument History Card as per Appendix II and
inform Quality Assurance for appropriate action.
In
case the instrument is out of calibration it gets promptly reported and steps
are taken to remove it from service.
Instrument/equipment
shall not be further used till complies with the calibration requirements.
The
acceptance criteria for calibration of instrument/equipment shall be provided
by the company to the outside party agent.
On
the successful calibration of any equipment/instrument, the
calibrating agency personnel shall label the instrument with a calibration
sticker.
The
calibration sticker shall have information like date of calibration, Instrument
ID No., Calibration date, a signature of the person who carried out the
calibration, and the next due date of calibration.
The
calibrating agency shall issue a certificate of calibration in respect of each
instrument/equipment calibrated.
The
calibration certificate shall have details like identification of the
instrument, the range of calibration, standard calibrators used and their
traceability, the date of calibration, the actual values obtained, the date on
which the next calibration is due, and the signatures of the person who carried
out the calibration activity.
Each
certificate of calibration of instrument/equipment shall be reviewed by the
concerned Department.
Along
with these calibration certificates, the calibrating agency shall also provide
copies of the calibration certificates of the standard calibrators used,
traceable to National Standards.
All
traceability certificates shall be checked by the Department Head and reviewed
by a person responsible for calibration activities.
Ensure
that resolution (least count) of calibrator should be less than the resolution
of equipment/instrument to be calibrated.
The certificates shall be documented & maintained in the record.
In house Calibration
A
calibration schedule shall be prepared at the beginning of each year for all
instruments/equipment to be calibrated as per their individual frequencies.
Calibration
of instruments shall be done as far as possible in the location of its use.
In
case the instrument/equipment is found out of calibration, it shall be
immediately labeled “UNDER MAINTENANCE”, update the Instrument History Card as
per Appendix II and inform Quality Assurance for appropriate action.
In
case the instrument is out of calibration it gets promptly reported and steps
are taken to remove it from service.
Instrument/equipment
shall not be further used till complies with the calibration requirements.
After
successful calibration, the instrument shall be labeled with a Green
calibration sticker indicating the Instrument name, date of calibration, Tag
No. / ID No., the signature of the person who carried out the calibration, and
the next due date of calibration.
Calibration
reports shall be prepared by the person carrying out the activity and shall be
reviewed by the designated person and documented.
Maintenance
or moving of an instrument can alter the calibration status and accuracy of
data. Hence any such activity with the instrument shall be assessed and
recalibrated (whenever required) and the calibration record.
Re-calibration
shall be done in case of any maintenance or re-installation of instrument/equipment
(wherever applicable) and the record shall be maintained.
FOLLOW-UP FOR OUT OF CALIBRATION
The
details of ‘Out of Calibration’ shall be recorded in the logbook of the respective
instrument/equipment and informed to the Quality Assurance Department.
Fill out the form on SOP JOB ORDER attached in Annexure IV and send it
to the engineering department.
HOD
– Engineering shall take corrective action accordingly.
The
QA person shall assess the number of Samples affected or the number of analyses
affected and the impact of the same on the quality or system.
Record
the maintenance details in the log of the instrument/equipment.
Calibrate
the instrument/ equipment after rectification as per the respective calibration
SOP.
>List of Standard Operating Procedure
Record
the calibration in the log of the instrument/equipment
ANNEXURE
- I
|
S. No. |
Instrument |
Instrument ID |
Calibration Frequency |
J A N |
F E B |
M A R |
A P R |
M A Y |
J U N |
J U L |
A U G |
S E P |
O C T |
N O V |
D E C |
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ANNEXURE-II
|
S. No. |
Instrument |
Instrument ID |
Calibration Frequency |
J A N |
F E B |
M A R |
A P R |
M A Y |
J U N |
J U L |
A U G |
S E P |
O C T |
N O V |
D E C |
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APPENDIX
-II
|
S.No. |
Date
of Observation |
Problem
Found |
Corrective
Action |
Rectified
On |
Rectified
By |
Checked
By |
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REQUEST
FOR NEW INSTRUMENT I
Name
of Instrument ……………………………………………………………………………….
Date
of Qualification ………………………………………………………………………………
Details
of Instrument ……………………………………………………………………………...
……………………………………………………………………………………………………
……………………………………………………………………………………………………
Department
………………………………………………………………………………………….
Instrument
ID ……………………………………………………………………………………….
Requested
By: Checked
By: Approved
By:
(Section
In-Charge) (Manager
Technical) (Manager
Quality Assurance)
INSTRUMENT
HISTORY CARD
Name
of Equipment:…………………………………………………………
Instrument
ID: …………………………………………………………………
APPENDIX
III
REQUISITION
FOR CALIBRATION THROUGH OUTSIDE PARTY
Requested
to: …..
Requested
by: …………………………………………………………………………..
Name
of Instrument: …………………………………………………………………..
Instrument
ID:……………………………………………………………………………
Date
of Last Calibration:………………………………………………………………
Due
date of calibration:………………………………………………………………..
Prepared
By:
Approved By:
APPENDIX
IV
JOB
ORDER
Requested
By: ………………………………………………………………………………
Requested
To: ………………………………………………………………………………
Name
of Instrument: …………………………………………………………………………
Instrument
ID: …………………………………………………………………………………
Details
of Instrument: ………………………………………………………………………
Fault
in Instrument: ……………………………………………………………………………
………………………………………………………………………………………………
Prepared By: Checked By: Received By: