Standard operating procedure to allot a unique number to every Instrument/ equipment is describe in this post.
1.0 OBJECTIVE:
To
provide a system for allocating identification number to instrument/ equipment
in order to have better traceability and reference in all related documents.
2.0 SCOPE:
This
SOP shall be applicable to all instruments and equipments installed in quality
control laboratory.
3.0 RESPONSIBILITY:
3.1
Doing:
Quality Control department/ Production department.
3.2
Checking:
Quality Assurance Department.
4.0 ACCOUNTABILITY:
4.1
Head of Quality
Assurance Department.
5.0 PROCEDURE:
5.1 For Quality
Control Instrument/ Equipment:
5.1.1
Give
identification number to all instruments/ equipments as XYZ/QCE-000.
Where,
XYZ
= XYZ Pharmaceuticals.
QCE
= corresponds to the quality control equipment as per approved list available
in quality control department.
000=
corresponds to three numerical figures starting from 001 denoting the number of
instrument/ equipment in continuous manner.
As
per example of analytical balance XYZ/QCE-001.
001-Number
of the instrument in continuous manner.
5.1.2
Prepare the list
of instrument/ equipment with identification no. and get it approved by dept.
head.
5.1.3
Update the list
and approve it wherever require and give Sr. No. to list prepared.
5.2 For Production Machinery:
5.2.1
Give
identification number to all machinery as XYZ/PM-XX-00 or XYZ/PM-XXY-00.
Where,
XYZ=
______ Pharmaceuticals.
PM=
corresponds to the Production Machinery as per approved list available in
Production department.
XX=
corresponds to the section.
Y=
corresponds to the section number.
00=
corresponds to two numerical figures starting from 01 denoting the number of
machinery in continuous manner.
As
per example of U-type mixer XYZ/PM-PT1-01.
01-Number
of the machinery in continuous manner.
And
for semi-automatic capsule filling machine XYZ/PM-PC-16.
16-Number
of the machinery in continuous manner.
5.2.2
Prepare the list
of machinery with identification no. and get it approved by dept. head.
5.2.3
Update the list
and approve it wherever require and give Sr. No. to list prepared.
Annexure: 1
Codes
for production section.
|
Sections
|
Code
|
|
Production tablet
section-1 |
PT1 |
|
Production tablet
section-2 |
PT2 |
|
Production capsule
section |
PC |
|
Production sachet
section |
PS |
|
Production syrup
section |
PL |
|
Packing hall |
PH |
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