Preparation And Handling Of Working Standards
1.0 OBJECTIVE:
To
establish procedure for preparation and handling of working standards.
2.0 SCOPE:
This
procedure is applicable for all working standards which are to be used as
reference standard for analysis.
3.0 RESPONSIBILITY:
3.1
Doing: Technical
Assistant.
3.2
Checking: Executive/Manager.
4.0 ACCOUNTABILITY:
Head
of the Q.A Department.
5.0 PROCEDURE:
5.1
Select latest
approved batch of Raw Material preferably having maximum purity and minimum
impurity level.
5.2
Collect the
required quantity of material from the selected batch.
5.3
Give the reference
number to working standard as follows.
X000/A/BB
Where,
X= corresponds the first
alphabet of name of raw material.
000=
corresponds to Sr. No. starting from 001 continuously to have details of total
working standard in quality control laboratory.
A=
corresponds the last digit of year in which working standard prepared.
BB=
corresponds the no. of vial prepared for particular working standard starting
from 01.
5.4
For the second
reference standard of same material to be prepared in the same current year
then the suffix of alphabet A, B, C…… is to be added in the above logic with A.
i.e. X000/AS/BB
Where,
AS=
last digit of year with suffix.
5.5
Carry out the
following test for preparation of working standard.
5.5.1
Assay (in six sets
by two or more than two different chemists).
5.5.2
Loss on drying/
water content (in two sets by two different chemists).
5.5.3
Chromatographic
purity/ related substance.
5.5.4
I.R. (where
applicable).
5.6
Carry out assay
determination against reference standard wherever possible.
5.7
Enter the results
in the protocol of the respective material prepared as per SOP and also attach
the Xerox copy of original C.O.A.
5.8
Calculate the
average of six assay values obtained on as is basis. The RSD of these six
values should not be more than 1.0% for chemical assay and 5.0% for microbial
assay.
5.9
Store the material
in light resistant glass vials closed with rubber bungs and sealed with
aluminum seal.
5.10
Label the vials
with the following details.
5.10.1 Name
of working standard.
5.10.2 Ref.
No.
5.10.3 Assay
(as such).
5.10.4 LOD/
water content.
5.10.5 Date
of preparation.
5.10.6 Use
before.
5.11
Assign one year
shelf life for working standard except following working standard for which
assign shelf life six months.
5.11.1 Ranitidine
HCl.
5.11.2 Nifedipine.
5.11.3 Omeprazole.
5.11.4 Nicorandil.
5.11.5 Captopril.
5.12 Store
all additional vials of working standard in A.C control area (below 27oC)/
refrigerator (between 2 to 8oC).
5.13 Keep
one vial of each working standard in the allocated area in a plastic bottle
containing silica bag.
5.14 Every
month change the previous vial with fresh vial along with silica bag for all
working standard, by referring respective bin card.
5.15 Check
the % assay and LOD of each working standard on its expiry date as per initial
test method applied and record results.
5.16 If
the difference is more than 1%, between initial assay and assay on expiry
inform the department head.
5.17 In
case on expiry if new material is not available then extend the shelf life for
that working standard as per point no. : 5.10
or till new material received on the basis of the result obtain on retest.
5.18 Maintain
the issue record.
5.19 Destroy
the expired vials of working standard after completion of shelf life and keep
the record.
5.20 Procedure for
discard:
5.20.1 Empty
the contents in waste beaker containing water. After the material gets soften,
decant the water & transfer the paste into the polyethylene bag. This paste
is then sent to scrap.
5.20.2 Deface
the labels of the working standard vial or ampoules.
5.20.3 Discard
the vial & ampoule into the dust bin for broken glassware.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
8.1
Not Applicable.
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
S
|
Standard
operating procedure |
|
& |
And
|
|
% |
percentage |