Q.C Laboratory Safety SOP
1.0 OBJECTIVE:
To
lay down procedure for receipt and maintenance of working standards of API.
2.0 SCOPE:
This
procedure is applicable for receipt and maintenance of working standard of In-process
stages and Raw Materials received at API plant.
3.0 RESPONSIBILITY:
3.1
Doing: Technical Assistant/ Executive.
3.2
Checking: Executive/ Manager.
4.0 ACCOUNTABILITY:
Head
of the Q.C Department.
5.0 PROCEDURE:
5.1
To prepare a working standard of
In-process/ RM follow as below.
5.2
Take any commercial batch, which is
recently manufactured at the API plant, for the preparation of In-process
standards and for Raw Material any material received recently at store or AR/GR
grade can be considered for working standard preparation.
5.3
Take approximate 50g of sample from the
latest batch and analyse twice as per available specification and method, and
compare with reference std. available. The difference between two assay results
should not be more than 0.5%. Average of the results are recorded as per
Annexure-I.
Prepare
vials accordingly and affix the labels indicating product name, stage no.,
working standard no., effective date, use before and potency of the material
and vial no.s.
5.4
Ask to process development lab in-charge
to go for performance trial for next stage of the same.
5.5
If performance trail report is passing as
per specification, prepare the working standard of the selected stage/RM and
attach performance trail report with the working standard report.
5.6
Working standard No.s are to be allotted
as below:
For
In-process standards: BDIP/XXX.
For
Raw material standards: BDRM/YYY.
Where,
XXXand YYY stand for serial no. in three digits.
5.7
The log register is maintained for the
receipt and issue of the material in computer or a hard copy maintaining
product name, stage/ batch/ lot/ A.R. No., date of receipt, date of analysis,
received quantity, No. of vials prepared, No. of vials issued, issued date,
etc.
5.8
Give A.R. No. same as number allotted to
working standards.
5.9
If all entries are maintained in computer
it should be protected and whenever the changes are made the printout should be
taken and signed by Executive or Asst. Manager-QC.
5.10
In the case of solvents used as standards
use AR/ GR/ HPLC grade solvents as standards.
5.11
The report of working standard should be
filed in working standard file.
5.12
Prepare new W.S before the existing
standard is exhausted or before two years are completed from the date of
report; whichever is earlier.
5.13
Store the W.S. vials at ambient
temperature or the temperature shown on the label.
5.14
Perform all the test of working standard
on its expiry date as per latest test method and record the results per
Annexure-II.
5.15
If the results meet the specification it
can be reuse as working standard for further six months. After six months it is
to be destroyed.
5.16
Destroy the expired vials of working
standard after completion of shelf life and keep the record in the log register
maintained as per clause5.7, stating
the No. of vials destroyed, destroyed on and destroyed by.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
01/07/2020 |
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
Annexure 1: Certificate
of analysis.
Annexure 2: Certificate
of Reanalysis
Annexure:
1
Certificate
of analysis
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QUALITY CONTROL DEPARTMENT CERTIFICATE OF ANALYSIS |
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Name
of product:
W.S. No.: Date
of testing:
Batch NO.: Effective
date: Qty. in gms: Use
before:
A.R. No.: Ref.
Std. No.:
No. of vials: Analysed
as per: |
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Sr. # |
TESTS |
LIMITS |
RESULTS |
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Test protocol as per specification |
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Remarks: complies/ does not comply as per above
specifications. |
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Prepared
by: Date: |
Checked
by: Date: |
Approved
by: Date: |
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Annexure:
2
Certificate
of Reanalysis
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QUALITY CONTROL DEPARTMENT CERTIFICATE OF REANALYSIS |
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Name
of product:
W.S. No.: Date
of testing: Batch No.: Effective
date:
qty. in gms: Use
before:
A.R. No.: Ref.
Std. No.:
No. of vials: Analysed
as per: |
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Sr. # |
TESTS |
LIMITS |
RESULTS |
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Test protocol as per
specification |
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Remarks: complies/ does not comply as per above
specifications. |
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Prepared
by: Date: |
Checked
by: Date: |
Approved
by: Date: |
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9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
S
|
Standard
operating procedure |
|
& |
And
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% |
percentage |