1.0
OBJECTIVE
To lay down the procedure
for Collection, Storage, and Destruction of control samples.
2.0
SCOPE
This SOP shall be applicable
for Collection, Storage, and Destruction of control samples.
3.0
RESPONSIBILITY
3.1
Chemist/Microbiologist shall be responsible for the
preparation of this SOP.
3.2
Chemist and above designee shall be responsible for the execution
of this SOP.
3.3
Manager QC and Manager QA shall be responsible for checking
and approval of this SOP.
4.0
ACCOUNTABILITY
Head QC
5.0
PROCEDURE
5.1
Collection
of Control Samples:
5.2 Chemist QC shall be drawn the samples from each of the
approved batch during the filling/packing; at least two samples shall be
collected randomly in polybags.
5.2.1
The quantity of the sample to be drawn is taken as according to QC
sampling process.
5.2.2
The sample shall be stored in the control sample room.
5.2.3 The control sample shall be stored in lock and key and key
shall be kept by QC in-charge or Chemist.
5.2.4 The sample shall be marked as “CONTROL SAMPLE”, and entry shall be taken
in Annexure I.
5.2.5 Depending upon the expiry of the product the sample is
periodically examined if needed and recorded.
5.3
Storage of the
control samples:
5.3.1
Control sample shall be store in the racks in a systematic manner.
5.3.2
Control sample shall be segregated product-wise.
5.3.3
Control sample shall be store in the control sample room under lock and
key arrangements for a period of one year beyond the expiry of the batch in
case of the finished product.
5.3.4 Ensure that the temperature and humidity of the hygrometer shall
be maintained and it should not be exceeding 27 0C &relative humidity 55%
respectively.
5.4
Destruction of control sample:
5.5
Destruction of control samples shall be done as
per the current SOP…………...
5.6
Destruction record shall be maintained in
annexure II.
6.0
REFERENCE
|
SOP No. |
Title of SOP |
|
|
Rejection & Destruction of IP and FP Product |
7.0
ANNEXURE
|
Annexure
No. |
Title
of Annexure |
Format
No. |
|
Annexure I |
Control Sample Record |
|
|
Annexure-II |
Destruction Record of Control
Sample |
|
8.0
ABBREVIATIONS
SOP : Standard Operating Procedure
No. : Number
Dept. : Department
QCD : Quality
Control Department
QA : Quality Assurance
QC : Quality Control
Mfg : Manufacturing
Exp : Expiry
Qty. : Quantity
Temp : Temperature
0C : Degree centigrade
% : Percentage
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