STANDARD OPERATING PROCEDURE CONTROL SAMPLES
STANDARD OPERATING PROCEDURE
|
SUBJECT :
CONTROL
SAMPLES
|
DEPARTMENT : QA
SOP
NO. :
Page
No :
Effective
Date :
Next
Review :
Version
No :
|
1.0 OBJECTIVE:
To
provide guidelines for Storage and Handling of control samples of finished
products and Raw materials.
2.0 POLICY:
To collect the control samples for storage and future
reference.
3.0 PROCEDURE:
3.1
FINISHED PRODUCT
3.1.1. Control
samples for all the batches of finished products released by Quality Assurance
will be preserved; The quantity will be three times the quantity required for
testing as per the specifications.
3.1.2.
Each sample shall be identified with
“Control sample. Not for sale”.
3.1.3. The
racks containing control samples have to be properly identified with the
Product name & Batch No. for easy retrieval.
3.1.4. The samples will be arranged suitably in a
racks and the room is under lock and key.
3.1.5. A record
for control samples will be maintained and kept in the area .The detail include
Disposal date and signed by Q.A personnel.
3.1.6. Withdrawal
of control samples shall be recorded in the register with the reason for with
drawl and quantity and should be signed by site Q.A.
3.1.7. The
control samples will be discarded one year after the expiry date, after
intimation from parent company.
3.1.8. While
discarding the samples care is to be taken that label on the container and
content inside are destroyed completely.
3.1.9.
The tablets from the foil are taken out
and destroyed, the foil is burnt completely
3.1.10.
Records are to be maintained
for each sample discarded after the expiry date.
3.1.11. Samples
to be collected for every 5th batch of the product for inspection.
(As per the requirement of parent company, for DRL only)
3.1.12. Control
samples shall be reviewed once in three months & shall be recorded, for DRL
only.
3.1.13 The control
samples were checked visually for colour, odour and particulate matter &
shall be
recorded.
3.2
RAW MATERIALS:
3.2.1. The
Control samples of the Raw material i.e., other than the acids, corrosive
material will be preserved.
3.2.2. Sufficient
quantity of such Raw materials will be preserved in suitable containers bearing
label with details.
3.2.3.
Samples for such Raw material will be
stored in rack in a segregated area at ambient temp.
3.2.4. The
control samples of Raw material will be preserved till the expiry of finished
product, in which it has been used lastly.
3.2.5. The
samples which have completed date of expiry will be discarded and documented.
Control samples will be disposed as per procedure described in SOP NO. 62/QA
3.2.6. Executive
/ Jr. Executive will prepare the list of samples of Raw materials /finished
product for destruction purpose.
4.0 FREQUENCY: As and when required.
5.0 RESPONSIBILITY: G.M (Q.A)/ QA Executive.
6.0 ANNEXURE:
1. Control Sample Size for Different
Products.
2. Review
of control samples.
3.Control
sample withdraw register.
7.0 SOPs
DISTRIBUTION:
This
SOP shall be distributed to following Departments:
|
Name of the Department
|
Master Copy
|
Circulatory Copy
|
|
QA/QC
|
√
|
√
|
|
Production
|
x
|
x
|
|
Warehouse
|
x
|
x
|
|
General
|
x
|
x
|
|
Maintenance
|
x
|
x
|
Comments
Post a Comment