SOP For sampling of finished product is described in this post which you can follow in the section of the Quality Assurance Department.
OBECTIVE
This procedure is established to provide system for sampling of finished products for storage as control samples.
SCOPE
This procedure is applicable to Production Department
RESPONSIBILITY
Production Pharmacist
QA Officer
ACCOUNTABILITY
Manager Quality Assurance
PROCEDURE
Sampling of Finished Products should be done during online packing.
Finished products should be collected at different intervals, i.e. start, middle and end of the packing operation.
After completion of the batch, bring the samples to the Quality Control Department.
Enter the product name, batch No. and quantity sampled in QC Retained Sample Record.
Retain collected samples as per table given below as control samples after sampling and retain in the retention room.
Sr# |
Dosage Forms |
No.
of Units |
1. |
Powder for oral suspensions |
10
Units |
2. |
Capsules 6’s & 8’s |
09
Units |
3. |
Capsules
10’s |
05
Units (50 caps) |
4. |
Capsules
14’s |
04
Units |
5. |
Capsules
20’s |
03
Units |
6. |
Capsules
50’s &100’s |
01
Unit |
7. |
Tablets
6’s & 8’s |
09
Units |
8. |
Tablets10’s |
05
Units (50 tabs) |
9. |
Tablets
14’s |
04
Units |
10. |
Tablets
30’s |
02
Units |
11. |
Injections
(1’s) |
10
Units |
12. |
Syrup |
10
Units |
NOTE: 05 units of P/S of each product will be retained as a control sample.