by 1.0 OBJECTIVE
To lay down the procedure to Retention and handling of reserve sample of finished product.
2.0 SCOPE
This SOP is applicable for the Retention and handling of reserve sample (Control Sample) products manufactured .
3.0 RESPONSIBILITY
3.1 Quality Assurance (QA) shall be responsible for:
3.2 Sampling and handling of control sample.
3.3 Physical environment monitoring of control sample room.
3.4 Head – QA shall be responsible for:
3.5 Ensuring the adherence to the procedure as defined in the SOP.
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDURE
5.1 Withdrawal of Control Sample
The control sample shall be collect from each batch of finished goods manufactured .
In-Process Quality assurance (IPQA) Officer Shall Collect the Control sample from packing line.
The Quantity of retention sample for the finished product should be twice the quantity required for carrying out the complete analysis as per prescribed method of analysis.
| S.NO. | Control Sample | Quantity of sample drawn (in No.) |
| 1 | Softgel Capsule | 200 Capsules |
- Entry of the control sample collect shall be made in the BPR.
- The sample shall be stamped as ‘CONTROL SAMPLE’ for red colour ink the entry shall be taken in the record and shall be properly stored in the control sample room under storage condition according to the nature of the product.
- The record shall state the date of collection, product Name, Batch Number, Batch Size, Manufacturing Date, Expiry Date, Quantity Retained, Quantity Withdrawal, Due Date of destruction. Actual, destruction date, Quantity destroyed & Destroyed By .
- 5.2 Storage of control sample
- According to alphabetical manner store control sample in the racks.Control sample shall be segregated product wise. Store the control, sample in the control sample room under lock and key arrangements for a period of one six months beyond the expiry of the batches. The record of environmental monitoring of control sample room shall be maintained
- Physical observation of control sample Physical observation will be carried out after every six month and the observation records will be maintained.During physical observation following points shall be considered where ever applicable but not limited to:
Appearance/Description, Packing Quality, Imprinting, Overprinting, freely moveable of capsules, color Migration on capsules and capsule stick in printed foil.
In case, quantity of control sample / retention sample is required for testing/reference purpose, the same shall be issued only after the approval of the request, such withdrawal shall be recorded in ‘Finished product control sample logbook’.
5.3 Destruction of control sample
- Control sample & Retention sample shall be destroyed after Six Month of expiry date. For destruction of control sample refer ‘SOP on destruction of drugs products and its components.
- Destruction record of finished product control sample & raw material retention sample will be maintained in ‘Finished product control sample logbook.’
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
Display Copy : Quality Assurance (if required)
8.0 ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
