1. OBJECTIVE
To lay down a procedure for storage & transfer of dispensed raw material in quarantine
2. SCOPE
This procedure is applicable for all dispensed raw material in quarantine of all products to be manufactured
3. RESPONSIBILITY
• Doing: Operator
• Checking: Production Pharmacist or above
4. SAFETY INSTRUCTIONS
N/A
5. PROCEDURE
5.1 The material to be dispensed as per the manual calculation & system generated SAP or pre-dispensing sheet duly signed & Checked by Q.A. person, production person & store person.
5.2 The full batch once dispensed in dispensing area should be transferred to the Production Quarantine through pass box to the production person ,which will cross verified the dispensed material as per the dispensing labels.
5.3 Once verified, the production person has to prepare & affix the under process status label as per SOP on the containers by writing full information like no. of containers, the dispensed raw material, ready for granulation, Batch No, Batch size, Mfg. Date, Exp. Date, sign & Date etc.
5.4 Segregate properly all the dispensed raw materials on the basis of container no. on the under process labels to avoid the batch mixing in production Quarantine
5.5 When the dispensed material to be taken to for manufacturing, the production person has to cross verified all the dispensed material weights as per the dispensing slips
5.6 Note:
5.6.1 The Production quarantine should be always in lock & key.
5.6.2 The dispensed raw material should be stored in Production Quarantine to 15 days then it should be again verified for the weight.
5.6.3 Empty Hard Gelatin Capsules to be dispensed just prior to the filling.
5.6.4 If the API material is sensitive in the Storage conditions then it should on priority after dispensing and follow all necessary storage instructions.
5.6.5 Once the containers get empty from the dispensed raw material, it will be immediately sent for cleaning to the washing area.
5.6.6 Weights to be checked on the calibrated balance only.
6. RELATED DOCUMENTS
N/A
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Warehouse Department | 01 | , |
8. ABBREVIATIONS
SOP Standard Operating Procedure
Q.A Quality Assurance
HOD Head of the Department
10. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 29/08/2022 | 00 N/A | First Version |