by - OBJECTIVE
To lay down the procedure for Dispensing of Raw Materials.
- SCOPE
This SOP is applicable for Dispensing of raw materials in Stores.
- RESPONSIBILITY
Store Personal : Dispensing of raw materials as per BMR requisition slip. Transfer of dispensed materials to designated location as per the requirement.
- ACCOUNTABILITY
Stores In-charge : For system Compliance
- PROCEDURE
- After receipt of Batch Manufacturing Record, including requisition Stores personnel shall print the issue slip and batch sheet from electronic system.
- Stores personnel shall verify the availability of A. R. No. wise materials in approved raw material store for the batch.
- Wherever is applicable ensure the potency calculation shall be performed by production and stores and checked by Q.A.
- If all raw materials are found as per the requirement, material containers shall be taken to material Airlock of Dispensing Area shall be kept on pallets.
- Stores personnel/ Q.A shall verify each container for following details:
- Approved label
- ‘Sampled’ label in case material seal is opened.
- ‘Loose’ Label from which container or bag, the material is dispensed earlier.
- A. R. No. as per weighment sheet.
- Physical condition of each container i.e. cleanliness, seal, status labels etc.
- If any discrepancy found during the verification of document or physical condition of material, Stores personnel shall inform to QA.
- Based on the impact assessment Executive/head QA shall take the decision for accepting or rejecting the material “On-line rejection”.
- After physical and document verification, Stores personnel shall check the dispensing area following the check list as given in BMR and shall record the observations.
- Check the cleaning of area and its record.
- Availability of sufficient quantity of clean dispensing tools.
- Availability of sufficient quantity of aprons, shoe covers and snood.
- Availability of IPC bins / pallets or polythene bag and cable tie.
- Cleaning of RLAF and its record.
- Ensure that the AHU is switched on prior 30 minutes of start of dispensing activity.
- Ensure that the RLAF is started prior 30 minutes of start of dispensing activity.
- Pressure differential across the HEPA filter shall be between 7 – 15 mm and across pre-filters between 2 – 5 mm.
- Ensure that the Weighing balances are calibrated and records are maintained, Check the calibration records.
- Check the calibration due date of pressure gauges, temperature and hygrometer monitoring device and validation due date of RLAF. Inform the Engineering department for calibration / validation of above devices at-least one month before the due date.
- Check the dispensing log book for the previous entry.
- Check the temperature and relative humidity of dispensing area and record in BPCR. The temperature of area shall be 25±2°C and relative humidity shall be between 45±5 percent.
- After checking of area and documents Stores personnel shall inform the QA officer to verify the details for line clearance.
- After QA officer verification and approval, Stores personnel shall start the dispensing activity as per following the below procedure:
- After dispensing activity shall be recorded. Cleaning of area shall be done as per SOP. “and Cleaning of Dispensing area” and records shall be maintained.
- Any discrepancy observed during dispensing shall be informed to Stores In-charge for corrective and preventive action following SOP and “Deviation Control”.
- Dispense the raw materials in double polythene bag keeping the duly filled and signed identification slip between the polythene bags. For solvents affix the duly filled and signed identification slip on the containers.
- Transfer the dispensed raw materials to dispensed material air lock, from where these shall be transferred to production.
- Dispensing shall be done in the given below pattern.
| Excipients | → | API | → | Colour | → | Colloidal Silicon Dioxide |
- Dispensing of Powders:
- Dispense the material under RLAF.
- Dispense the loose quantities in the fresh polythene bags.
- Place the fresh polythene bag on the balance platform and record the weight in the issue slip and tare the weight.Open the container, scoop out the material as mention in issue slip using cleaned scoop and this shall be put into the polybag which is on the weighing platform.
- Stores personnel shall sign the Issue slip and place it between the polythene bags.
- Dispensed material shall be handed over to production chemist in dispensing area and with the help of store helper dispensed material to be transferred to Production area.
TRAINING
Trainer : Head – Quality Assurance
Trainees : Store-Incharge, Workmen
DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Stores
Display Copy : Stores (if required)
ATTACHMENTS
| Sr. No. | Annexure No. | Title | Format no. |
| 1 | NA | NA | NA |
- REFERENCES
In-house
ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
