- OBJECTIVE:
- To lay down the procedure for dispensing of excipients in dispensing booth.
- SCOPE:
This Procedure is applicable for dispensing of excipients in dispensing booth warehouse department at {Company Name} {Location}.
- RESPONSIBILITY:
- WH Executive/Designee – is responsible for ensuring compliance with the SOP.
- Production Head- Shall be responsible to ensure the compliance as per SOP.
- Head Warehouse – is responsible for compliance of the SOP.
- ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
- PROCEDURE:
- PRE CHECKS
- Check the cleanliness of the area and the equipment, scoops/utensils etc.
- Use separate cleaned scoops/utensils for dispensing of each excipient material.
- Empty containers/bags shall be sent to scrap yard after defacing the container labels.
- Ensure that the required environmental conditions & room differentials pressure are as per requirements.
- Before starting the dispensing check the balance for calibration status.
- DISPENSING PROCEDURE:
- After receiving the indent/BMR from the Production department, check for the availability of the raw material stock. Then fill the required quantities and Lot No. in the Batch Manufacturing Record. Dispense on FIFO basis.
- Transfer the required excipient material to the dispensing material entry. Keep the material at designated place & de-dust the material containers with the vacuum cleaner/dry lint free cloth if required. Ensure that every container/package is having approved label.
- Take the line clearance from IPQA for dispensing activity as per respective procedure.
- Production personnel has to verify the materials approved Status of Material, Name of Material, Material Code, Lot Number and Quantity as per respective BMR before starting the dispensing.
- Personnel involved in dispensing activity shall enter into the dispensing room after proper gowning.
- Start LAF for dispensing booth as per current version of SOP & record differential pressure of the booth before starting of the dispensing activity.
- Dispensing activity shall be carried out within the safe working zone of dispensing booth.
- Dispense the material one after the other as mentioned in Batch Manufacturing Record. Dispense all the ingredients mentioned in BMR as per procedure mentioned in the bellow points.
Note: Dispensing personnel shall wear goggles & hand gloves at the time of dispensing. First dispense inactive ingredients then colors or flavors.
- Dispense the required quantity of material into pre weighed double lined polybag in presence of Production personnel. Record the gross weight and Net weight in BMR and concerned stores and production personnel shall sign off all cells in the dispensing sheets of the BMR.
- Liquids shall be dispensed on weight basis in containers based on specific gravity as per in house certificate of analysis.
- Fill the weighing details in material issue tags. Store personnel shall sign on the material issue tags at the dispensed by column, and Production personnel shall verify the dispensed material with respect to all the details on the Material Issue Tag and sign at the received by column of the Material Issue Tags.
- Keep the material issue tag in-between double lined poly bag of the dispensed material seal the outer poly bag.
- On completion of the dispensing, transfer the used scoops in poly bag and transfer to wash area through pass box.
- Transfer the dispensed material to the “Dispensed Material Hold area through PASSBOX and keep the BMR (dispensing& verification of raw material sheets) sheets.
- All the loose drums/bags to be sealed with tamper proof cable ties.
- All loose boxes to be closed with adhesive tape.
- Stores personnel shall enter the quantity against the respective batch/lot numbers, update the issue entry/inventory transfer to production. The acceptable variation limit for all the materials is ±1% on received quantity.
- Switch off the LAF and put the “TO BE CLEANED” status label exit from the area.Record the dispensing booth usage details in the respective log.
- Update the stock details in the stock card.
- REFERENCES:
- Leftover materials in the original pack shall be seal and sent back to the respective storage area, after labelling the container with ‘LOOSE MATERIAL’.
Not Applicable
- ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Warehouse
- Controlled Copy No. 03 : Head Production
- Master Copy : Quality Assurance Department
- ABBREVIATIONS:
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| FIFO | : | First in first out |
| IPQA | : | In process Quality Assurance |
| BMR | : | Batch Manufacturing Record |
| LAF | : | Laminar Air Flow |
| IPA | : | Iso Propyl Alcohol. |
| QA | : | Quality Assurance |
| AHU | : | Air handling unit |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Q: What cleanliness standards are required for the area, equipment, and dispensing tools?
A: The area, equipment, and tools must be clean and free of debris. Separate, clean scoops are needed for each excipient material.
Q: How are empty containers disposed of?
A: Deface the labels and send them to the scrap yard.
Q: How do you verify the balance is calibrated before use?
A: Check the calibration status of the balance by calibration label and calibration log book.
Q: How do you determine which materials and quantities to dispense?
A: Use the provided indent/BMR, considering FIFO (First-In-First-Out) for materials.
Q: How is the material prepared for dispensing?
A: Transfer it to the designated entry area, de-dust if needed, and ensure approved labels are present.
Q: What approvals are needed before starting dispensing?
A: Obtain line clearance from IPQA and verify material details with production & IPQA personnel.
Q: What personal protective equipment (PPE) is required for dispensing?
A: Gowning, goggles, and hand gloves.
Q: How do you ensure safe dispensing within the booth?
A: Use the LAF system and work within the designated safe working zone.
Q: What is the order of material dispensing?
A: Dispense one material at a time according to the BMR, starting with inactive ingredients and then colors/flavors.
Q: How is dispensed material recorded and verified?
A: Record weights in the BMR and on tags, with signatures from both production, IPQA and stores personnel.
Q: How are leftover materials handled?
A: Seal and return them to storage with a “LOOSE MATERIAL” label.
Q: How does stores personnel update inventory after dispensing?
A: Record dispensed quantities, update entries, and ensure acceptable variation limits are met.
Q: What are the post-dispensing housekeeping steps?
A: Turn off LAF, label booth for cleaning, record booth usage, and update stock details.