SOP Title: Dispensing Of Raw Materials
- Objective:
To lay down the procedure for Dispensing of Raw Materials in the Warehouse .
- Scope:
This SOP is applicable for dispensing of raw materials, operating and cleaning of Dispensing Booth in the Warehouse.
- Responsibility:
- Warehouse: To prepare and review the SOP. To follow the procedures laid down for dispensing of Raw materials, operating and cleaning the Dispensing Booth.
- Production Department: To share a copy of the Bill of Materials (BOM) to
Warehouse Department one day in advance
- Quality Assurance Department: To review and approve the SOP and Annexure
- Engineering Department: To follow the procedures laid down as per SOP
- Accountability:
Head, Warehouse and Head Quality Assurance
- Procedure:
- Definitions:
- Raw Materials: As per this scope of SOP, Raw material are defined as Active Pharmaceutical Ingredients, Excipients, Coating materials, empty hard gelatin shells and likewise.
- Dispensing tools: As per scope of this SOP, dispensing tools are bowls, scoops, containers, spatulas, and likewise of SS 316 make.
- First in First Out: A chronological sequence for selecting the Raw Materials for dispensing i.e., material received on earlier date is selected first followed by raw material on later date.
- Disinfectant solution: Prepared by addition of 2.5mL of Savlon in 100mL of purified water. To be prepared and used freshly and not to be stored.
- Procedure:
- Definitions:
| 5.2.1 | Receive the BMR containing the BOM and Line Clearance pages from the production department. Confirm the presence of calculation sheet as required. | |
| 5.2.2 | Before starting operation ensure the following checks
a. Cleanliness status label of the area b. Temperature and humidity compliance c. Vessels to be used are labelled clean d. Cleanliness status label of the LAF e. Calibration and Preventive Maintenance status of the LAF f. Status board entry |
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| 5.2.3 | Perform the API dispensing calculation as recommended in Calculation sheet. Verify the calculation. | |
| 5.2.4 | Collect the required drums or containers of the raw materials from the respective racks and place in the designated area near the receiving pass box.
Note: Materials with shorter expiry are preferred for dispensing or follow the First in First Out sequence |
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| 5.2.5 | Collect the required cleaned vessels, polybags, labels, tags and likewise as needed for the dispensing activity and place in the designated area near the receiving pass box. | |
| 5.2.6 | Before starting the operation ensure for line clearance and record in the BMR. Record the activity in Annexure. | |
| 5.2.7 | Enter the dispensing booth wearing secondary gowning. | |
| 5.2.8 | Switch on the UV of pass box and wait for not less than 15 minutes prior to passing materials through the pass box. | |
| 5.2.9 | Ensure that the differential pressure is between 1 – 4 mm of water before RLAF is switched on. | |
| 5.2.10 | Ensure that the manometer reading across the HEPA filter is
0 mm WG when the RLAF unit is switched ‘OFF’. |
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| 5.2.11 | Switch ‘ON’ the incoming power supply to the RLAF unit from the main switch board. | |
| 5.2.12 | Switch ‘ON’ the Light and the blower of RLAF to start the RLAF Unit. | |
| 5.2.13 | Ensure that the Manometer reading across the HEPA filter is between 08 mm to 20 mm of WG when RLAF is switched ‘ON’. | |
| 5.2.14 | Ensure that the direction of the air flow is not blocked due to the equipment or the movement of the persons during the Dispensing activity. | |
| 5.2.15 | Ensure that all the balances are calibrated before start of the dispensing activity. | |
| 5.2.16 | Ensure that the Temperature and Humidity records are within the limit as mentioned in the BMR. | |
| 5.2.17 | Before start ensure that the Warehouse associate involved in dispensing wears proper PPE as per product requirement. | |
| 5.2.18 | The materials to be dispensed are to be brought inside the dispensing booth through the pass box | |
| 5.2.19 | Re-check the Materials with the BOM mentioned in the BMR before opening the container. | |
| 5.2.20 | If all the materials are found okay then start the dispensing as per BOM of respective BMR. | |
| 5.2.21 | Dispense all the excipients first, followed by Active Pharmaceutical Ingredients, followed by coating materials, followed by coloured materials and followed by liquids. | |
| 5.3 | Dispensing of solid raw materials | |
| 5.3.1 | Take two clean polyethylene bags keep on Electronic weighing balance and take Tare weight by pressing ‘Tare’ button. | |
| 5.3.2 | Remove the poly bag from the balance and reconfirm the tare weight. | |
| 5.3.3 | Dispense the Raw material as per requirement using clean dispensing tools. Record the activity balance log book. | |
| 5.3.4 | Once dispensed, seal the original bags container properly. | |
| 5.3.5 | Prepare the label as per Annexure and place it between the two polybags of dispensed material. Secure the polybags with nylon tags. | |
| 5.3.6 | If more than one set of ploy bags are used for dispensing the same material then number of polybags used should be mentioned in the label. Example, 1 of 2 and 2 of 2 and likewise | |
| 5.3.7 | After labelling and sealing keep the polybag in the dispensed material pass box. | |
| 5.4 | Dispensing of liquid raw materials | |
| 5.4.1 | Take a clean SS drum and keep on Electronic weighing balance and take Tare weight by pressing ‘Tare’ button. | |
| 5.4.2 | Remove the SS drum from the balance and reconfirm the tare weight. | |
| 5.4.3 | Dispense the liquid raw material as per requirement using clean dispensing tools. Record the activity balance log book.
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| 5.4.4 | Once dispensed, seal the original liquid container properly. | |
| 5.4.5 | Prepare the label as per Annexure and place it on the outer surface of the SS container and secure it with a proper SS lid. | |
| 5.4.6 | Transfer the SS drums with the dispensed liquids in the dispensed material pass box. | |
| 5.5 | Recording of dispensing activities | |
| 5.5.1 | Once all the solid and liquid raw material is dispensed, Label the container as per Annexure and transfer it to the production area. | |
| 5.5.2 | Record all the dispensing data in respective BMR and hand over to the production department. | |
| 5.5.3 | Record the activity in Annexure | |
| 5.5.4 | After completion of the dispensing activity, switch off the light, blower and power supply of the RLAF unit. Mention on the status board as “To be Cleaned”. | |
| 5.6 | Cleaning of dispensing tools | |
| 5.6.1 | All the dispensing tools used for dispensing should be covered with polybag and label it is ‘To be cleaned’. | |
| 5.6.2 | Transfer the above tools through a SS Container to the washing area of the production department. | |
| 5.6.3 | Wash the dispensing tools with potable water till no trace of powder is observed sticking to the tools. | |
| 5.6.4 | Clean the tools using 2.5 % soap solution by rubbing with nylon brush. | |
| 5.6.5 | Finally rinse the utensils with Purified water, dry it and wrap the tools with a clean poly bag and label it as “Cleaned” . | |
| 5.6.6 | Store the cleaned dispensing tools in the designated SS cupboard. | |
| 5.7 | Cleaning of dispensing area | |
| 5.7.1 | Remove any threads, seals, polybags present in the dispensing area. | |
| 5.7.2 | Clean the floor area and dispensing booth with vacuum cleaner | |
| 5.7.3 | Clean the dispensing tables, supply air grill, return air grill cover with clean cloth moistened with purified water. | |
| 5.7.4 | Mop the floor area of dispensing booth with disinfectant solution. (i.e. 2.5% v/v Savlon) Record the activity in Annexure . | |
| 5.8 | Cleaning of RLAF | |
| 5.8.1 | RLAF filters should be cleaned for every product change over. | |
| 5.8.2 | Clean the filters RLAF every fortnight or if the filters are chocked up and the manometer readings across the HEPA filters are not within the prescribed limit. | |
| 5.8.3 | Switch off the RLAF from the mains and remove the grills of the pre-filter and the fine filter from the RLAF with the help of screw driver. | |
| 5.8.4 | Remove the pre-filters and fine filter with the help of spanner and place the filters in polybag. | |
| 5.8.5 | Affix status label ‘To be cleaned’ and handover the filters to Engineering department for cleaning. | |
| 5.8.6 | Clean the filter chamber and RLAF from inside with the help of vacuum cleaner and wipe with wet lint free duster followed by dry duster. | |
| 5.8.7 | Collect the cleaned pre-filters and fine filter from Engineering department. | |
| 5.8.8 | Fit the cleaned pre-filters and fine filter in the RLAF Affix status label as ‘Cleaned’. | |
| 5.9 | Breakdown | |
| 5.9.1 | If breakdown occurs during dispensing, hold the material in closed condition. Inform to the Head Warehouse. | |
| 5.9.2 | Fill the “Breakdown Intimation Form” and submit to Engineering Department. | |
| 5.9.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.9.4 | Remove, label and segregate the material properly if required for breakdown rectification. | |
| 5.9.5 | If breakdown occurs prior to start of operation, follow step 5.9.2. | |
| 5.9.6 | Record the breakdown activity in Usage log for Dispensing Booth. | |
| 5.9.7 | After completion of repairs, the dispensing can be resumed. Perform cleaning as per 5.6 or 5.7 or 5.8 as applicable, prior to start of dispensing. | |
| 5.9.8 | Collect and file a copy of the “Breakdown Intimation Form” certifying that the repair works have been successfully completed. | |
| 5.9.9 | Record the repair completion activity in Usage log for Dispensing Booth. | |
| 5.9.10 | Describe the breakdown activity in the respective product BMR. | |
| 5.10 | Preventive Maintenance | |
| 5.10.1 | Perform the preventive maintenance as per Annexure. | |
| 5.10.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.10.3 | Attach the preventive maintenance label. | |
| 5.11 | Calibration | |
| 5.11.1 | Perform the calibration of RLAF as per SOP. | |
| 5.11.2 | If calibration activity is outsourced, the values are to be transcribed, and external party certificate to be attached. | |
| 5.11.3 | Affix the calibration label. |
- Abbreviation
| Abbreviation | Expansion |
| PPE | Personal Protective Equipment |
| HOD | Head of Department |
| BOM | Bill Of Materials |
| RLAF | Reverse Laminar Air Flow |
| WH | Warehouse Department |
| WG | Water Gauge |
| 0C | Degree Celsius |
| API | Active Pharmaceutical Ingredient |
| HEPA | High Efficiency Particulate Air |
| ml | Millilitre |
| SS | Stainless Steel |
| BMR | Batch Manufacturing Record |
| mm | Millimetre |
| % | Percentage |
| v/v | Volume by volume |
*Note – Ready to use SOP available in “DOWNLOAD” Section.