| 1.0 | Purpose: |
| | To describe the procedure for transfer and receipt of bulk (Active Raw material) from the warehouse to the production area (Vaccine Formulation). |
| 2.0 | Applicable: |
| | This Standard Operating Procedure applies to the transfer and receipt of active raw material from the warehouse to the production area in Pharmaceuticals. |
| 3.0 | Responsibility: |
| 3.1 | The line coordinators who are trained in the processes shall carry out the operation process. |
| 3.2 | Officers/ In-charge shall be responsible for supervision of the process. |
| 3.3 | Head Production shall be responsible for implementation of SOP. |
| 3.4 | Head-Quality Assurance shall be responsible for compliance with SOP. |
| 4.0 | Safety Consideration. |
| 4.1 | Bulk bottles shall be handled carefully in their respective containers. |
| 4.2 | ARM in the glass bottles shall be handled carefully with proper material movement. |
| 5.0 | Equipments: |
| 5.1 | Dynamic pass box |
| 5.2 | Static pass box |
| 5.3 | Cold room (2-8 º C ) |
| 5.4 | Deep freeze -20 º C |
| 5.5 | Mobile LAF ( horizontal) |
| 5.6 | LAF (Vertical) |
| 5.7 | Dispensing booth |
| 6.0 | Materials and reagents: |
| 6.1 | 70% sterile Isopropyl alcohol |
| 6.2 | Sterile lint-free mops |
| 7.0 | Preparation of solutions: |
| 7.1 | 70 % IPA Preparation |
| 8.0 | Procedure: |
| 8.1 | As per production requirement, fill up the Batch initiation slip mentioning the bulk details and send it to the warehouse for transfer of bulk in the presence of Q.A. |
| 8.2 | Check and ensure the label details and specification of ARM bulk bottles with the requisition slip, and then the bulk received from the warehouse shall transfer to the dispensing area of the production area for dispensing activity as follows. |
| 8.3 | Check and ensure the label details and specification of ARM bulk bottles with the requisition slip, and then the bulk received from the warehouse shall transfer to dispensing area of the production area for dispensing activity as follows. |
| 8.4 | Procedures for ARM transfer from warehouse to production area. |
| 8.4.1 | Procedure of receiving the ARM for dispensing. |
| — | 8.4.1.1 | After Receiving the ARM bulk container from the static pass box, Clean the outer surfaces of the 1st layer of biohazard polythene with lint-free mops soaked with 70% IPA and remove and discard the 1st polybag covering of the ARM container. |
| — | 8.4.1.2 | Then transfer the ARM container intact with the second biohazard polythene bag on the material transfer trolley and put the container in Dynamic pass Box (SOP). Clean the outer surface of the container with mops wet with 70% IPA. |
| — | 8.4.1.3 | Transfer the ARM container by cleaning the outer surface of the container with mops wet with 70% IPA and transfer it through the dynamic pass box. |
| — | 8.4.1.4 | Clean the outer surface of the container with mops wet with 70% IPA and transfer the bulk container to the Dispensing booth for dispensing activity. |
| — | 8.4.1.5 | Open and remove the second and final biohazard polythene bag from the ARM bulk container under the dispensing booth, Clean the outer surface of the bulk bottle with mops wet with 70% IPA and then carry out the dispensing activity. |
| 8.4.2 | Procedure for transfer of the mother bottle with remaining ARM to the cold room of warehouse after dispensing. |
| | 8.4.2.1 | After completion of the dispensing activity, Cover the ARM containers with double biohazard polythene bags under the dispensing booth. |
| | 8.4.2.2 | After completion of the covering activity, keep the ARM containers on the material transport trolley and transfer them to the room through the dynamic pass box. |
| | 8.4.2.3 | Transfer the mother bottle with the remaining ARM to the cold room of the warehouse by using the pass box. |
| | 8.4.2.4 | Dispensed ARM which needs to be stored below at (-20°C) also to be transferred to the warehouse as per the procedure defined in step number 8.4.2.3. |
| 8.4.3 | Procedure for transfer of the dispensed ARM from dispensing room to formulation area. |
| | 8.4.3.1 | Dispensed ARM for the day use in the formulation is to be transferred to the respective formulation area. |
| | 8.4.3.2 | After completion of the dispensing activity, keep the ARM containers on the material transport trolley and transfer them to the room through the dynamic pass box. |
| | 8.4.3.3 For formulation area |
| | 8.4.3.3.1 | For the formulation area, receive the material in room number 135 through the DPB in room number 138 (via corridor number 037C). Before receiving the material outer surface of the container should be cleaned with mops wet with 70% IPA. |
| | 8.4.3.3.2 | Receive the material in room number 117 through the DPB in room number 117 and transfer the same to formulation room number 120 via room number 114. Before receiving the material outer surface of the container should be cleaned with mops wet with 70% IPA. |
| | 8.4.3.3.3 | Store the ARM bottles in cold room number PR/EQP/CRS11901 till further use in the formulation. |
| | 8.4.3.4 For line -II formulation area |
| | 8.4.3.4.1 | For the formulation area, receive the material through the Dynamic Pass Box (via corridor). Before receiving the material outer surface of the container should be cleaned with mops wet with 70% IPA. |
| | 8.4.3.4.2 | Transfer the same to the formulation room. Before receiving the material outer surface of the container should be cleaned with mops wet with 70% IPA. |
| | 8.4.3.4.3 | Store the ARM bottles in the cold room till further use in the formulation. |
| 9.0 | Annexure: |
| | Not applicable |
| 10.0 | Distribution |
| | Master Copy | Archived with the Quality Assurance Department |
| | controlled Copy | Quality Assurance Department |
| | Subsequent controlled copies | Department (s) making requisition |
