SOP on Transfer and Receipt of bulk (ARM) from Warehouse to Production area

Learn About SOP on Transfer and Receipt of bulk (Active Raw Materials) from the Warehouse to the Production area.

SOP on Transfer & Receipt of bulk (ARM) from Warehouse to Production area
1.0Purpose:
 To describe the procedure for transfer and receipt of bulk (Active Raw material) from the warehouse to the production area (Vaccine Formulation).
2.0Applicable:
 This Standard Operating Procedure applies to the transfer and receipt of active raw material from the warehouse to the production area in Pharmaceuticals.
3.0Responsibility:
3.1The line coordinators who are trained in the processes shall carry out the operation process.
3.2Officers/ In-charge shall be responsible for supervision of the process.
3.3Head Production shall be responsible for implementation of SOP.
3.4Head-Quality Assurance shall be responsible for compliance with SOP.
4.0Safety Consideration.
4.1Bulk bottles shall be handled carefully in their respective containers.
4.2ARM in the glass bottles shall be handled carefully with proper material movement.
5.0Equipments:
5.1Dynamic pass box
5.2Static pass box
5.3Cold room (2-8 º C )
5.4Deep freeze -20 º C
5.5Mobile LAF ( horizontal)
5.6LAF  (Vertical)
5.7Dispensing booth
6.0Materials and reagents:
6.170% sterile Isopropyl alcohol
6.2Sterile lint-free mops
7.0Preparation of solutions:
7.170 % IPA Preparation
8.0Procedure:
8.1As 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.
8.2Check 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.
8.3Check 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.
8.4Procedures for ARM transfer from warehouse to production area.
8.4.1Procedure of receiving the ARM for dispensing.
 —8.4.1.1After 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.
 —8.4.1.2Then 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.
 —8.4.1.3Transfer 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.
 —8.4.1.4Clean the outer surface of the container with mops wet with 70% IPA and transfer the bulk container to the Dispensing booth for dispensing activity.
 —8.4.1.5Open 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.
8.4.2Procedure for transfer of the mother bottle with remaining ARM to the cold room of warehouse after dispensing.
 8.4.2.1After completion of the dispensing activity, Cover the ARM containers with double biohazard polythene bags under the dispensing booth.
 8.4.2.2After 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.
 8.4.2.3Transfer the mother bottle with the remaining ARM to the cold room of the warehouse by using the pass box.
 8.4.2.4Dispensed 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.
8.4.3Procedure for transfer of the dispensed ARM from dispensing room to formulation area.
 8.4.3.1Dispensed ARM for the day use in the formulation is to be transferred to the respective formulation area.
 8.4.3.2After 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
 8.4.3.3.1For 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. 
 8.4.3.3.2Receive 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.
 8.4.3.3.3Store 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
 8.4.3.4.1For 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.
 8.4.3.4.2Transfer the same to the formulation room. Before receiving the material outer surface of the container should be cleaned with mops wet with 70% IPA.
 8.4.3.4.3Store the ARM bottles in the cold room till further use in the formulation.
9.0Annexure:
 Not applicable       
10.0Distribution
 Master CopyArchived with the Quality Assurance Department
 controlled CopyQuality Assurance Department
 Subsequent controlled copiesDepartment (s) making requisition
11.0History:
 —Effective DateStatusChanges/Reasons for Revision
 —Mention DateRevision No: 00New SOP
 —Mention DateRevision No: 01Changes/Reasons for Revision
 —Mention DateRevision No: 02Changes/Reasons for Revision
12.0Abbreviations:
12.1HOD: Head of the Department
12.2ID No: Identification number
12.3No. : Number
12.4QA: Quality Assurance
12.5SOP: Standard Operating Procedure
12.6IPA: Isopropyl alcohol
12.7ARM: Active raw material
12.8DPB: Dynamic pass box
12.9SDB: Static pass box
Written by
Name and DesignationSignatureDate ( DD/MM/YY)
Reviewed by
Name and DesignationSignatureDate ( DD/MM/YY)
Departmental Approval
Name and DesignationSignatureDate ( DD/MM/YY)
QA Authorization
Name and DesignationSignatureDate ( DD/M.M/YY)

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