1.0 PURPOSE:
2.0 SCOPE:
This procedure for dispensing of raw materials is applicable in warehouse department (Company name).
3.0 DEFINITIONS:
Nil.
4.0 RESPONSIBILITY:
4.1 Warehouse personnel are responsible for dispensing and issuance of active raw materials to user department as per request.
4.2 Quality Assurance and Production personnel are responsible for verification of the activity.
4.3 Head-Warehouse / Designee are responsible for compliance of this SOP.
5.0 PROCEDURE:
5.1 On receipt of BMR / Process Order / Material Indent Cum Issue Note for manufacturing of a product or for testing / sample purpose from user department, warehouse personnel shall check for approved stock of materials from SAP.
5.2 Warehouse person shall identify the approved materials for dispensing on the basis of FEFO followed by FIFO.
5.3 Warehouse person shall arrange materials for dispensing.
5.4 Warehouse person shall check material details like material code, material description, A. R. No., retest date, expiry date etc.
5.5 Loose material containers shall be taken first for dispensing followed by intact containers.
5.6 Wherever applicable warehouse personnel shall calculate the quantity of material to be dispensed based on the Assay and LOD or water content values provided on the COA of particular material.
5.7 Production and Quality Assurance personnel shall verify the calculations.
5.8 Dispensing activity shall be done by the warehouse person and checked by production and QA person.
5.9 Dispensing Procedure:
5.9.1 Dispensing of Active Materials:
5.9.1.1 Ensure that the area cleanliness, area environment conditions, isolator parameters are within the limit.
5.9.1.2 Enter the area conditions on line clearance pages of BMR and sign it by warehouse person.
5.9.1.3 Production and QA person shall verify the area and environmental conditions of the area and gives line clearance by signing on line clearance pages of BMR.
5.9.1.4 Arrange the cleaned scoops / spatula / spoon, polybags etc. for dispensing activity.
5.9.1.5 Arrange Active materials for dispensing inside the isolator.
5.9.1.6 Wherever required attach SS bins or hicoflex bag to the isolator with the help of SBV or passive valve.
5.9.1.7 Place double poly bag / container in which the material has to be dispensed on weighing balance.
5.9.1.8 Note down tare weight and press the tare key on weighing balance and make the reading “zero”.
5.9.1.9 Transfers the material from its original bags with a scoop / spatula / spoon into poly bag / container as per quantity mentioned in BMR / Process Order / Material indent cum issue note and record the net weight.
5.9.1.10 Press gross weight key on weighing balance for knowing the gross weight of the container / poly bag.
5.9.1.11 Close the outer polybag of dispensed material with the help of cable tie and transfer dispensed material bag to pass box chamber of isolator.
5.9.1.12 At the time of bag closing ensure that maximum amount of trapped air should be removed.
5.9.1.13 If required nitrogen purging should be done.
5.9.1.14 Record the product and material details, gross weight, tare weight and net weight in “Dispensed Material Tag” and in BMR and sign it by warehouse, production and QA person.
5.9.1.15 Put “Dispensed Material Tag” in between the two polybags and tie outer polybag with cable tie.
5.9.1.16 Enter the product and material details on weight printout and affix it to BMR.
5.9.1.17 The dispensed material then can be transferred to SS bin or hicoflex bag as per the requirement.
5.9.1.18 If any API which has storage condition of 2°C to 8°C or below 2°C, shall be dispensed as and when required.
5.9.1.19 In case of the materials which require 2°C to 8°C or below 2°C storage condition, after dispensing if material is not required immediately for production, then dispensed material shall be stored under cold chamber at 2°C to 8°C or in deep freezer below 2°C till it is required for production.
5.9.1.20 In case the user department requests for any specific A.R. No. / Quarantine material, user department shall raise a “Request for conditional issuance of Material”.
5.9.1.21 User department shall take the signatures of all concerns and handover the dully signed “Request for conditional issuance of Material” to warehouse along with approved process order or material indent cum issue note.
5.9.1.22 Affix “Loose” label to the container from which material dispensed.
5.9.1.23 After completion of dispensing activity enter the details in “Area Usage and Cleaning Record”.
5.9.2 Dispensing of Excipients:
5.9.2.1 Ensure that the area cleanliness, area environment conditions, RLAF magnehelic gauge readings are within the limit.
5.9.2.2 Enter the area conditions on line clearance pages of the BMR and sign it by warehouse person.
5.9.2.3 Production and QA person shall verify the area and environmental conditions of the area and gives line clearance by signing on line clearance pages of BMR.
5.9.2.4 Arrange excipient material for dispensing under RLAF.
5.9.2.5 Dispense the excipient materials by following the steps from 5.9.1.7 to 5.9.1.12.
5.9.2.6 Dispense the solvents as per the requirement given in BMR or Material Indent Cum Issue Note by weighing or by measuring with the help of measuring cylinder or by pipettes with the help of pipette controller.
5.9.2.7 After completion of dispensing activity close the remaining material bags.
5.9.2.8 Close the dispensed material inner poly bags.
5.9.2.9 At the time of bag closing ensure that maximum amount of trapped air should be removed.
5.9.2.10 If required nitrogen purging should be done.
5.9.2.11 Record the product and material details, gross weight, tare weight and net weight in “Dispensed Material Tag” and in BMR and sign it by warehouse, production and QA person.
5.9.2.12 Put “Dispensed Material Tag” in between the two polybags and tie the outer polybag with cable tie.
5.9.2.13 Enter the product and material details on weight printout and affix it to BMR.
5.9.2.14 If any material which has storage condition of 2°C to 8°C or below 2°C, shall be dispensed as and when required.
5.9.2.15 In case of the materials which require 2°C to 8°C or below 2°C storage condition, after dispensing if material is not required immediately for production, then dispensed material shall be stored under cold chamber at 2°C to 8°C or in deep freezer below2°C till it is required for production.
5.9.2.16 In case the user department requests for any specific A.R. No. / Quarantine material, user department shall raise a “Request for conditional issuance of Material”.
5.9.2.17 User department shall take the signatures of all concerns and handover the dully signed “Request for conditional issuance of Material” to warehouse along with approved process order or material indent cum issue note.
Note:
1. In case of excipient material dispensing, if any material needs to be weigh below operating range of available balances, same shall be dispensed on the appropriate weighing balance available in Excipient Sampling area.
2. Details of the weighing balance used shall be record in respective BMR and relative area document shall be updated.
5.9.2.18 Affix “Loose” label to the container from which material dispensed.
5.9.2.19 After completion of dispensing activity enter the details in “Area Usage and Cleaning Record”.
6.0 ABBREVIATIONS:
6.1 BMR – Batch Manufacturing Record
6.2 FEFO – First Expiry First Out
6.3 FIFO – First In First Out
6.4 A.R. No. – Analytical Reference Number
6.5 LOD – Loss on drying
6.6 COA – Certificate of Analysis
6.7 SBV – Split Butterfly Valve
6.8 API – Active Pharmaceutical Ingredients
6.9 RLAF – Reverse Laminas Air Flow
7.0 REFERENCES:
Nil.
8.0 LIST OF ANNEXURES:
Nil.
Also read: SOP for dispensing of packaging materials.
Also read: SOP for handling of raw material spillage
2 thoughts on “SOP for dispensing of raw materials”
when will performed cleaning activity & which type of cleaning shall be performed after dispensing of API & Excipients.
Please share cleaning procedure if possible
Dear Harsh,
Type ‘B’ cleaning may be performed in between dispensing of excipients and API. Please go through the “SOP for operation and cleaning of dispensing booth and accessories”.