1.0 Purpose : To define the procedure for dispensing of raw materials
2.0 Objective : To provide guidelines for dispensing of raw materials.
.
3.0 Scope : This procedure applies to dispensing of raw materials in stores
Department
4.0 Responsibility :
· Follow up : Officer – Stores
· Over all responsibility: Store Incharge.
5.0 Procedure :
· Stores Officer
Ø Receive the raw material issue requisition and record the serial number, material code and date of receipt. Check for the entries in all the columns viz. Dept, Batch Size., Batch No. and signatures for requisite by and authorizes by. If any of these columns is missing, return the requisition to production.
Ø From the raw material stock register, check the quantities of material available and quantities requested for. If any of the material in stock is less than the requisitioned
Quantity, inform to Stores Incharge.
· Stores Incharge.
Ø Check the materials in “Under Test” status. If the material requisitioned is
present in “Under Test” status, inform the Manager – Production and Asst
Manager – QC regarding the same. Hold the issue of the other materials
till the material is approved by QC.
· Stores Assistant
· Check the dispensing area for the following Cleanliness.
Ø No other material is present in the area
Ø The balance is clean and has been calibrated for the day.
Ø Availability of cleaned dispensing devices (scoops, etc.)
Ø Protective equipment has been worn as per the material safety data sheet.
Ø Check the details of the material on the Approved Label.
o Name of the Material
o Batch No.
o Batch size.
o A.R.No.
o Quantity
o No. of container.
o Tare Wt
o Gross Wt.
o Net Wt.
o Date
o Signature
Ø Check the tare weight of the empty container and note down on the dispensed label.
Ø Select the bulk raw material container of appropriate AR No as per FIFO system. Check the retest date on the label. If the retest date falls in the month of issue, inform QC regarding the retesting.
Ø Transfer the material to the dispensing area. Carefully transfer the material into the container till the quantity required is transferred
Ø Note down the final weight of the container and record on the dispensing label for gross weight.
Ø Calculate the net weight and record on dispensing label and sign for issued by.
Ø Close the bulk raw material container and transfer back the bulk raw material container to the original space.
Ø Repeat the steps for remaining materials of the raw l issue requisition one after the other.
Ø Never keep more than one material in the dispensing area. Transfer the second material only after the first has been dispensed and transferred back to its original space.
Ø Always use clean dispensing devices and do not contaminate one with other material.
Ø Enter the details of issue into the raw material stock register for the material.
Ø Verify the quantities dispensed against the raw material issue requisition and sign for Store officier.
Ø Inform the Asst. Manager – Production / Manager – Production regarding the checking of the material.
Ø material requisition will be made two copy. one copy will be kept in store department and duplicate copy attach with B.M.R.
6.0 Reference documents :
v Material Requisition Note.
v Dispensing activities log book
v Stock Register in Raw Material
MATERIAL REQUISITION NOTE | Sr. No. | |
To: Store Department | From Production Department | |
Kindly issue the following Raw Material as per details given below. | ||
Name of Product: ____________________________________ Stage No.: ______________ | ||
Batch No.: ________________ Batch Size: ________________Kg Mfg. Date: _____________ | ||
Sr. No. | Material Name | Material code | Quantity in Kg/L | Batch No. | A. R. No/Store Ledger Folio | |||
Required | Issued | |||||||
| | | | | | | ||
| | | | | | | ||
Format No.F/ST/009 Material Requisition: | ||||||||
Issued By (Production) | Authorized By (Production) | Received By (Stores) | ||||||
Sign & Date | Sign & Date | Sign & Date | ||||||
Dispensed Material | ||
Dispensed By (Stores) | Checked By (Stores) | Received By (Production) |
Sign & Date | Sign & Date | Sign & Date |
Dispensing activities log book
Format No.F/ST/0010
Date. | Activities | TIME | Product Name | Product Code | B.No/stage ssStage | Batch Size | Dispensed by | Checked by | Remark | ||
From | To | ||||||||||
| | | | | | | | | | ||
| | | | | | | | | | ||
| | | | | | | | | |
Stock Register. :
Content of Stock Register.
Description of goods: Year Month Ecc No: XYYZZX23CN234 Sr. No.
Sr. No , Date of Recipt, GRN No, Q.C.No, Challn No, Invoice No,&Date, Quantity Recived, Name of Manufacture, Issue for production→Chit No Dt.and Quantity, for Batch No, Issued for clearance as such on payment of duty→Invoice No& Date and Quantity, Othervised disposed of →Detail of document and Quantity,
Closing Balance, Closing Month.
Format No.F/ST/011
Thank you for briefing everyone about the significance of quality assuarance and current Good Manufacturing Practices (cGMP) in Pharmaceutical Companies.
ReplyDeleteThank you for briefing everyone about the significance of quality assuarance and current Good Manufacturing Practices (cGMP) in Pharmaceutical Companies.
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