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sop for Receipt and Storage of Raw Materials

 

sop for Receipt and Storage of Raw Materials

 

1.0 Objective
To lay down a procedure for receipt and storage of raw materials.
2.0 Scope
This Standard Operating Procedure is applicable for receipt and storage of raw materials to

be followed at formulation plants of A B C Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive warehouse shall be responsible for receipt and storage of raw material.
3.2 Head Warehouse shall be responsible for implementation of this SOP.
3.3 Head QA or his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
No. : Number
QA : Quality Assurance
WH : Warehouse
HOD : Head of Department
5.0 Procedure
5.1 Security shall inform to warehouse personnel about the receipt of material with delivery documents.
5.2 Stores Officer / Executive shall verify party’s delivery challan, COA, entry stamped by Security

and ensure that the vendor/ supplier must be as per approved vendor list.
5.3 Incase of Narcotics Drugs Store Officer / Executive shall verify the documents with excise department.
5.4 Store Officer / Executive shall ensure that all incoming consignment documents should bear the purchase order

number. Also check the documents of consignment for the followings as per Annexure-1.
5.4.1 Consignor and consignee name
5.4.2 Approved vendor as per approved vendor list
5.4.3 L R Copies i.e. (Consignee Copy & Driver Copy)
5.4.4 Freight Charges i.e. (To Pay or Paid or TBB)
5.4.5 Delivery Challan
5.4.6 Duplicate for transporter copy i.e. Cenvat Copy of Invoice
5.4.7 Certificate of Analysis
5.4.8 Road Permit if Applicable
5.4.9 Security Inward
5.5 At a time, only one vehicle shall be allowed to enter inside the factory. The vehicle shall

be aligned with the receiving bay of respective block.
5.6 Before opening the shutter stores officer must be “Switch ON” the air curtain.
5.7 Before unloading check the physical conditions of the vehicle used for transport with respect

to cleanliness as per Annexure-1.
5.8 Warehouse Staff ensure the Fly-O-Cide of the area “ON” all the time.
5.9 Ensure the inside door and main shutter are not opened at the same time.
5.10 Warehouse Officer / Executive shall ensure that the material shall be unloaded on clean pallets

lot wise, material wise, Invoice Wise (if any) and Party Approved label is deface.
5.11 At the time of unloading Warehouse Officer/Executive shall check the consignment.
5.11.1 Drums/Containers Packing Seal
5.11.2 Container Label.
5.11.3 Material Physical Condition
5.11.4 Material Name:
5.11.5 Batch No.:
5.11.6 Mfg Date:
5.11.7  Exp. Date / Re-Test Date / Re-Valuation Date / Re-Certification Date/ Best Before Date/ Use Before Date
5.11.8  Name of Manufacturer
5.11.9 Name of the Supplier.
5.11.10 Pharmacopeias Status
5.11.11 Storage Condition
5.12 Incase containers label is not legible or tear during transportation warehouse person shall make the labels as per

documents / COA after approval from QA Department and paste the label in presence of IPQA person.
5.13 After Checking the consignment Warehouse Officer / Executive shall verify the consignment as

per RM/PM Receipt Check List (Annexure-1).
5.14 The observations pertaining to the receipt of the material shall be recorded in the enclosed

format of “RM/PM Receipt Check List” (Annexure-1). Discrepancy shall be reported to Q.A.
5.15 The material and the pallet (on which it is stacked) shall be cleaned by using vacuum Cleaner followed

by wiping with dry clean duster as per SOP No. BBL/WH/SOP/007. Ensure that Air Curtain is “ON” and inside

door is closed while cleaning the material.
5.16 The consignment shall be checked for any damage or discrepancy in weight:
5.16.1 Critical defects-he inner container/ poly bag is damaged there by exposing the material.
5.16.2 Major defects-Outer container is deformed/ de-shaped.
5.16.3 Minor defects- Containers with dent surface appearance.
5.17 If the damage is of
Category-I: Return the material back to the supplier.
Category-II: Receive and separate the container, and Re-Pack as per advice of QA.
Category-III: Make the note on the challan and inform the supplier about the discrepancy not to recur.
5.18 The receipt shall be acknowledged by signing the delivery challan and a copy of the same shall be given to the

transporter with a remark (if any discrepancy is found).
5.19 Weigh all the containers/Bags of API and  √n+1 rolls for Excipients and observations shall be

recorded in “RM / PM Receipt Check List” (Annexure –1).
5.20 At the time if receipt, if only a part quantity of the consignment is found damaged following action shall be taken.
5.21 If the consignment is covered under Excise duty, then receipt of the full consignment shall be taken

and the quantity of damaged and exposed consignment shall be rejected by Q.C. and Rejected

quantity shall be informed to Purchase department.
5.22 If the consignment is without Excise duty, then good quantity of that consignment shall be accepted

and Remarks shall be made on the Vendor’s challan, and intimated to QA and Purchase

by E-Mail about the consignment.
5.23 If the Quantity of the consignment tallies with the delivery challan, the containers shall then

be transferred to respective “Day’s Store”.
5.24 The details receipt shall be entered in “Goods Receipt Note” in MRP Software.
5.25 Warehouse Officer / Executive shall print the “Quarantine Label”, from the computer, as shown in Annexure-2.
5.26 ‘Quarantine’ Label shall be affixed on each container/ Bag of the consignment.
5.27 Material shall be then transferred to “Quarantine Area”.
5.28 Warehouse Officer/ Executive shall inform QC by sending “Goods Receipt Note” for sampling.
5.29 After sampling from the consignment Q.C. Officer shall sample and paste ‘Under Test Label’

and “Sampled” on the containers.
5.30 Material shall be then transferred to “Under Test Area”.
5.31 After analysis, Q.C. Officer shall affix either “Approved” or “Rejected” label.
5.32 The approved material shall be transferred to Approved designated racks and maintain the

Material Location Chart. This chart shall be updated as and when new materials are kept in the racks.
5.33 In case of bulky items like Sugar etc, fence the material with ribbon as per status,

like For Quarantine- Blue Ribbon, Under Test- Yellow Ribbon, Approved-Green Ribbon and Rejected- Red Ribbon.
5.34 For Solvent and Liquid material shall be in “Solvent Store Room”.
5.35 The Rejected goods shall be stored in Reject Area under intimation to Purchase Department.
6.0 Forms and Records
6.1 RM / PM Receipt Check List – Annexure-1
6.2 Quarantine Label – Annexure-2
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Warehouse Department.

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sop for Receipt and Storage of Raw Materials

 

 

 

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