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This Standard Operating Procedure (SOP) outlines the guidelines for the receipt and storage of raw materials, including Active Pharmaceutical Ingredients – API and Excipients, in the pharmaceutical industry

Receipt and Storage of Raw Materials (API and Excipients)

1.0   Purpose

• • To lay down the procedure for receipt & storage of Raw Materials (API and Excipients).

2.0   Scope

• • This SOP is applicable to the receipt and storage of Raw Materials (API and Excipients) in the drug manufacturing pharmaceutical industry.

3.0   Responsibility

• • Store Personnel:  Receipt and handling of raw Material.

• • Chemist Q.C: Responsible for Sampling and Affixing Under Test, Sampled, Approved and Rejected labels

• • Head Stores: To ensure the Compliance of SOP.

• • Head Q.C: To ensure sampling and affixing Under Test, Sampled, Approved, and Rejected labels.

• • Head QA: Handling of Non-conformity if observed during the receiving of Raw material.

4.0   Procedure for Receipt and Storage of Raw Materials (API and Excipients)

• • After receipt of the information from the security gate, store personnel shall allow the transporter/driver along with delivery documents for verification at the receiving office.

• • After receipt of the delivery document from the transporter/driver through the document receiving window.

• • Store personnel shall verify the documents i.e.

• • • PO details in the electronic system for Item Code / Item Name with Grade

• • • Invoice No. / Challan

• • • Consignee Name & Address

• • • Delivery Address (if any)

• • • Qty. as per PO

• • • Lorry Receipt

• • • COA

• • • E-Way Bill

• • • Supplier / Manufacturer details as per Approved Vendor List

• • • Manufacturing Date

• • • Expiry Date / Retest Date / Best Before Date / Use Before Date / Shelf Life / Re-Evaluation Date / Use By Date etc.

• • After verification of delivery documents, if the delivery documents are found OK then store personnel shall return the delivery documents to the transporter/driver for security gate entry stamping done by a security person and allow the vehicle at the respective receiving bay.

• • When the vehicle arrives at the respective receiving bay, store personnel shall inspect the vehicle as per Annexure II.

• • If the vehicle is found OK documents are found as per Annexure-II, store personnel shall unload the material on clean pallets batch-wise with the help of unloading personnel.

• • Store personnel shall check the physical condition of each container i.e. cleanliness/intactness, Proper Status Labeling by Supplier / Manufacturer.

• • Details of Manufacturer Name / Address shall be verified through Manufacturer COA, Container & Approved Vendor List.

• • If any discrepancy is observed during physical verification of the manufacturer name & address be informed to the purchase & QA department.

• • Store personnel shall verify the proper labeling of each container for details of the Manufacturer i.e.

    • Item Name and Pharmacopoeia Grade

• • • Batch No. / Lot No.

• • • Manufacturing Date

• • • Expiry Date / Best Before Date / Use Before Date / Shelf Life / Re-Evaluation Date / Use By Date and

• • • Storage condition of container etc.

• • If the consignment is OK as per Annexure-II, give the acknowledgment by putting the stamp in the front of the challan / LR copy to the transporter.

• • If discrepancies are found during the verification of the vehicle/documents or the physical condition of the material, Store personnel shall inform to QA and Purchase department.

• • After reviewing the same, the Head QA / Designee shall decide on accepting or returning material.

• • In case the manufacturing date is not available, then store personnel shall inform to QA & Purchase department for rectification or corrective action till the material is held.

• • If the outer seal is broken, Quality Assurance shall inspect the container, and inner seal and if found correct, the material shall be accepted.

• • But if both the seals are found broken, then the Consignment shall be returned to the supplier with information to purchase.

• • If the container is found damaged and the material found exposed to the atmosphere, it shall be Received in the Plant / Returned to the Manufacturer or supplier as per QA advice.

• • Receipt damaged container shall be returned to the Manufacturer or Supplier after rejection by QC.

• • If the MS drum is found with a sharp dent, it shall not be accepted and shall be returned to the manufacturer/supplier with information to Quality Assurance.

• • After unloading of material, store personnel shall switch ON the Air Curtain, open the shutter, and take the material inside the de-dusting area.

• • Store personnel shall take the Long Apron from the SS Cabinet and wear it before de-dusting of receipt consignment with lint-free cloth or vacuum cleaner (if required) in the de-dusting area.

• • Remove the tertiary packing used, if any.

• • If required, use a wet lint-free cloth to clean HDPE / MS drums and immediately shift the received consignment to the quarantine area after cleaning.

• • After de-dusting store personnel shall remove the Long Apron and put it in the used garments waste bin before transferring the de-dusted consignment to the Quarantine Area.

• • If the material with more than one batch/lot is received, these containers shall be placed batch-wise / lot-wise.

• • Store personnel shall perform the gross weight verification. For Active materials, each container shall be weighed on the appropriate calibrated balance and shall be recorded in Annexure-III.

• • Write the gross weight on the container that is observed and write it to the container/pack.

• • If the difference in weight is more than 0.25 % of the container observed then the actual observed weight shall be recorded in the system.

• • Store personnel shall write the date of receiving of the material and container number on front side of the container. eg. If you receive 5 containers then write as 1/5, 2/5, 3/5, 4/5, and 5/5. Also write.
  • In case of excipients, store personnel shall verify the weight of √the n+1 container i.e

• • Store the raw material as per the designed storage condition following the approved vendor list

• • Material required in appropriate storage condition shall be stored at their designated place as given below:

• • • In – Inflammable Solvent:   Store in the in-flammable area

• • • EHG Shells:    Store in the EHG Shells area

• • • Vit.D3: Store in Deep Freeze (2°C – 8°C)

• • • Other material:    As per the designed storage area.

• • If the consignment is accepted inside the stores and because of a pending decision from QA it has not been entered in the electronic system, such material shall be stored in the segregated area, by putting the label “Pending for GRN”.

• • After weight verification of the material, store personnel shall prepare the GRN in an electronic system and print the GRN.

• • During the preparation of GRN, store personnel shall enter Best Before Date / Use Before Date / Shelf Life / Re-Evaluation Date / Use By Date under the Retest Date column.

• • Weight verification of solvent drums shall be done on a 500 Kg Capacity Weighing Balance placed inside the Stores.

• • After weight verification of solvent drums, store personnel shall immediately shift the solvent drums to the Solvent Storage Area.

• • Weight verification of sugar bags shall be done on weighing balance placed at RM Quarantine Area.

• • Send duly checked and signed copies of GRN & COA of Raw material (API and Excipients) to the Quality Control Department for sampling of raw materials (API and Excipients).

• • Store personnel shall print White “Quarantine” labels for the total number of packs/containers and affix them on each pack/container/box at the right side of the original party label without defacing the manufacturer label.

• • On bags status label shall be affixed anywhere but the status label should be visible.

• • The existing approved / Under Test or other status labels except the Product Label shall be crossed with a marker pen before affixing the “UNDER TEST” label.

• • After receipt of GRN, the QC Chemist shall print a yellow-colored “UNDER TEST” label and affix it to each container before taking the materials to the Sampling Area for sampling.

• • The “UNDER TEST” label shall be affixed right/below to “QUARANTINE” label.

• • After sampling, the QC Chemist shall affix a duly filled and signed “SAMPLED” label on the containers from which the sample is drawn, to the right side of the “UNDER TEST” label.

• • After sampling place the consignment to the under test area of the designed under test area.

• • After analysis of API and Excipients, the QC chemist shall follow the given below procedure:

• • Approval of API and Excipients:

• • If the material (API and Excipients) is approved then the Q.C. chemist shall affix a green colored “Approved” label on the “Under Test” label of each container in such a manner that only “Under Test” is hidden by the Approved Label.

• • After approval store personnel shall transfer the material (API and Excipients) to the respective approved area.

• • Approved material (API and Excipients) shall be stored on a rack /Pallets A.R. Number wise and status board shall be maintained.

• • If required material shall be segregated using the physical separator.

• • Rejection of API and Excipients:

• • If the material is rejected then the QC chemist shall affix a red colored “Rejected “ label on the “Under Test” labels of each container in such a manner that only “Under Test” is hidden by the next label.

• • Store personnel shall shift the rejected raw material (API and Excipients) to the Rejected Room in the presence of QA and handle the material as per the direction of the Purchase Department / Head QA.

• • All rejected material shall be returned to the Supplier / Manufacturer or shall be destroyed consent of the vendor within Two Months.

• • Store personnel shall make an entry in the Rejected Log Book, placed in the rejected material room.

• • Note:

• • Wherever supplier’s approved labels are pasted on the front of packs/containers, the QC Chemist shall deface it by cross mark.

• • Record the temperature & humidity if required of the storage area as per SOP No.QA- 020.

• • If there is a printing problem or network issue then fill in the details on Quarantine /under test/Approved/Rejected labels using a ball pen (blue ink) and affix the label on the Bags/containers & packs.

• • In case of code conversion, the above procedure shall be followed. In case of loose transfer material (API and Excipients), details shall be affixed on the container as Manufacturer Name, Item Name, B. No., Mfg. Date, Exp. Date & Quantity etc.

• • In case there is not sufficient space in the under-test/ quarantine area to place the under-test materials / Quarantine Materials, then the materials shall be stored in a specified space.

• • Yellow-coloured chain/tape shall be used to identify this consignment. Yellow-colored chain/tape shall be removed before affixing the next label.

• • Manufacturing Date / Expiry Date / Retest Date / Best Before Date / Use Before Date / Shelf Life / Re-Evaluation Date / Use By Date written as Month & Year on container / COA shall be entered as DD-MM-YYYY format in the electronic system as well as in related documents.

• • Movement of Inflammable Solvents:

• • For sampling / dispensing, shift the solvent drum through outside trolley from Solvent Storage Area to Solvent Sampling / Dispensing Area upto outer side of Red Color Line.

• • Take the solvent drum inside the Red Color Line to perform the sampling / dispensing activity through inside trolley.

• • After sampling / dispensing activity performed inside the area, shift the solvent drum upto inner side of Red Color Line through inside trolley.

• • Shift the solvent drum to Solvent Storage Area through outside trolley.

5.0   Annexure (s) – API and Excipients 

Annexure – I: Flow Diagram of Receipt, Storage, Identification, and Movement of Raw Materials (API and Excipients) in Stores.

Annexure – II: Check List for Raw Material (API and Excipients) Receiving and vehicle inspection

Annexure – III : Weight Verification of Raw Materials (API and Excipient) 

Remarks:……………………………………………………………………………………………………………