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Standard Operating Procedure (SOP) for Raw Material Reconciliation in the warehouse/store department in pharmaceuticals to maintain the stock of raw material. 

Procedure for Raw Material Reconciliation

1.0   PURPOSE:

• • The purpose of this SOP is to define the procedure for raw material reconciliation.

2.0   SCOPE:

• • This procedure is applicable to all raw materials for verification of physical stock at the warehouse/stores department in the pharmaceutical drug manufacturing plant.

3.0   REFERENCES:

• • In-house

4.0   RESPONSIBILITIES:

• • Warehouse personnel shall be responsible for carrying out raw material reconciliation as per procedure and investigate the discrepancy details if found out of the specified limit.

• • Warehouse Head or Designee shall be responsible for the proper implementation of SOP.

• • Quality Assurance department shall be responsible for ensuring the reconciliation of material is being followed as per the defined procedure and check the investigation details performed by the warehouse in case of the discrepancy is out of limit.

5.0   ABBREVIATIONS:

• • AR. No. : Analytical Report Number

• • API: Active Pharmaceutical Ingredients

• • HPMC: Hydroxy Propyl Methyl Cellulose

• • IPA: Iso Propyl Alcohol

• • DEFINITIONS: NA

6.0   PROCEDURE FOR RAW MATERIAL RECONCILIATION:

• • Warehouse personnel shall verify the physical stock with stock available in the system.

• • Stores/Warehouse personnel shall generate the stock statement from the system and export the data in Annexure 1 by using the Excel Sheet.

• • Warehouse personnel shall verify the materials as per the location code mentioned in the stock statement (Annexure 1).

• • Check the details like Item code, Item name, Lot No., Unit, Manufacturing, Expiry, and Retest Date from mother/ quarantine label.

• • During material physical verification, all the intact containers shall be counted and loose containers shall be weighed for weight verification.

Related: SOP for material handling and movement

• • Perform the weight verification of loose containers in the post staging area (Avoid the exposure of material).

• • Multiply all the counted containers with their net weight mentioned in the mother label of the container, for calculation of exact quantity.

• • If net weight shall not mention on the mother label, then net weight shall be calculated after subtracting the tare weight from the gross weight.

• • After completion of physical stock verification as per Annexure 1, if discrepancy found, fill the details in Annexure 2.

• • Calculate the discrepancy details by calculating the difference between System stock and physical stock as per Annexure 2.

• • Calculation of discrepancy criteria= A-B/C*100,

• • Where,

• • • A: – Quantity available in System.

• • • B: – Physical stock quantity.

• • • C: – Quantity received as per the Consignment.

• • The limit shall be considered for all raw material as follows:

• • API (Except Psychotropic/Narcotics): ± 1%.

• • Excipients: ± 3% (other than Colloidal silicon dioxide, HPMC all grade, IPA & Acetone)

• • Colloidal silicon dioxide, HPMC all grade, IPA and Acetone: ± 5%

• • Methylene Chloride: ± 10%

• • If the discrepancies are found within the limit, Warehouse Head shall execute the stock adjustment document Annexure 3.

Related: SOP for Dispensing of Raw Material

• • The discrepancies are found more than the specified limit, Operation Head shall approve the Annexure 4 for the stock adjustment in the system.

• • If the Quantity of Psychotropic/Narcotics material is less/more than the quantity in the system, then Operation Head shall approve the Annexure 5 for the stock adjustment in the system.

• • If the discrepancy exceeds the limit, investigate the discrepancy with stock movement details generated through the system.

• • Write the stock adjustment note issuance no. of Annexure 3, Annexure 4, and Annexure 5  as follows :

• • For Stock adjustment (Within Limit): WH/WL/20/001.

• • Stock adjustment (More than Limit): WH/ML/20/001.

• • Stock adjustment (Psychotropic/Narcotic): WH/PSY/20/001.

                 Where,

                 WH:-Warehouse

                 WL:-With in Limit

                 ML:-More than Limit

                 PSY:-Psychotropic/Narcotic

                 20:-Last two digits of current Year

                 001:-Serial No.

Note: Serial No. should be common for all categories (Within Limit/, More than Limit, and Psychotropic/Narcotic).

• General Practices of Raw Material Reconciliation :

• • After approval of the stock adjustment note from an authorized person, warehouse personnel shall raise the request for approval of stock adjustment issues in the system.

• • The authorized person shall approve the stock adjustment issues request.

• • After approval of the stock adjustment issues in the system, it shall be recorded in annexure 6.

• • Stock verification of excipients shall be carried out once in a year.

• • Stock verification of all the APIs shall be carried out on the rotation basis such that each material gets verified in six months.

• • During staging, if materials found short, intimate to QA. De-allocate the material pick up the list of that particular item in the system and regenerate the M.R.O. with available stock, and scheduled for physical stock verification of that item.

• • Perform batch-to-batch reconciliation of all the consumed A.R. No. of that particular material used in the batch (i.e., the reconciliation of all the A.R.No., irrespective of API or excipients, viz, color, capsules, etc. to be carried out upon completion of an A. R. Number.

• • During batch to batch reconciliation if the discrepancy is found follow the stock adjustment procedure…

7.0   ANNEXURES – SOP FOR RAW MATERIAL RECONCILIATION:

Annexure 1: Stock Statement.

Prepare the Stock Statement Register/log with the following table content-

• • Date

• • Item Code

• • Item Name

• • LOC Code

• • Lot No.

• • Unit

• • Quantity

• • Allocated

• • System Stock

• • Manufacturing Date

• • Expiry Date

• • Retest Date

• • Physically Stock Available

• • % Difference

• • Stock Adjustment Required (Y/N)

Annexure 2: Stock Verification Record.

Prepare the Stock Verification/log with the following table content-

• • Date

• • Sr.No.

• • Item Name
  • Item Code

• • A.R. No/Lot No

• • Received Qty. (Kg.)

• • Stock as per Metis (Kg.)

• • Physical Stock (Kg.)

• • Discrepancy Observed (Kg.)

• • Discrepancy Observed (%)

• • Remarks

Annexure 3: Stock Adjustment Note (Within limit).

Date____________

Annexure 4: Stock Adjustment Note (More than limit).

Date____________

Annexure 5: Psychotropic/Narcotics Materials Stock Adjustment Note.

Annexure 6: Stock Adjustment Log Book.

Prepare the Stock Adjustment Register/log with the following table content-

• • Sr. No.

• • Item Name

• • Item Code

• • A. R. No.

• • Adjusted Quantity

• • Adjustment Note Issuance No.

• • Stock Adjustment Note issuance Date

• • Adjustment Issue Doc. No. (System Generated)

• • Adjustment Issue Doc. Date

• • Remarks