SOP on Receipt of Raw Materials and Packaging Materials

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1.0 Objective:

To lay down a procedure for receiving the raw materials and packaging materials.

2.0 Scope:

This SOP is applicable for receipt of Raw and Packing material to warehouse of pharmaceutical formulation plant.

3.0 Responsibility:

Officer or above-warehouse is responsible for receipt of raw materials and packing materials

4.0 Accountability:

Head- warehouse shall be responsible for compliance and implementation of SOP.

5.0 Abbreviations and Definitions

  • RM             :           Raw Material
  • PM             :           Packaging Material
  • GRN           :          Goods Receipt Note
  • MRIN          :           Material Received and Inspection Note
  • COA            :          Certificate of Analysis
  • AVL             :           Approved Vendor List

6.0 Procedure:

6.1 Receipt of the Material

6.1.1 Upon arrival of the vehicle with material, the security personnel checks the delivery documents and ensures that consignment is meant for pharmaceutical formulation plant.

6.1.2 After confirmation of the address, the documents related to the consignment shall be sent to warehouse office for verification before making entries into “Security Register for Incoming RM/PM” Annexure-I.

6.1.3 Warehouse Personnel shall collect the documents through window and check the following in the delivery documents (delivery Challan / invoice).

  • Appropriateness of company address on the delivery documents.
  • The vendor is approved as per current version of Approved Manufacturer / Supplier List, including address.
  • Availability of Vendor Certificate of Analysis copy.
  • Reference of Purchase Order number on the delivery documents.
  • Description of the material (Material name, grade/ pharmacopeia status, quantity) in purchase order tallies with that mentioned in delivery document.

6.1.4 In case of any discrepancies observed in the above mentioned points, shall be informed to HOD – Warehouse, and HOD – Purchase for corrective action, and vehicle should not be allowed to enter if applicable.

6.1.5 After ensuring the adequacy of the received documents; the warehouse personnel shall send back the documents to security personnel to make entries in the “Security Register for Incoming RM/PM”.

6.1.6 Security personnel shall make entries in the “Security Register for Incoming RM/PM” as per Annexure-I, after receiving the consignment documents from warehouse.

6.1.7 After entering the required details, the security personnel shall stamp on the back side of the Invoice / Delivery Challan with serial number as per “Security Register for Incoming RM/PM”, and received date with signature.

  • The following stamp format shall be used.

                   PHARMAPATHWAY

GATE ENTRY No. _____ BILL No. _____

VEHICLE No. _________ DATE _________

SIGN. OF SECURITY OFFICER

6.1.8 “Gate Entry No” mentioned in the above stamp format, shall be in the form of serial number i.e. 1, 2, 3, and so on.

6.1.9 Allow the vehicle to enter in to the plant premises.

6.2 Pre-unloading activities

6.2.1 Upon arrival of the vehicle of material at unloading area, carry out the following activities.

  • Ensure that the vehicle is covered properly to protect the material.
  • Instruct the vehicle driver to stop the engine to avoid carbon spillage from silencer, till completion of unloading and transfer of material into Material Receiving Area.
  • Ensure cleanliness of vehicle.
  • Warehouse personnel shall check the consignment to ensure absence of material other than mentioned in the delivery documents, in order to avoid mix-ups.
  • Ensure that the Vehicle is not carrying any pesticides or oily material and shall be free from abnormal odor.
  • Ensure the material receiving area is clean before unloading the material.
  • Ensure the cleanliness of the dedicated pallets available at the receiving platform.
  • Ensure the cleanliness and working condition of the Hydraulic pallet trolley and vacuum cleaner.
  • Ensure the air curtain is in working condition.
  • Before starting the De-dusting operation ensure that the inside door is closed.
  • Ensure the weighing balance is calibrated.
  • Record the observations in the format as mentioned in Annexure-II

Note: Ensure that at a time only one consignment is unloaded.

6.3 Unloading activities

6.3.1 The material shall be unloaded from the vehicle under supervision of warehouse personnel.

6.3.2 Ensure to unload the material safely from the vehicle onto the cleaned dedicated pallets on the receiving platform.

6.3.3 Open the door of Material Receiving Area to receive the material. Ensure that the other door of the room is closed.

6.3.4 Transfer the loaded pallets with material into Material Receiving Area and keep them within the demarked blue line meant for cleaning/ de-dusting of received materials.

6.3.5 The Warehouse personnel shall verify each Container, Bag, Box or Drum Identification integrity in terms of physical appearance of the consignment against the “Consignment Check List for Raw Material & Packaging Material” Annexure-II. The following details shall be verified.

  • Material Name (To match with COA and Label on the received pack)
  • Supplier/ Manufacturer Address. (To match with Approved Vendor list)
  • Batch Number (where ever applicable).
  • Manufacturing date (if available on the container/ Certificate of Analysis copy.)
  • Expiry date / Retest date. (As available on the container/ Certificate of Analysis copy).
  • Check any storage conditions are mentioned on the container label.

Note: COAs, Manufacturing date, Expiry date, and Storage conditions may not be required for secondary/ Tertiary Printed and unprinted packaging material.

6.3.6 Deface the supplier’s / Manufacturer’s approved label available on the container / pack by making “X” mark by marker pen.

6.3.7 Physically verify all the unloaded containers / packs, for identification, integrity, intactness of seal, and Quantity as per Delivery documents.

6.3.8 If it is tallied, acknowledgement for material receipt is given to the driver of the vehicle by stamping sign on the copy of the delivery documents.

  • The following stamp format shall be used.
PHARMAPATHWAY

STORES RECEIVED

P.O No. ……………………………………………

No. of packs…………… Gate Entry No………….

Total Qty……………………………………………..

REMARK…………………………………………….

………………………………………………………..

SIGN………………….  Date……………………….

SUBJECT TO PHYSICAL VERIFICATION

6.3.9 If anything found damaged or unusual, handle them as explained in section 6.9.

  • In case of any shortage, damaged, broken or tampered materials (occurred due to the fault of transporter) is received, the same nature of remarks shall be mentioned on all copies of delivery documents and sign of the driver should be taken as a confirmation.
  • Communication is given to Quality Assurance department by raising the “Material Discrepancy Report as per Annexure-IV, to review the impact, and to initiate further action.

6.4 DE-DUSTING PROCEDURE

6.4.1 De-dusting of the containers / packs for API and Excipients.

  • Clean the external surface of the container one by one by using the vacuum cleaner (refer RESPECTIVE SOP).
  • Rotate the container sideways and ensure the vacuum suction cleans all external surfaces, top and bottom of containers during the de-dusting.
  • Clean the container with lint free duster.
  • Ensure to handle the containers carefully to avoid falling and loosing of the seal during de-dusting.
  • After de-dusting and cleaning, ensure to segregate the material as per batch / lot wise.
  • Transfer the cleaned containers on to the clean pallet kept on the other side of the Demarked blue line.

6.4.2 De-dusting of containers / packs for Excipients and Primary Packaging Material in bags/ shippers.

  • Clean the external surface of the packs one by one by using the vacuum cleaner.
  • Lift the Pack and ensure the vacuum suction cleans entire external surface of the pack during the de-dusting.
  • Ensure to handle the packs carefully to avoid falling and damage to the external surface of the pack (Integrity) during de-dusting.
  • After cleaning and de-dusting, ensure to segregate the material as per batch / lot wise.
  • Transfer the cleaned packs on to the clean pallet kept on the other side of the Demarked blue line.

Note: After de-dusting the shippers of Lidding foils and forming films shall be opened and the rolls of the foils and films with protective polythene cover shall be transferred into another polythene cover and tied with cable tie before affixing quarantine label and transfer into Quarantine area.

6.4.3 De-dusting of Secondary (Printed) Packaging Material shippers

  • Clean the external surface of the packs one by one by using the vacuum cleaner.
  • Lift the Pack and ensure the vacuum suction cleans entire external surface of the pack during the de-dusting.
  • Transfer the cleaned packs on to the clean pallet kept on the other side of the Demarked blue line.
  • Ensure that only one consignment is received and handled at a time to avoid mix-ups.

6.4.4 De-dusting of Un-printed Packaging Material in Bundles.

  • Clean the external surface of the packs one by one by using the vacuum cleaner.
  • Lift the Pack and ensure the vacuum suction cleans entire external surface of the pack during the de-dusting.
  • Transfer the cleaned packs on to the clean pallet kept on the other side of the Demarked blue line.

6.5 Post de-dusting procedure

6.5.1 Ensure that out side door of Material Receiving Area is closed.

6.5.2 After Completion of de-dusting operation ensure vacuum cleaner is kept in its cover before cleaning.

6.5.3 Ensure the Waste generated in the de-dusting area is disposed off in waste bin provided.

6.5.4 Open the inside door of Material Receiving Area and transfer the containers / packs lot / batch wise for weighing.

6.5.5 Ensure the inside door of Material Receiving Area is closed.

NOTE: During de-dusting and cleaning operation keep both the doors of the Material Receiving Area in closed condition.

6.6 Weighing or Quantity verification procedure

6.6.1 Transfer the containers / packs by using hydraulic pallet trolley with lot wise to the weighing area.

6.6.2 Check for the cleanliness of the balance and ensure its routine calibration as per respective SOP No.

6.6.3 Switch on the balance and wait till zero display comes.

6.6.4 Weigh the containers/packs received one by one, on the balance provided and ensure that quantity received is tallying as mentioned in delivery documents.

6.6.5 Follow the below mentioned weighing table plan for verification of the received containers.

S. No. Type of materials No. of container received in batch No. of container to be verified Remark
01 Active Pharmaceutical Ingredients 100 %
02 Excipients 5 1
03 Excipients 5 to 10 2 *And so on
04 Forming Films and Lidding Foils 100%
Note: *After 10 containers, for each additional five (less than 5 also) containers received verify one container extra.

6.6.6 Record the gross weight in “Quantity Verification Record” as per Annexure-III.

6.6.7 In case of any discrepancy in the material, prepare “Material Discrepancy report” Annexure-IV and inform to vendor through purchase department.

6.6.8 After completion of weighing, “switch off” the balance and ensure for its cleanliness. (Refer respective SOP).

6.6.9 After weighing the packs, shall be kept on pallets for storage as per SOP on “Labeling and Storage of Raw and Packaging Material” (refer respective SOP.)

Note: All the API containers, Excipients containers/ packs, forming film/ lidding foil rolls shall be verified for their gross weights. Other Primary packaging material and secondary Packaging Material shall be verified for their quantity in numbers against the received documents.

6.7 Quarantine Procedure

6.7.1 Affix “Quarantine Label” Annexure-I, on the packs and shift them to their respective quarantines as per SOP on “Labeling and Storage of Raw and Packaging Material”.

6.7.2 Transfer the material to respective Quarantine area and store the material as per recommended storage conditions.

6.7.3 Ensure the cleanliness of the storage racks.

6.7.4 Stack the materials in designated storage racks.

6.7.5 The warehouse personnel shall enter the material details in “Incoming Material Register (Raw material)” as per Annexure-V and “Incoming Material Register (Packaging material)” as per Annexure-VI.

6.6.6 Warehouse-Personnel shall prepare the GRN (Goods Received Note) as per Annexure-VII.

6.6.7 GRN Numbers shall be given as explained below.

RM-1

6.7.8 The received material quantities shall be updated in the “Material Stock Card” Annexure-VIII. (Receipt and Issue shall be printed front and back of card respectively).

6.7.9 The Goods Received Note (GRN) for Raw Material and Packaging Material shall be in duplicate copies.

  • The white copy – for store record,
  • The red copy – for QC record,

6.7.10 Send Goods Received Note (GRN) to Quality Control Department.

6.7.11 Quality Control Department shall initiate for material sampling.

6.7.12 Co-ordinate with Quality Control chemist for batch wise sampling.

6.7.13 Quality Control personnel shall do the sampling from the received material, and affix “Sampled” labels duly filled & signed on the containers/ packs which have sampled for testing.

6.7.14 Ensure the sampled containers/packs are re-sealed properly and repacked back as per respective SOP., and send to its respective location.

6.7.15 Quantity of sample withdrawn by Quality control personnel shall be recorded in GRN and warehouse personnel shall transcribe the quantity into “Material Stock Card”, Annexure-VIII after final approval of GRN from QC Head.

6.8 Approval/ Rejection

6.8.1 After analysis, Quality Control shall send back the Goods Receipt Report (GRN) to warehouse indicating the material status (Approved or Rejected) along with the Certificate of Analysis.

6.8.2 After Testing and Release of the materials by QC, each container with “Quarantine” label shall be affixed with “Approved” label duly filled & Signed by Quality Control Personnel.

6.8.3 Warehouse personnel shall transfer the Approved material from “Quarantine area” to the respective Approved material Storage areas. Transfer shall follow “Labeling and Storage of Raw and Packaging Material”.

6.8.4 Rejected material (If any, by QC) it shall be labeled as “REJECTED” duly filled & signed (Annexure-IV) and shall be transferred to Rejected material room.

6.8.5 The details of the rejected material shall be informed to the Purchase department for further action.

6.8.6 Warehouse personal shall raise MRIN (Material Receipt and Inspection Note), Annexure-IX for sending to the accounts department indicating the material receipt and acceptance status for further commercial proceedings.

6.9 Handling of shortages/ Improper labeling (Identification)/ damaged consignment:

6.9.1 Shortages:

  • If number of packs received is less than that indicated in the documents and Purchase Order note the details of shortage on the Transporter Bill.
  • Take signature from the driver.
  • Inform HOD-Warehouse and HOD-Purchase by telephone/ e-mail.
  • Upon approval by HOD Purchase and/ or Plant Head the material may be accepted with a shortage note in the “Material Discrepancy report Annexure-IV.
  • Further action on commercial aspects with the Vendor shall be taken up by Purchase Department.

6.9.2 Improper labeling/ Identification:

  • Any discrepancy in terms of improper labeling/ Identification of the containers/packs against the PO and documents shall be immediately inform to HOD – Warehouse, Head-Purchase.
  • If the discrepancy is confirmed that material received shall be kept in the Rejected material room.
  • The material shall be rejected with a note in the “Material Discrepancy report”, Annexure-IV.
  • Further action on commercial aspects with the Vendor shall be taken up by Purchase Department.

6.9.3 Damaged Goods:

  • If the received material is physically in damaged condition:
  • Note the details in the “Material Discrepancy report”, Annexure-IV.
  • Inform to HOD–Warehouse-Purchase and Plant Head.
  • If Raw material and API containers/ packs received in damaged condition:
    • Minor damages like dents are acceptable for Raw material and Non-sterile API containers/ packs.
    • Minor damages are not acceptable for sterile API and the material should be rejected.
    • Transfer them to rejected material room after affixing the “INPROCESS -REJECTED” label. As per respective Annexure.
  • If printed packaging material is received in damaged condition and are not in usable condition.
    • Transfer them to rejected material room after affixing the “INPROCESS -REJECTED” label.
    • Inform the purchase department.
    • Printed packaging material should not be returned to the vendor.
    • These materials must be destroyed inside the plant after getting approval from HOD-QA and Plant Head in presence of QA and Vendor representative/ vendor concurrence.
  • If un-printed packaging material received in damaged condition.
    • Transfer them to rejected material room after affixing the “REJECTED” label.
    • These can be sent back to the vendor.
  • If primary packaging material is received in damaged condition.
    • Damaged packs shall be segregated from the good packs.
    • Good packs may be acceptable after QC and QA verification.
      • In case of damage in the consignment of Raw Material and Packaging Material except printed packaging material, as explained above, shall be sent back to the manufacturer/ supplier, along with ‘Gate Pass Returnable / Non-Returnable’ as per Annexure-X detailing the reason for return appropriate transport system.

6.10 Handling of Material for Pilot-Bio batches, Process Optimization, Scale up and Pre-exhibit trials:

6.10.1 In case of consignments received for Pilot-Bio batches, Process Optimization, Scale up and Pre-exhibit trials shall follow same material receipt procedure mentioned in this SOP.

6.10.2 Vendor details, Vendor COA, and relevant documents for these materials shall be provided by Formulation Research and Development Lab.

6.10.3 Raise GRN and obtain Quality Control consent for issuing of materials for Pilot-Bio batches, Process Optimization, Scale-up and Pre-exhibit trials.

6.10.4 QC shall provide permission in the “Consent for use of material in Pilot-Bio batches, Process Optimization, Scale up and Pre-exhibit trials”, Annexure-XI.

6.10.5 However in such cases, the consignment status may be decided by routine sampling and testing by Quality control or the material may be released by Quality Control Department based on the COA provided by Formulation Research and Development Department.

7.0 Forms and Records (Annexures)

7.1 Security register for incoming (Raw Material and Packaging Material)                –  Annexure-I

7.2 Consignment Check list (Raw Material & Packaging Material)                         –  Annexure-II

7.3 Quantity Verification Record                                                                         –  Annexure-IIII

7.4 Material Discrepancy Report                                                                         –  Annexure-IV

7.5 Incoming material register (Raw Material)                                                       –  Annexure-V

7.6 Incoming material register (Packaging Material)                                            –  Annexure-VI

7.7 Goods Received Note                                                                                 –  Annexure-VII

7.8 Material Stock Card                                                                                   –  Annexure-VIII

7.9 Raw/Packing Material receipt and inspection note                                          –  Annexure-IX

7.10 Gate pass returnable / non-returnable                                                           –  Annexure-X

7.11 Consent for use of material in Pilot-Bio batches, Process Optimization,

Scale up and Pre-exhibit trials                                                                              –  Annexure-XI

8.0 Distribution

8.1 Master copy             –           Quality Assurance

8.2 Controlled copies –          Warehouse, Personnel and Administration, Quality Assurance and Quality Control

9.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

Annexure-I

s3-1

Annexure-II

Consignment Check List (Raw Material & Packaging Material)

Material Name: ______________________                          Date: ______________

DC / Invoice No & Date.:________________

Activity Observation Remarks
Document Verification

1.   Address of “Nectar Lifesciences Ltd.-Unit VI” on vendor  documents

2.   Delivery Challan / Invoice copy

3.   Purchase Order Number in Vendor documents

4.   Supplier & manufacturer Name/ address as per  “ Approved Vendor List”

5.   COA from supplier / manufacturer.

6.   CENVAT Copy of Invoice & Form-26

7.   Security stamp on document.

 

Correct / Incorrect

 

Available / Not available

Available / Not available

 

Correct / Incorrect

 

Available / Not available

Available / Not available

Available / Not available

Done By:- Checked By:-
Pre-Unloading Operation at Receiving Bay

1.   Vehicle is properly covered.

2.   Cleanliness of vehicle

3.   Vehicle is not carrying any pesticides or oily materials

4.   The vehicle shall be free from abnormal odor

5.   Ensure the vehicle engine shall be “stopped” till completion of unloading activity.

6.   Ensure cleanliness of handling equipment and Vacuum cleaner

7.   Air curtain is switched on.

 

 

Yes / No

Yes / No

Complies / Not complies

 

Yes / No

 

Complies / Not complies

 

 

Cleaned / Not cleaned

 

Yes / No

 

Done By:- Checked By:-
Unloading Operation

1.   Unloading done on cleaned dedicated pallets

2.   Physical condition  of the material

3.   Identification labels on the container/packs as per DC/Invoice

4.   No of Packs as per DC/Invoice

5.   Any Discrepancy.

 

Yes / No

 

Checked / Not Checked

Satisfactory /  Not

Satisfactory

Yes / No

Yes / No (If yes, prepare

Material Discrepancy Report)

Done By:- Checked By:-

 

De-dusting Operation

1.   Ensure both the doors are closed

2.   De-dust the containers / packs with Vacuum cleaner.

3.   Transfer the containers / packs  in to cleaned pallets.

 

 

Yes / No

Yes / No

 

Yes / No

Done By:- Checked By:-
Post De-dusting Operation

1.     Vacuum Cleaner kept back in its pack.

2.     Waste generated during de-dusting operation is disposed off in waste bin.

 

Yes / No

Yes / No

Done By:- Checked By:-
Weighing Operation

1.    Weighing balance is calibrated

2.    Daily Verification of balance.

3.    Any Discrepancy in weight

 

4.    Acknowledgement given to Driver duly stamped

 

 

Calibrated / Not Calibrated

Verified / Not verified

Yes / No (If yes prepare Discrepancy Report)

Stamped / Not Stamped

 

 

Done By:- Checked By:-
Quarantine Operation

1.     Affix Quarantine labels on containers/ packs.

2.     Transfer the material to respective Quarantine Area’s

3.     Entry Taken/done in incoming register.

4.     GRN is prepared.

5.     Material stock card updated.

 

Yes / No

 

Transferred/ Not Transferred

 

Yes / No

Yes / No

Yes / No

Done By:- Checked By:-

 

Sign/Date: ___________________

(HOD –Warehouse)


Annexure-III

                Quantity Verification Record

Material Name:                                                                       GRN No   :

Supplier Name:                                                                     GRN Date:

Manufacturer Name:

Invoice No. / D.C. No. & Date:

S.No. Batch No. Gross Weight

as per D.C/ Invoice

Gross Weight Physical Observed Remarks
 

Weighed By:                                                   Checked By:

Annexure-IV

MATERIAL DISCREPANCY REPORT

Nature of Discrepancy:

Material name:

Supplier Name       :

Manufacturer Name:

D.C. No. / Invoice No. & Date:

Transporter’s Name:                                                                              L.R.No:

Qty as per D.C/Invoice :

Excess / Shortage Qty:                                  Actual Received Qty:

Damage in:                 Outer pack                              Inner pack

Details:

S. No Batch No. Pack No Mfg. Date Exp. Date QTY. Remarks
 

QA Inspection status:              Damage-Accepted                 Not accepted

Return to vendor                    Repack

Recommended stocks to be taken: ______________________

Vehicle Driver:                 Name: __________   Sign/Date   ____________

QA Inspected by:              Name: ________     Sign/Date   ______________

Reported by Warehouse:        Name: _______Sign/Date   : _____________

Remarks:…………………………………………………………… …………

(HOD-WH) Sign./Date

SA-1

Annexure-VII

GOODS RECEIVED NOTE
G.R.N. No.__________________ G.R.N. Date______________ Item code______________
Material______________________________________________ Qty. Received__________
Supplier’s Name________________________________________________ No. of containers________
Manufacturer’s Name________________________________________________ Invoice No._____________
Batch No.__________________ Packaging status__________ Invoice Date____________
Mfg. Date_________________ Exp. / Best before / Revaluation date____________
 

 

Analysis required as per – IP / USP / BP / EP / IH                                              Signature (Stores)

(Pls. mark √ as required)

SAMPLER’S COMMENTS
No. of cont. sampled_____________________ Sampled Qty.________________________
Sampled by____________________________ Sampled on__________________________
Sampler’s remarks_____________________________________________________________

Sampled by (Q.C.)

QC COMMENTS
A.R. No._________________ Release Date_____________ Potency / Assay_________
L.O.D / Moisture________________________ Approved / Rejected___________________
Analyst Remarks_______________________________________________________________
Retesting due on________________________
 

Analysed by                                                                                                                Approved by

SA.2'docx-1

Annexure-IX

Raw / packing Material receipt & inspection note

Supplier:- P.O.No:- Bill No:- GR No:-
Date:- Date:- Date:-
Transporter: M/s                                                                                                     Vehicle No.
S.No Description Quantity Received Quantity.

as per Challan/

Bill

Rate Amount Q.A.

Remarks

Accepted Rejected Total

received

 

 

 

Prepared by                          Inspected & Approved by                                         Authorized by

Remarks:  Red  Colour for Raw Material & Yellow Colour for PM have been followed separately.

 

Annexure-X

Works:  Address

(Gate Pass Returnable/Non Returnable)

Our C.S.T. No.: Sr. No.
Our LST: Date

 

_____________________________________________________________________________

Consignee: ___________________________________________________________________

_____________________________________________________________________________

Party’s C.S.T. No.________________________________________________________

Through: ___________________________________________________________________

S. No. Material Description Unit Quantity Approx. Value Remarks
 

Purpose: __________________________________________________________________

Tentative date of return: _____________

 

Prepared by         Checked by                     Authorized by                      Received by

Annexure-XI

Consent for use of material in Pilot-Bio batches, Process Optimization, Scale up and Pre-exhibit trials

 

Material                : __________________________________________________

GRN No.             : _____________               Quantity             : _______________

 

GRN Receipt Date        : _____________

 

Consent By           :      __________________

(Head / Deputy – QC)

 

Sign

Date
 

Authorized  By     :      __________________                                       (Head / Deputy – QA)

 

 

Sign

Date

 

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