1.0 Purpose
To lay down a standard procedure for receiving Raw and Packaging materials in the
Warehouse.
2.0 Scope
This SOP shall be applicable for receipt of Raw and Packaging materials to Warehouse of
"NAME" Pharma Limited at "Location".
3.0 Responsibility
3.1 Officer, Warehouse or above is responsible for receipt of Raw and Packaging materials.
3.2 Head of, Warehouse is responsible for compliance and implementation of this SOP.
4.0 Abbreviations and Definitions
4.1 RM : Raw Material
4.2 PM : Packaging Material
4.3 COA : Certificate of Analysis
4.4 GRN : Goods Receipt Note
5.0 Materials & Equipment
5.1 Not Appreciable
6.0 Precaution
6.1 All materials shall be handled carefully to avoid contact with any contaminants.
6.2 All personnel shall use proper means and methods to prevent damage or deterioration or contamination.
6.3 Mishandled or damaged materials or products shall be immediately reported to responsible authority.
6.4 Container that dirty must be cleaned. Unnecessary outer packing materials must be cleaned.
7.0 Procedure
7.1 Receipt of the Material
7.1.1 Upon arrival of the vehicle with material, the security personnel checks the delivery documents and ensures that consignment is meant for pharmaceutical formulation plant.
7.1.2 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”.
7.1.3
Warehouse Personnel shall collect the documents 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.
7.1.4
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.
7.1.5
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”.
7.1.6
Security personnel shall make entries in the
“Security Register for Incoming RM/PM” after receiving the consignment
documents from warehouse.
7.1.7
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.
7.1.8
“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.
7.1.9
Allow the vehicle to enter in to the plant
premises.
7.2 Pre-Unloading
Activities
7.2.1
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 materials.
·
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.
Note: Ensure
that at a time only one consignment is unloaded.
7.3 Unloading Activities
7.3.1
The material shall be unloaded from the
vehicle under supervision of warehouse personnel.
7.3.2
Ensure to unload the material safely
from the vehicle onto the cleaned dedicated pallets on the receiving platform.
7.3.3
Open the door of Material Receiving
Area to receive the material. Ensure that the other door of the room is closed.
7.3.4
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.
7.3.5 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”. 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.
7.3.6
Deface the supplier’s / Manufacturer’s
approved label available on the container /
pack by making “X” mark by marker
pen.
7.3.7
Physically verify all the unloaded
containers / packs, for identification, integrity,
intactness of seal, and
Quantity as per Delivery documents.
7.3.8
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.
7.3.9
If anything found damaged or unusual,
handle them as explained in section 7.9.
·
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” to
review the impact, and to initiate further action.
7.4 De-Dusting Procedure
7.4.1 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.
· 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.
7.4.2
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.
7.4.3
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.
7.4.4 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.
7.5 Post De-Dusting Procedure
7.5.1 Ensure
that outside door of Material Receiving Area is closed.
7.5.2 After
Completion of de-dusting operation ensure vacuum cleaner is kept in its cover
before cleaning.
7.5.3 Ensure
the Waste generated in the de-dusting area is disposed off in waste bin
provided.
7.5.4 Open
the inside door of Material Receiving Area and transfer the containers / packs
lot
/ batch wise for weighing.
7.5.5 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.
7.6 Weighing Or Quantity Verification Procedure
7.6.1 Transfer
the containers / packs by using hydraulic pallet trolley with lot wise to the
weighing area.
7.6.2 Check
for the cleanliness of the balance and ensure its routine calibration as per
respective SOP.
7.6.3 Switch
on the balance and wait till zero display comes.
7.6.4 Weigh
the containers/packs received one by one, on the balance provided and ensure
that quantity received is tallying as mentioned in delivery documents.
7.6.5 Follow
the below mentioned weighing table plan for verification of the received
containers
|
Sl. No. |
Type of
Materials |
No.
of Container received in batch |
No.
of Container to be verified |
Remarks |
|
01 |
Active Pharmaceutical Ingredients |
-- |
100 % |
-- |
|
02 |
Excipients |
5 |
1 |
-- |
|
03 |
Excipients |
5 to 10 |
2 |
* And so on |
|
04 |
Forming films & Lidding Foils |
-- |
100 % |
-- |
7.6.6 Record
the gross weight in “Quantity Verification Record”.
7.6.7 In
case of any discrepancy in the material, prepare “Material Discrepancy report”
and inform to vendor through purchase department.
7.6.8 After
completion of weighing, “switch off” the balance and ensure for its
cleanliness. (Refer respective SOP).
7.6.9 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.
7.7 Quarantine Procedure
7.7.1 Affix
“Quarantine Label” on the packs.
7.7.2 Transfer
the material to respective Quarantine area and store the material as per
recommended storage conditions.
7.7.3 Ensure
the cleanliness of the storage racks.
7.7.4 Stack
the materials in designated storage racks.
7.7.5 The
warehouse personnel shall enter the material details in “Incoming Material
Register (Raw material)” and “Incoming Material Register (Packaging material)”.
7.7.6 Warehouse-Personnel
shall prepare the GRN (Goods Received Note).
7.7.7 GRN
Numbers shall be given as explained below.
7.7.8 The
received material quantities shall be updated in the “Material Stock Card”
(Receipt and Issue shall be printed front and back of card respectively).
7.7.9 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,
7.7.10
Send Goods Received Note (GRN) to
Quality Control Department.
7.7.11
Quality Control Department shall
initiate for material sampling.
7.7.12
Co-ordinate with Quality Control
chemist for batch wise sampling.
7.7.13
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.
7.7.14
Ensure the sampled containers/packs are
re-sealed properly and repacked back and send to its respective location.
7.7.15
Quantity of sample withdrawn by Quality
control personnel shall be recorded in GRN and warehouse personnel shall
transcribe the quantity into “Material Stock Card” after final approval of GRN
from QC Head.
7.8 Approval/ Rejection
7.8.1
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.
7.8.2
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.
7.8.3
Warehouse personnel shall transfer the
Approved material from “Quarantine area” to the respective Approved material
Storage areas.
7.8.4
Rejected material (If any, by QC) it
shall be labeled as “REJECTED” duly filled & signed and shall be
transferred to Rejected material room.
7.8.5
The details of the rejected material
shall be informed to the Purchase department for further action.
7.8.6
Warehouse personal shall raise MRIN
(Material Receipt and Inspection Note) for sending to the accounts department
indicating the material receipt and acceptance status for further commercial
proceedings.
7.9 Handling Of Shortages/ Improper Labeling
(Identification) / Damaged Consignment:
7.9.1
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”.
· Further action on commercial aspects with the Vendor shall be
taken up by Purchase Department.
7.9.2
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”,
· Further action on commercial aspects with the Vendor shall be
taken up by Purchase Department.
7.9.3
Damaged Goods:
·
If the received
material is physically in damaged condition:
·
Note the details in
the “Material Discrepancy report”.
·
Inform to
HOD–Warehouse-Purchase and Plant Head.
·
If Raw material and API
containers/ packs received in damaged condition:
o Minor damages like dents are acceptable for Raw material and
Non-sterile API containers/ packs.
o Minor damages are not acceptable for sterile API and the material
should be rejected.
o Transfer them to rejected material room after affixing the
“INPROCESS -REJECTED” label.
·
If printed packaging
material is received in damaged condition and are not in usable condition.
o Transfer them to rejected material room after affixing the
“INPROCESS -REJECTED” label.
o Inform the purchase department.
o Printed packaging material should not be returned to the vendor.
o 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.
o Transfer them to rejected material room after affixing the
“REJECTED” label.
o These can be sent back to the vendor.
·
If primary packaging
material is received in damaged condition.
o Damaged packs shall be segregated from the good packs.
o 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 detailing the reason
for return appropriate transport system.
7.10 Handling Of Material For Pilot-Bio Batches, Process
Optimization, Scale Up And Pre-Exhibit Trials:
7.10.1 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.
7.10.2 Vendor
details, Vendor COA, and relevant documents for these materials shall be provided
by Formulation Research and Development Lab.
7.10.3 Raise
GRN and obtain Quality Control consent for issuing of materials for Pilot-Bio
batches, Process Optimization, Scale-up and Pre-exhibit trials.
7.10.4 QC
shall provide permission in the “Consent for use of material in Pilot-Bio
batches, Process Optimization, Scale up and Pre-exhibit trials”.
7.10.5 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 Product Development Department.
8.0 Reference Document
8.1
WHO Good
Manufacturing Practices Guideline
8.2 In-house
9.0 Annexure
9.1 Annexure-I : Goods Received Note (GRN)
9.2 Annexure-II : Raw Materials Receiving Register
9.3 Annexure-III : Packing Materials Receiving Register
9.4 Annexure-IV : Raw Materials Stock Register
9.5 Annexure-V : Packaging Materials Stock Register
9.6 Annexure-VI : Rejection Register (RM/PM)
10.0 Revision History
|
Version No. |
Brief
Reason for the Revision |
Effective Date |
Remarks |
|
01. |
|
|
- |
|
02 |
|
|
|
|
03. |
|
|
|
11.0 Training
11.1 Training on this SOP is required for respective operators and Executives of Warehouse
