SOP Number:WH-003

Title: Standard Operating Procedure for Material Receiving, Segregation, Storage and
Distribution

1.Purpose
The purpose of this SOP is to ensure that goods are received, checked, stored, delivered and returned in a
consistent manner.
2.Scope
This procedure applies to all incoming materials that are stored in company’s ware house.

3.Validity
This SOP is valid up to the next revision date and only if it bears the control seal.

4.Responsibility
The store keeper, the head of property division are responsible for the implementation of this SOP
5.Materials and Equipment
None
6. Procedure
6.1 RECEIVING GOODS
6.1.1. Components (raw materials), drug product containers and closures, packaging and labeling
materials shall be physically inspected on receipt for correct labeling, correctness of supplier, correctness
of container/packaging material, as stated in the material specification, integrity (damage) of the
container or closure system, physical contamination with dirt of the container closure system and for
agreement between quantity ordered and quantity supplied.
6.1.2. All components, drug product containers and closures, packaging and labeling materials whose
container closure systems are grossly damaged or contaminated with foreign matter shall be segregated
and separately quarantined pending decision on their future.

SOP Number:WH-003
6.2 SEGREGATION:

6.2.1. All components, drug product containers and closures, packaging and labeling materials that
have not been approved by the QC shall be quarantined and stored separately in a quarantine area and
withheld from use until such approval is secured from the QC.

6.2.2. All components, drug product containers and closures, packaging and labeling materials that
 have been approved by the QC shall be labeled with proper QC approval label and stored in a
separate area designated for approved materials.

6.2.3. All components, drug product containers and closures, packaging and labeling materials that
have been rejected by the QC shall be labeled with proper QC rejection label and shall be removed
immediately and quarantined in a reject area designated for such materials pending destruction.

6.3. STORAGE

6.3.1. All components, drug product containers and closures, packaging and labeling materials shall
be stored in a clean store, off the ground, in a manner that would permit easy cleaning and
identification.
6.3.2. The temperature and humidity of the storage facility shall be monitored and recorded on a daily
basis.
6.3.3. Labels and labeling materials for different products or different strengths of the same product
are to be kept separate – often by the use of drawers, cubicles or cupboards, so as to minimize the
Potential for mix-ups, free from dirt and dust and at controlled humidity condition.

6.4. DELIVERY OF GOODS

6.4.1. Issue and distribution of all components, drug product containers and closures, packaging and
labeling materials and drug products shall be in writing and the records are to be signed,
approved and maintained.
6.4.2. Appropriate stock rotation procedure shall be implemented to allow the use of first approved
material to be used first. This requirement may be modified if there is any justification and
shall be approved.

5.0 PROCEDURE
5.1 The receipt of each Raw and Packing Material is intimated by security.
5.2 After receipt of the intimation of the consignment each document should be examined carefully for •
Whether the material belongs to group companies
• Delivery Challan
• Whether the material is received as per Purchase Order
• Whether the material received from Approved Vendors
• Cenvat Copy / Bill of Entry
• Mfg. COA
5.3 Before unloading inspect the vehicle for cleanliness.
5.4 Each delivery of Raw and Packing Material should be examined visually while unloading, such as:
• Proper labeling of each container, and also check the intactness of the container.
• Match information on outer shippers or packs as mentioned in Delivery Challan.
• If Material received in Damage / Breakage / Leakage or not in intact conditions, such container is to be
segregated from other material and kept aside in a suitable manner.
• Record the discrepancy in material discrepancy note and intimate to HOD QA & QC and take
necessary action as instructed by HOD QA & QC.
5.5 Each container, bags and packet should be cleaned from outside by vacuum cleaner/dry lint-free
cloth in receiving bay.
5.6 At the time of unloading Raw/Packing material it should be crossed verified with Invoice / Delivery
challan and must checked physically for the following points for its correctness:
• Name of Material.
• Quantity per packet/Container
• Mfg. Date/Expiry Date, /Use before date
• Batch No.
• Net. Weight, Gross Weight, Tare Weight.
• Storage condition on pack (container/Poly bag/box etc).
5.7 After de-dusting store person shall shift the material in the staging area for physical verification.
5.8 Physical verification for actual quantity is carried out for all RM & PM.
5.9 For packaging materials, random verification will be performed for checking the correctness of
quantity mention on the label by the party which will be mention in physical .0 PROCEDURE 5.1 The
receipt of each Raw and Packing Material is intimated by security.
5.10 Check the Item Name, Batch No. and Mfg. Name, gross weight, tare weight and net weight of each
container. Record the observations in physical verification record.
5.11 Deface the approved label of the manufacturer on the container, with a black marker pen.
5.12 If Mfg. COA is not received with the consignment, immediately inform to purchase dept.
5.13 Transfer material to the quarantine area. If storage condition of the material is below 25°C transfer
it to RM Store.
5.14 Give the acknowledgement to the transporter; Record all the details in Material Inward Register
(RM/PM).
5.15 Make the GRN in SAP system in MIGO and send mfg. COA to Quality Control Department.
5.16 Raw Material GRN to be made batch wise and for Packing Material GRN is to be made Challan
wise & Product wise.
5.17 Affix “QUARANTINE” Label on each & every container for all Raw Material & Ensure that
manufacturer label or the name of the product should not be covered by the quarantine label.
5.18 Affix quarantine labels 100% on Printed Aluminum Foils.
5.19 For all other packing material affix 25% quarantine label of the total received packs. If more than
100 packs are received, affix 25 nos. quarantine label to the consignment. Remaining containers will be
identified with batch no.
5.20 Sampling of Raw Material and Packing Material will be done by Q.C.
5.21 After sampling, Q.C. Dept shall put sticker as “SAMPLED” adjacent on quarantine labels of
sampled containers.
5.22 After completion of analysis. Q.C person will affix the “APPROVED” or “REJECTED” label on
the “QUARANTINE” label.
5.23 Transfer the material to respective stores after QC analysis:
• If material approved by Q.C. department, Transfer the material to the designated approved storage area.
• If material rejected by Q.C. department, Transfer the material to the rejected room under lock and key.
5.24 All Raw Materials should be stored on pallets or racks in an orderly fashion to permit batch
segregation and First in First out stock rotation.
5.25 All “Approved” packing material product labels shall be stored in their respective lockers under
lock & Key. Ensure that one locker has only one type of label.
5.26 In case of more than one lot /A. R. No., pack the labels in separate poly bags and arrange FIFO
wise in the respective locker.
5.27 Store the “Approved” aluminum foil in the foil storage room under controlled temperature.
5.28 In case of the raw material having specific storage condition, Quarantine & Approved Materials are
kept segregated in a specified area.
PRECAUTIONS
1) Store all goods on pallets item wise and batch wise.
2) Keep some distance between wall & material so as to cleaning can be done easily.
6.0 ABBREVIATIONS
6.1 SOP – Standard operating procedure
6.2 QA – Quality assurance
6.3 QC – Quality control

7. Reporting
 Requisition form, Purchase Order form, Goods return form shall be filled
8. Reference Documents: Nil