Learn GMP, CAPA and
Validation with Certificate
ENROLL

WH002: SOP FOR RECEIPT, VERIFICATION, IDENTIFICATION, AND INITIAL HANDLING OF RAW MATERIALS, PACKAGING MATERIALS, AND FINISHED GOODS

1.0 OBJECTIVE:
1.1 This SOP shall define the procedure for receipt, verification, identification, and initial handling of raw materials, packaging materials, and finished goods in the warehouse to ensure compliance with Good Manufacturing Practices and to prevent mix-ups, damage, or unauthorized use.

2.0 SCOPE:
2.1 This SOP shall be applicable to the receipt of:
2.1.1 Raw materials
2.1.2 Primary and secondary packaging materials
2.1.3 Finished goods received from production

2.2 This SOP shall apply to Raw Material Warehouse, Packaging Material Warehouse, and Finished Goods Warehouse.

3.0 RESPONSIBILITIES:
3.1 Warehouse In-Charge: shall ensure proper receipt and storage of materials/products.

3.2 Stores Personnel: shall perform receipt activities as per this SOP.

3.3 Quality Assurance (QA): shall review discrepancies and authorize material status.

4.0 DEFINATIONS:
4.1 Receipt: Receipt is the controlled process of accepting materials or finished goods into the warehouse after verification against approved documents and physical condition.

4.2 Quarantine Status: Quarantine status is the identification assigned to materials or finished goods that have been received but not yet approved by the Quality Assurance department and therefore shall not be used or dispatched.

4.3 Delivery Challan: Delivery challan is the supplier or production document accompanying materials or finished goods that provides shipment and quantity details.

5.0 PROCEDURE:
5.1 Pre-Receipt Requirements:
5.1.1 Receipt of materials or finished goods shall be carried out only during authorized working hours.

5.1.2 Adequate space shall be available in the designated receiving area before unloading.

5.1.3 Environmental conditions in the receiving area shall be suitable to prevent deterioration of materials.

5.2 Receipt of Raw Materials and Packaging Materials:
5.2.1 All incoming raw materials and packaging materials shall be received only against:
5.2.1.1 Approved Purchase Order
5.2.1.2 Supplier Delivery Challan
5.2.1.3 Each consignment shall be checked for:
5.2.1.4 Correct material name
5.2.1.5 Supplier name
5.2.1.6 Batch/Lot number
5.2.1.7 Quantity received
5.2.1.8 Container integrity and cleanliness

5.2.2 Any visible damage, leakage, or discrepancy shall be recorded and immediately reported to QA.

5.2.3 Accepted consignments shall be labeled with “UNDER QUARANTINE” status.

5.2.4 Materials shall be transferred to the designated quarantine area.

5.3 Receipt of Finished Goods:
5.3.1 Finished goods shall be received only from authorized production areas.

5.3.2 The following shall be verified:
5.3.2.1 Product name
5.3.2.2 Batch number
5.3.2.3 Quantity packed
5.3.2.4 Packaging integrity

5.3.3 Finished goods shall be stored in the finished goods area.

5.4 Documentation of Receipt:
5.4.1 Each receipt activity shall be recorded in the respective Material Receipt Register / Finished Goods Receipt Register.

5.4.2 Records shall include:
5.4.2.1 Date of receipt
5.4.2.2 Material/Product name
5.4.2.3 Batch/Lot number
5.4.2.4 Quantity received
5.4.2.5 Supplier / Production reference
5.4.2.6 Receiver’s signature

5.5 Handling of Discrepancies:
5.5.1 Any discrepancy related to quantity, identity, or physical condition shall be documented.

5.5.2 Discrepant materials or goods shall be segregated and clearly identified.
5.5.3 QA shall assess the discrepancy and decide further action as per deviation management procedures.

5.6 Transfer to Storage:
5.6.1 After receipt and labeling, materials and finished goods shall be transferred to their respective quarantine storage locations.

5.6.2 Materials shall not be issued, sampled, or dispatched without QA authorization.

5.7 Precautions:
5.7.1 Materials shall not be kept directly on the floor.

5.7.2 Mixing of different materials or batches during receipt shall be avoided.

5.7.3 Only authorized personnel shall be allowed in the receiving area.

5.8 Deviation:
5.8.1 Any deviation from this SOP shall be documented and investigated.

5.8.2 Corrective and preventive actions shall be initiated where required.

5.9 Training:
5.9.1 All warehouse personnel involved in receipt activities shall be trained on this SOP before performing independent operations.

5.9.2 Refresher training shall be conducted periodically.

6.0 REFERENCE:
6.1 WHO TRS 961, Annex 2
6.2 WHO Good Storage Practices
6.3 EU-GMP Part I, Chapter 3 & Chapter 5
7.0 RECORDS:
Sr No. Title Document No.
1 Material Receipt Register F/WH002/001 – 00
2 Finished Goods Receipt Register F/WH002/002 – 00
3 Discrepancy / Damage Record F/WH002/003 – 00

8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01

Search by categories

Read more posts

WH006: SOP FOR ISSUANCE AND DISPATCH CONTROL

1.0 OBJECTIVE: 1.1 This SOP shall define the procedure for controlled issuance of materials to production and controlled dispatch of finished goods to ensure traceability,

WH005: SOP FOR HANDLING AND MOVEMENT OF MATERIALS

1.0 OBJECTIVE: 1.1 This SOP shall describe the procedure for safe handling and controlled movement of materials and finished goods to prevent mix-ups, contamination, damage,

WH004: SOP FOR FIRST IN FIRST OUT (FIFO) AND FIRST EXPIRY FIRST OUT (FEFO)

1.0 OBJECTIVE: 1.1 This SOP shall describe the procedure for implementation and control of First In First Out (FIFO) and First Expiry First Out (FEFO)