Receiving Inspection of Incoming Materials

1.0     Purpose

1.1        To describe the procedure to ensure that all incoming materials with it’s related documents  are inspected properly at the time of receive to find out the conformity with the declaration as well as to notify the physical conditions of materials .

2.0     Scope

2.1     The procedure is applicable for all incoming raw, packaging and ancillary materials of "NAME"   Pharmaceuticals Ltd.

3.0     Responsibility

3.1        Store Officer is responsible for receive and ensure receiving inspection of incoming materials.

3.2        Store In-Charge is responsible for proper execution of the SOP.

 

4.0      Abbreviations and Definitions

4.1      Raw Materials: Any substance of defined specification which is directly used for manufacturing of a

product.

4.2     Packaging Materials: Any materials including printed material used in the packaging of the    

 pharmaceuticals product, including any outer packaging used for transportation or shipment packaging materials

are referred to as primary or secondary according to whether or not they  are intended to be in direct or indirect

contact with the product.

4.3   Ancillary Materials: Miscellaneous packaging materials like Test Request pad, Adhesive tape, Requisition slip etc.

4.4   GRN     : Goods Received Note

 

5.0       Materials and Equipment

5.1        Not Appreciable

 

6.0     Precaution / Health and Safety Considerations

6.1        All materials shall be handled carefully to avoid contact with any contaminants.

6.2        Container that dirty must be cleaned. Unnecessary outer packing materials must be cleaned.

7.0    Procedure

7.1        The delivery challan (local) in duplicate and invoice copy (for imported material) shall be   received during receiving the materials.

7.2        The certificate of analysis (COA) and other related document of the materials shall also be  received during receiving of materials.

7.3        Materials to be segregated batch wise/lot wise and the detail to be entered in the GRN.

7.4        The material to be received will be checked whether they are properly labeled or not and whether the packaging condition is good or not.

7.5        The related documents will be verified with the physical findings and following information will be recorded in the GRN.

                      I.        Name of Material

                     II.        Name of the Supplier

                   III.        Name of the Manufacturer

                   IV.        Country of origin

                    V.        Challan / Invoice no

                   VI.        Quantity

                  VII.        Supplier’s Batch / Lot no

                VIII.        Sound and damage quantity

                   IX.        Manufacturing. Date and Expiry  Date

                    X.        Pack size

                   XI.        Number of pack

Note : Mfg. Date and Exp. Date is not required for packaging materials.

7.6          The containers shall be checked for integrity of package and seal, consignment corresponds to the order and supplier’s label. Any gap in information regarding Mfg. Date, Exp. Date, Batch no/ lot no, damaged condition etc. will be informed to commercial dept. in written with a copy to QA department for taking necessary action with the concern.

7.7        A received and duly signed copy of delivery challan will be sent to commercial department.

7.8        Filled GRN along with the Certificate of analysis and Invoice copy will be given to QC department as sampling intimation and for their necessary action.

7.9        Documents would be preserved in such a way that activities concerning the receiving  inspection can be made available for product identification and traceability after one year of  expiration.

 

8.0      Reference Document 

8.1       In-house

 

9.0       Annexure 

9.1        Annexure-I         : Materials Receiving Checklist

9.2        Annexure-II        : Flow Chart for Incoming Materials

 

10.0    Revision History 

Version No.	Brief Reason for the Revision	Effective Date	Remarks
01.	New

 

 

 

11.0   Training 

11.1      Training on this SOP is required for respective operators and Executives of Warehouse.