Wednesday , November 25 2020
Home / Warehouse / SOP / Handling of Obsolete Rejected and on line rejections of raw materials

Handling of Obsolete Rejected and on line rejections of raw materials

: To lay down a procedure for handling of Obsolete / Rejected and on line rejections of raw materials.

  • Scope: This procedure is applicable to warehouse of formulation plant for Pharmaceutical Company Name).
  • Responsibility:Store personnel shall be responsible for implementation of this SOP.
  • Accountability:Concerned Department Head and QA Head shall be accountable for implementation of this SOP.
  • Abbreviations and Definitions

Obsolete :The raw materials which are either expired or are not in a state of any further use.

Rejected :The raw materials which do not comply with specifications.

Line Rejection : Approved material (Rejected) during production for specified Reasons

RM         : Raw Material

GRN        :Goods receipt note 

  • Procedure:
    • Rejection of RM at the time of receipt:
      • At the time of receipt of raw material consignments, if found any damages in materials, Warehouse personnel itself authorized to reject the same at unloading way with the concurrence of Officer or above warehouse.
      • After rejection materials shall be kept in rejected storage area with a label ‘REJECTED’ duly filled and signed. This shall be sent back to the supplier after proper documentation.
    • Rejection of raw materials which are approved and issued for production but are termed as line rejections as they are not able to be used in production for specified reasons:
      • When ‘line rejections note’ as per Annexure No. WHSG007/A01 (format No. WHSG007/F01 is received from production, Officer Warehouse shall verify the quantity and reason for ‘Line Rejection’ and keep all line rejections in Rejected Area till a proper investigation is done by Purchase and Quality Control department.
      • If the line rejected material is to be returned back to the vendor, the same shall be done with required documentation.
      • If the material in is no further use the same shall be labelled as ‘REJECTED’.
    • Rejection of Raw Materials at the time of periodic retest:
      • The material (s), if rejected at the time of retesting, shall be kept in Rejected Raw Materials Storage area with a label ‘REJECTED’.
      • Destruction note for ‘REJECTED’ raw material(s) shall be made by Officer Warehouse for taking the approval from Head- warehouse, Manager – Q.A. and GM-Formulation as per Annexure WHSG007/A02 (Format No. WHSG007/F02) ‘Destruction Note for Rejected Raw / Packaging Materials’.
    • Handling of Obsolete Raw Materials:
      • Rejected material which are lying in warehouse and are expired or not in condition for further use, shall be destroyed as obsolete Materials after taking approval from Head – warehouse, Manager – Q.A. and GM – Formulation on “Destruction Note for Obsolete Raw/Packaging Materials” as per Annexure WHSG007/A03 (Format No. WHSG007/F03).
      • Proper entries shall be made in ‘Raw Materials Stock Register’ and information shall be sent to Excise department (if applicable) to get the entries done in their respective records for the material to be destroyed.
      • After counter checking the materials shall be destroyed in presence of Head warehouse, Quality Assurance, if required.
      • After destruction the authorized personnel shall sign the destruction note.
  • Forms and Records (Annexures)
    • Line rejection note –  Annexure-I
    • Destruction note for rejected raw / packaging materials – Annexure-II
    • Destruction note for obsolete raw /  packaging materials – Annexure-III
  • Distribution
    • Master copy – Quality Assurance
    • Controlled copies – Quality Assurance, Production, Stores.

 History

Date      Revision Number               Reason for Revision
         –                     –                      New SOP

                                                         Annexure – I

Document No.: Product Name: Batch Size:
Batch No.: Mfg. Date: Exp. Date:

 

Material

Code

Material

Description

A.R. No. Unit Qty.

Issued

Qty.

Rejected

            

Reason for Rejection:

Prepared by: Checked by: Received by:
Production Dept. IPQA Warehouse

                                                  Annexure – II

GRN No.: GRN date:
Material name Material code:
Vendor’s name: Invoice no. & date:
Qty. received: Received date:
A.R. No.: Qty. in stock:
Rejected qty. Value of rejected material:
Reason of rejection:

 

The above material is not suitable for use, therefore to be destroyed.

Prepared by: Verified by: Approved by: Authorized by:
Officer Warehouse Head – Warehouse Manager – Q.A. GM – Formulation

 

Material destroyed on_________________ in presence of ___________________________

Quality Assurance____________________Warehouse______________________________

                                                       Annexure – III

GRN No.: GRN date:
Material name Material code:
Vendor’s name: Invoice no. & date:
Qty. received: Received date:
A.R. No.: Qty. in stock:
Obsolete qty. Value of obsolete material:
Reason of obsoletion:

The above material is not suitable for use, therefore to be destroyed.

Prepared by: Verified by: Approved by: Authorized by:
Officer Warehouse Head – Warehouse Manager – Q.A. GM – Formulation

 

 

 

For More Pharma Updates Visit –https://pharmaguidances.com

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also

Reconciliation of raw materials & packaging materials

Reconciliation of raw materials & packaging materials Objective:To provide a procedure for reconciliation of raw …