SOP for Preparation of Rejection Note

Standard operating procedure to prepare the rejection note for the material rejected by quality control after proper analysis.

1.0 OBJECTIVE

To lay down the procedure for preparation of Rejection Note.

2.0 SCOPE

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY

Officer Quality Control

4.0 ACCOUNTABILITY

Sr. Manager Quality Assurance

5.0 PROCEDURE

5.1 The rejection of any Raw / Packing material based on Quality parameters shall be authorized by Quality Head.
5.2 The rejection note shall be prepared for all rejected materials in the approved proforma.
5.3 The rejection note shall be prepared in a set and one copy shall be given to each of following.
a) Officer Stores
b) General Manager Materials
c) Quality Control Record
5.4 The rejection note shall be authorized by Quality Assurance Head.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 QC: Quality Control
6.4 Dept.: Department
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is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

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