SOP for Preparation of Rejection Note : Pharmaceutical Guidelines

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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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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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