SOP for Re-analysis of Raw Material : Pharmaceutical Guidelines

SOP for Re-analysis of Raw Material

Standard operating procedure to re-analyze and record the raw material after the retest date.

1.0 OBJECTIVE

To lay down the procedure for reanalysis of raw material.

2.0 SCOPE

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY

Supervisor Quality Control

4.0 ACCOUNTABILITY

Sr. Manager Quality Assurance

5.0 PROCEDURE

5.1 All active and inactive materials shall be reanalyzed as per following schedule.
i) Enzymes 6 months ii) Active 12 months iii) Inactive 24 months
5.2 Stores personnel shall inform the material due for retesting every month to Quality Control.
5.3 The quality control shall move the Material to the UNDERTEST area and shall Sample the material. Containers shall be labeled as "UNDERTEST".
5.4 Complete checks as per Specifications shall be carried out.
5.5 If Material is found to be complying to Specifications, the “APPROVED” slip showing new assigned control number shall be posted on the containers, and material shall be moved to the designated storage area.
5.6 Sampling sheet and analytical report shall be prepared.
Related: SOP for Sampling of Raw Material

5.7 Record

An Entry register shall be maintained, and each material re-analyzed shall be entered therein. A fresh Control Number shall be allotted to the reanalyzed material. A report showing test protocol applied and results obtained shall be prepared.

6.0 ABBREVIATION

6.1 SOP: Standard Operating Procedure





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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