SOP for Retesting of Raw Materials : Pharmaceutical Guidelines

SOP for Retesting of Raw Materials

Standard operating procedure to retest the Raw Material stored in appropriate storage conditions.

1.0 OBJECTIVE

To lay down a procedure for retesting of Raw Materials.

2.0 SCOPE

This SOP shall be applicable for retesting of Raw Materials at Stores Department.

3.0 RESPONSIBILITY

Stores Officer/Q.C. Officer

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Every first week of the month, store person shall prepare the
5.2 Handover the one copy of the statement to Quality Control Department for information.
5.3 Transfer the material due for retest to respective “Quarantine” area, print and affix the “Quarantine” label on all containers/packs.
5.4 On release of the material, Quality Control shall affix the “Approved” label on all the containers/packs.
5.5 Transfer the containers/packs from “Quarantine” to respective “Approved” material area.
5.6 Note down the new retest date of materials in bin card.
5.7 In case any material not complies for retesting, QC personnel shall block the above stock from” Quality Inspection” to “Blocked” location and rejected label shall be affixed on all containers/packs of the consignment.
5.8 Transfer the rejected containers/packs to “Rejected Material Store” for further disposal after authorization from Unit Head and QA Head.

6.0 ABBREVIATIONS

6.1 SOP – Standard operating procedure
6.2 QC – Quality control
6.3 QA – Quality assurance





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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