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1.0 OBJECTIVE
To lay down the procedure for collection, storage and analysis of stability samples of finished products.
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 The responsibility for collection, storage and analysis of stability samples and recommendations (if any) shall be followed as per flow chart.
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SOP for Stability Studies of Finished Goods : Pharmaceutical Guidelines https://www.pharmaguideline.com/2008/03/sop-for-procedure-for-stabilit...
5.6.3 Decision on recalling the affected batches and /or along with other batches produced during the same time shall be taken by GM-Technical
Services in consultation with Chairman & Managing Director & Vice Chairman.
6.0 ABBREVIATIONS
6.1 SOP: Standard operating procedure
6.2 QA: Quality assurance
6.3 QC: Quality control
6.4 Dept.: Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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