1.0 OBJECTIVE:To lay down the procedure for sampling of Finished product.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Assurance Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.1 For Liquids Orals:5.1.1 The Packing department shall inform the start of packing operations of the batch to QA person.
5.1.2 The QA person shall collect the sample from the packing line.
5.1.3 The quantity of the sample shall be such as to enable complete analysis of product at least twice.
5.1.4 Sampling of products for analysis, from the packing section shall be as per master document.
5.1.5 Collect the sample on initial, middle and final stage of packing operation.
5.2 For Tablets/Capsules:5.2.1 Final sample for the Finished product shall be collected on initial, middle and final stage of blistering / stripping / packing by QA person.
5.2.2 Sampling of products for analysis, from the packing section shall be as per master document.
5.2.3 Finished Product sampling should be done online as required in the product specification, preferably after approximately 50% of bulk is packed.
Related: Procedure for Line Clearance Before Commencing any Manufacturing Operation
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 pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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