SOP for Tablet Inspection : Pharmaceutical Guidelines

SOP for Tablet Inspection

Standard operating procedure to inspect the tablets during manufacturing.

1.0 OBJECTIVE

To lay down the procedure for Tablet Inspection.

2.0 SCOPE

This SOP shall be applicable for Tablet Inspection in the Production area.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 PROCEDURE

5.1 Production person shall ensure the cleanliness of machine & area and ‘CLEANED’ label on it.
5.2 Before taking the tablet in the area, get the line clearance from Q.A. person by writing the status label with Product Name, Batch Details to machine & area.
5.3 Production person shall ensure that proper labeling of the rejected tablet, Good tablet & Recovery container.

5.4 FOR UNCOATED TABLETS

5.4.1 Dedust the tablets with the help of a perforated tray.
5.4.2 Inspect the dedusted tablets for any visible foreign matter, black specks and segregate them from good tablets. These tablets should be treated as ‘Rejected Tablets’.
5.4.3 Also check for tablet defects such as Chipping, Capping, mottling, Sticking, Tablets with poor embossing, and broken tablets of any other defects as instructed by the Pharmacist and collect in recover container. These tablets should be treated as Utilisable residue.
5.4.4 Collect the good tablets in double polythene bags contained in suitable container weigh and label it properly.
5.4.5 Destroy the rejected tablets as per Standard Operating Procedure.
5.4.6 Destroy the fines obtained after dedusting by soaking in water.

5.5 FOR COATED TABLETS

5.5.1 Inspect Coated Tablets for black specks, extraneous matter, color variation, broken tablets etc. These tablets should be treated as ‘Rejected Tablets’.
5.5.2 Transfer the inspected tablets to double polythene bags placed inside suitable airtight containers, weigh and label it properly.
5.5.3 Destroy the rejected tablets as per SOP for destruction of tablets in the presence of Q.A. person.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The 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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