SOP For Visual Inspection Of Tablets

Standard Operating Procedure for visual inspection of core and coated tablets.

1.0 Purpose

The purpose of this SOP is to develop a standard procedure for checking or inspection of tablets.

2.0 Scope

This SOP is applicable to the procedure used for sorting or visual inspection of core and coated tablets in the tablet manufacturing area.

3.0 Responsibility

3.1 Visual inspection team is responsible for sorting or inspection of core and coated tablets.

3.2 Production Pharmacist is responsible for the implementation of this SOP.

3.3 The HOP is responsible for ensuring the implementation of the current SOP.

3.4 Q.A Officer monitors the compliance of this SOP.

4.0 Procedure

4.1 Ensure that the inspection room is properly cleaned and labeled.

4.2 The inspection supervisor shall bring the batch of tablets to be inspected in the inspection room and check the weight of the batch as per BMR.

4.3 The inspection supervisor shall take line clearance from the Production and Quality Assurance officer.

4.4  For Core Tablets

4.4.1 The inspection supervisor shall spread a clean polythene over the stainless steel inspection table.

4.4.2 Open the drum of core tablets and remove tablets from the drum with a perforated stainless bowl.

4.4.3 Shake the tablets in a bowl over a stainless tray to dedust the tablets and collect the powder in a stainless steel tray.

4.4.4 Spread the dedusted tablets over the polythene and inspection team shall check the core tablets for following defects 

  • Broken tablets
  • Black particles 
  • Capping, lamination 
  • Sticking, picking 
  • Low hardness,rough surface 
  • Poor embossing, mottling 

4.4.5 Remove the above-mentioned defective tablets from good tablets and place the rejected tablets in a separate polythene labeled with rejected tablets.

4.4.6 Transfer the good tablets in a cleaned drum having a polythene bag and labeled with good tablets.

4.4.7 At the end of the inspection process weigh the dedusted powder, rejected tablets and waste them as per WDN (waste disposal note).

4.4.8 Mention the weight of good tablets,rejected tablets and dedusted powder in the BMR.

4.4.9 The production pharmacist shall reconcile as per the weight provided.

4.4.10 Transfer the good tablets to the inprocess storage area.

4.4.11 Record the inspection or tablet sorting activity in the logbook.

4.5 For Coated Tablets 

4.5.1 Place the coated tablets over the polythene bag and inspect the tablets for following

  • Color Variation 
  • Black spots, chipping 
  • Sticking, picking 
  • Twinning, broken tablets 
  • Logo filling,rough surface 

4.5.2 Weight the rejected and good tablets and reconcile as per above mentioned procedure.

4.5.3 Waste the rejected tablets by generating WDN.

4.5.4 Transfer the good tablets to the inprocess storage area.

4.5.6 Record the inspection or tablet sorting activity in the logbook.

5.0 Abbreviations

5.1 SOP: Standard Operating Procedure

5.2 BMR: Batch Manufacturing Record

5.3 QA: Quality Assurance

5.4 HOP:Head Of Production.

Also, Read

  1. SOP For Uphill Deduster and Metal Detector
  2. SOP for Compression Machine
  3. Temperature and Humidity in Store
  4. SOP For housekeeping Of Stores 
  5. SOP For Reconciliation Of Raw & Packaging Material