PharmaNewsBD: Tablet Processing Checklist, designed to support manufacturers in ensuring consistent quality, regulatory compliance, and operational efficiency across all stages of tablet production.

Process validation for the tablet manufacturing process

• Is the reason for the presence of each ingredient in the formula provided?
• Are the normal properties of each ingredient mentioned? Are these properties used or changed in the formula under study.
•  Are the characteristics of the initial powder blends, the wet and/or dry granulations and the final blends mentioned?
• Is the density – ‘loose’ and ‘tap’ determined?
• Is the particle size distribution determined?
• Is the surface area determined?
• Are the flow properties, e.g. contact angle determined?
• Are the moisture content, if applicable determined?
• Are all the processing steps needed for the initial scale-up determined?
• Is the optimal blending time-based MFR.
• Are the tests used to assess the uniformity of the final product determined? Content uniformity, weight variation testing

The checklist provides a step-by-step framework covering the full tablet manufacturing workflow, from raw material handling to final packing, in alignment with WHO GMP and Bangladesh DGDA standards.

GMP-Based Audit Checklist (Tablet Manufacturing)

A. Facility & Premises

• HVAC qualification & pressure differentials recorded

• Temperature & humidity logs maintained

• Cleanroom classification maintained

• Pest control records available

• Proper material & personnel flow

• Segregation of approved/rejected materials

B. Equipment

• Equipment IQ/OQ/PQ completed

• Calibration status within validity

• Preventive maintenance schedule followed

• Cleaning validation available

• Status labels attached (Clean/In Use/Under Maintenance)

C. Documentation

• Approved Master Batch Record (MBR)

• Batch Manufacturing Record (BMR) completed

• Logbooks updated

• Deviation handling system in place

• Change control records maintained

• SOPs current & controlled

D. Raw Materials

• Approved vendor list available

• COA verified

• Quarantine & release system followed

• Sampling procedure compliant

E. In-Process Controls

• Blend uniformity performed

• LOD within limit

• Weight variation controlled

• Hardness & friability tested

• Disintegration & dissolution performed

F. Personnel

• Training records available

• GMP training up-to-date

• Gowning procedure followed

• Health monitoring records maintained

G. Quality Control

• Analytical methods validated

• Stability program running

• OOS procedure implemented

• Retention samples stored properly

Pre-Operation

• Line clearance completed

• Equipment cleaned & labeled

•  Calibration verified

• MBR available

Dispensing

•  Materials verified

• Weights cross-checked

• Entries recorded

Granulation

• Mixing time recorded

• Binder addition recorded

• Granule consistency checked

Drying

• Temperature recorded

• LOD tested

• Within specification

Blending

• Lubricant added last

• Mixing time recorded

• Blend uniformity passed

Compression

• Tooling inspected

• Weight variation within limit

• Hardness within limit

• Friability < 1%

• Disintegration within limit

Post-Operation

• Reconciliation completed

• Cleaning performed

• BMR completed

Excel-Format Checklist Template (Column Structure)

You can directly paste this into Excel:

Rotary Tablet Compression Machine Specific Checklist

Machine Setup

• Punch & die inspected

• Turret cleaned

• Feeder alignment checked

• Pre-compression force set

• Main compression force set

• Fill cam adjusted

• Weight control calibrated

During Operation

• RPM recorded

• Output per hour monitored

• Tablet weight every 15–30 min

• Hardness monitored

• Thickness monitored

• Noise/vibration abnormality check

• Lubrication system functioning

Troubleshooting Check

• Capping observed?

•  Lamination?

• Sticking/picking?

• Double impression?

Post-Run

• Tooling removed safely

• Cleaning completed

• Logbook updated

• Reconciliation done

QA Audit Checklist for Regulatory Inspection

Documentation Review

• MBR approved & controlled

• BMR complete & reviewed

• Deviations closed

• CAPA implemented

• Change control documented

Validation

• Process validation report

• Cleaning validation report

• Equipment qualification

• Analytical method validation

Data Integrity

• No overwriting

• Corrections signed & dated

• Audit trail review performed

• Electronic system validated

Quality Systems

• Complaint handling system

• Recall procedure

• Supplier qualification

• Stability study program

Regulatory Compliance

• cGMP compliance (WHO/FDA/EU)

• Batch traceability

• Training matrix available

Key Features of the Tablet Processing Checklist

1. Raw Material Dispensing

   • Verification of material identity, quantity, and batch number

   • Compliance with approved Master Batch Record (MBR)

   • Weighing and documentation procedures

2. Sifting, Milling, and Granulation

   • Mesh size and sieve integrity checks

   • Wet and dry granulation process monitoring

   • Moisture content and granule consistency checks

3. Drying

   • Temperature and duration monitoring

   • Loss on drying (LOD) verification

   • Uniformity checks

4. Blending and Lubrication

   • Blend uniformity assessment

   • Correct sequence and timing for lubricant addition

5. Compression

   • Tablet press setup and tooling inspection

   • In-process checks: weight, thickness, hardness, friability, disintegration

   • Monitoring for capping, lamination, sticking, or picking

6. Coating (If Applicable)

   • Coating solution preparation

   • Pan speed, spray rate, and temperature control

   • Weight gain monitoring and visual inspection

7. Inspection and Packing

   • Visual and mechanical inspection

   • Metal detection

   • Packaging material verification and batch coding

8. Cleaning and Documentation

   • Post-process cleaning and line clearance

   • Complete record-keeping for regulatory compliance