AISSMS COLLEGE OF PHARMACY,

PUNE

PROCESS
VALIDATION OF
TABLETS
Presented by: Guided by:
Anushriya Thakur Dr. M. R Bhalekar1
(Pharmaceutics)
 01 Introduction to Process Validation
02 Stages of Process Validation

Content 03 Step 1: Process Design of

04 Step 2: Process Qualification of
Tablets
Outline 0 Tablets
0
In-Process Controls for Tablets
5 Step
(IPCs)3: Continued Process Verification
0
6 Process
(CPV) Validation Strategy for Tablets
0
7 Process Overview
0 Troubleshooting Common Issues
8
1
9 Conclusion & References
0
2
 WHAT IS PROCESS
VALIDATION?
It is the process of establishing documented evidence that
a specific procedure, process, or activity consistently
produces a product meeting its predetermined
specifications and quality attributes.

3
 PHARMACEUTICAL TABLET PRODUCTION
SIGNIFICANCE FOCUS

• Essential in the pharmaceutical • In tablet production, process

industry to ensure patient validation helps in identifying and
safety and product efficacy. controlling variables that can
affect product quality.
• Regulatory agencies require
robust validation processes to • It ensures that the tablets produced
minimize risks associated with are uniform in dosage, appearance,
drug manufacturing. and performance.

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 STAGES OF PROCESS
VALIDATION

01 This initial stage involves defining the

process parameters and specifications,
ensuring product quality.

02 In this stage, the process is tested and

validated to confirm that it operates
within the defined parameters. It
includes IQ, OQ and PQ
03 This final stage involves ongoing
monitoring and verification of the
process to ensure it remains in a state
of control. 5
 STEP-1: PROCESS
DESIGN
• Understanding the formulation of tablets.
• Pre-formulation and formulation studies.
• Risk assessment.
• Identification of Critical Process
Parameters (CPPs).

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 PRE-FORMULATION
STUDIES

• API and excipient compatibility.

• Powder flow properties.
• Moisture content and hygroscopicity.
• Particle size distribution.

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 FORMULATION
DEVELOPMENT
• Selection of excipients (binders,
disintegrants, lubricants, etc.).
• Granulation method (wet vs. dry
granulation).
• Lubrication optimization.
• Tablet core and coating design.

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 IDENTIFICATION OF CRITICAL
PROCESS PARAMETERS (CPPS)

1.Granulation
• Binder concentration, particle size.
1.Compression
• Hardness, force, dwell time.
1.Coating
• Spray rate, air temperature.

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 IDENTIFICATION OF CRITICAL
QUALITY ATTRIBUTES (CQA)

1.Tablet weight
uniformity.
2.Disintegration time.
3.Dissolution rate.
4.Friability and hardness.
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Step 2 -
Process
Qualification
(PQ)
Installation Operational Performance
Qualification Qualification Qualification (PQ)
(IQ) (OQ)

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INSTALLATION QUALIFICATION (IQ)

• Ensures equipment is installed

correctly.
• Verification of machine
components.
• Calibration of instruments.
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OPERATIONAL QUALIFICATION (OQ)

• Verifying equipment operates within

set parameters.
• Testing under different loads and
speeds.
• Safety and alarm system checks.
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PERFORMANCE QUALIFICATION (PQ)

• Running full-scale batches under

commercial conditions.
• Data collection for validation.
• Testing for consistency and
reproducibility.
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VALIDATION BATCHES

• Three consecutive successful batches required.

• Data must demonstrate consistency and
reproducibility.
• Real-time monitoring of CPPs and CQAs.

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In-Process Controls (IPCs)

• Real-time monitoring of parameters.

• Common IPC tests:
⚬ Weight variation
⚬ Hardness & friability
⚬ Thickness & disintegration

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Step 3 -
Continued Pre-clinical Stage
Ensures
Process ongoing control
of the
Verification validated
process.
(CPV)
Ensure batch- Monitoring of
to-batch critical
consistency. parameters.

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 PROCESS VALIDATION
STRATEGY
• Raw Material Variability: Include different lots of raw materials, such
as active drug substances and major excipients.
• Batch Scheduling: Run batches in succession on different days and
shifts.
• Equipment and Facilities: Manufacture batches in designated
commercial production equipment and facilities.
• Critical Process Variables: Set within operating ranges without
exceeding control limits during operation.
• Output Responses: Ensure they are within finished product 18
specifications
 PROCESS OVERVIEW

DRYING &
DISPENSI SIFTIN GRANULATI SIZING
NG G ON

IN-PROCESS CHECKING,
PACKING, FINAL COMPRESSIO LUBRICATION
PRODUCT ANALYSIS, AND N
RELEASE
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 DISPENSIN
•G
Cleanliness: Ensure the dispensing booth is clean as
per SOP.
• Equipment Calibration: Verify balance calibration
and check for zero error.
• Material Verification: Confirm materials are issued
as per the Batch Processing Report.

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 SIFTING
• Environmental Conditions: Record temperature
and relative humidity (25 ± 2°C & RH 45 ± 5%).
• Equipment Cleanliness: Ensure all equipment and
parts are visually clean.
• Sieve Integrity: Check and record the integrity of
sieves before and after sifting.

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GRANULATION
• Mixing: Add ingredients into the mixer and mix for 5
minutes at a slow speed.
• Sampling: Collect samples at 3, 5, and 7 minutes from
five different places for uniformity analysis.
• Granulating Solution: Add and homogenize at a slow
speed for about 10 minutes.
• Moisture Content: Check the Loss on Drying (LOD) in
wet granules.
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 DRYING AND
•SIZING
Drying Parameters: Set appropriate temperature
and time to achieve desired moisture content.
• Sizing: Mill dried granules to uniform particle size.

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LUBRICATION
• Blending: Mix granules with lubricants for a
specified time.
• Uniformity: Ensure even distribution of lubricants.

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COMPRESSION
• Machine Setup: Ensure the compression machine
is clean and calibrated.
• Tablet Parameters: Set weight, hardness, and
thickness specifications.
• In-Process Checks: Monitor tablet weight
variation, hardness, and appearance.

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 IN-PROCESS
•CHECKING
Sampling: Collect samples at regular intervals.
• Testing: Perform tests for weight variation,
hardness, friability, and disintegration.
• Documentation: Record all observations and
results.

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PACKAGING
• Packaging Materials: Verify materials against
specifications.
• Line Clearance: Ensure no remnants from previous
batches.
• Labeling: Check accuracy and legibility of labels.

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 TROUBLESHOOTI
NG
COMMON ISSUES
Friability Coating defects:
Weight
failure: Modifying spray
variation:
Adjusting rate & drying
Adjusting
compression conditions.
powder flow
force.
rate.

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 CONCLUSI
• ON
Process validation is a crucial step in pharmaceutical manufacturing, ensuring
that every tablet meets safety, efficacy, and quality standards.

• A validated process minimizes risks, reduces batch failures, and ensures

regulatory compliance with FDA, ICH, WHO, and GMP guidelines.

• It involves a structured approach, including Process Design, Process

Qualification, and Continued Process Verification, to maintain
consistency and compliance.

• By implementing robust process validation, manufacturers can guarantee

high-quality, safe, and effective pharmaceutical products.
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 REFERENC
ES
• Verma V, Nautiyal U, Kumar MS, Kant C. Process validation of
tablets: an overview. Asian Pac J Health Sci. 2014;1(1):31-38.
• Pharmaceutical Process Validation An International Third
Edition, Volume 123, Revised and Expanded; By Fra. R. Berry
and Robert A. Nash , chapter 5, Page No. 159- 180
• U.S. Food and Drug Administration (FDA). Process validation:
General principles and practices. Rockville, MD: U.S.
Department of Health and Human Services, Food and Drug
Administration; 2011 30
THANK
YOU.
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