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Manufacturing Defects in Tablets

The document discusses manufacturing defects in tablets, highlighting the critical importance of quality in pharmaceutical production. It classifies defects into visual, mechanical, and coating issues, identifies root causes, and suggests prevention strategies. Emphasis is placed on adhering to regulatory guidelines and maintaining quality assurance throughout the manufacturing process.

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toneme4974
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19 views16 pages

Manufacturing Defects in Tablets

The document discusses manufacturing defects in tablets, highlighting the critical importance of quality in pharmaceutical production. It classifies defects into visual, mechanical, and coating issues, identifies root causes, and suggests prevention strategies. Emphasis is placed on adhering to regulatory guidelines and maintaining quality assurance throughout the manufacturing process.

Uploaded by

toneme4974
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Manufacturing Defects in Tablets

Understanding Issues in Tablet


Formulation and Production
Your Name
Institution / Organization
Date
Introduction
• • Tablets: solid dosage form for oral
administration
• • Quality is critical in pharmaceutical
manufacturing
• • Goal: Understand common manufacturing
defects, causes, and prevention
Tablet Manufacturing Process
Overview
• • Granulation (Wet/Dry)
• • Blending
• • Compression
• • Coating (if applicable)
• • Packaging
What are Manufacturing Defects?
• • Deviations in physical or chemical properties
• • Occur during production, handling, or
packaging
• • Affect tablet efficacy, safety, and patient
compliance
Classification of Defects
• 1. Visual Defects
• 2. Mechanical Defects
• 3. Coating Defects
• 4. Weight/Content Uniformity Issues
Common Visual Defects
• • Capping: Top or bottom of the tablet splits
• • Lamination: Tablet splits into layers
• • Cracking: Visible fractures on the tablet
Common Mechanical Defects
• • Chipping: Tablet edges break off
• • Sticking & Picking: Material sticks to
punches/dies
• • Hardness Variation: Affects tablet
disintegration
Coating Defects
• • Mottling: Uneven color distribution
• • Blistering: Swelling of the coating
• • Peeling/Flaking: Coating detaches from the
tablet
Weight & Content Uniformity
Defects
• • Caused by uneven fill or poor powder flow
• • Impacts dosage accuracy and efficacy
• • Requires regular in-process testing
Root Causes of Defects
• • Poor formulation (e.g., granule size,
moisture)
• • Equipment issues (e.g., compression speed,
die wear)
• • Environmental factors (e.g., humidity,
temperature)
• • Operator error or process variability
Prevention & Control Strategies
• • Conduct pre-formulation studies
• • Validate all processes
• • Perform in-process quality checks (IPQC)
• • Maintain and calibrate equipment regularly
• • Train manufacturing personnel
Regulatory Perspective
• • Follow Good Manufacturing Practices (GMP)
• • Adhere to FDA/WHO/ICH guidelines
• • Implement robust QA and QC systems
Case Studies / Examples
• • Example 1: Capping issue due to insufficient
binder
• • Example 2: Weight variation due to poor
granule flow
• • Include visuals or data if applicable
Summary
• • Reviewed major types of tablet defects
• • Identified root causes and prevention
techniques
• • Emphasized importance of quality assurance
in pharma
Q&A
• • Thank you!
• • Questions and Discussion
References
• • USP Guidelines
• • WHO GMP Handbook
• • Pharmaceutical Manufacturing Textbooks

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