Tag: USFDA guidelines

Poor validation of water purification systems for high-demand operations.

March 25, 2025 Admin

Poor validation of water purification systems for high-demand operations. Poor validation of water purification systems for high-demand operations. Introduction: Water purification systems are integral to pharmaceutical manufacturing, especially in the production of solid oral dosage forms like capsules. The quality of water used directly impacts the safety and efficacy of oral medications. However, poor validation…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Difficulty in maintaining consistent capsule integrity during high-speed packing.

March 25, 2025 Admin

Difficulty in maintaining consistent capsule integrity during high-speed packing. Difficulty in maintaining consistent capsule integrity during high-speed packing. Introduction: In the fast-paced world of pharmaceutical manufacturing, maintaining consistent capsule integrity during high-speed packing can pose significant challenges. Capsules, whether hard or soft gelatin, are popular solid oral dosage forms due to their ease of administration…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Addressing Challenges in Process Validation for Immediate Release Tablets

March 24, 2025 Admin

Addressing Challenges in Process Validation for Immediate Release Tablets Addressing Challenges in Process Validation for Immediate Release Tablets Introduction: Immediate release tablets are a cornerstone in the pharmaceutical industry, known for their rapid disintegration and absorption properties, providing swift therapeutic effects. As the demand for these tablets continues to grow, ensuring their efficacy and safety…

Solid Dosage form, Tablets

Real-Time Monitoring of Granulation Moisture Levels During Wet Granulation

March 23, 2025 Admin

Real-Time Monitoring of Granulation Moisture Levels During Wet Granulation Real-Time Monitoring of Granulation Moisture Levels During Wet Granulation Introduction: In the pharmaceutical industry, the manufacturing of solid dosage forms such as tablets often involves the process of wet granulation. This critical process ensures the homogeneity and compressibility of the drug mixture. One of the most…

Solid Dosage form, Tablets

Poor reproducibility in weight variation data for capsules over storage periods.

March 22, 2025 Admin

Poor reproducibility in weight variation data for capsules over storage periods. Poor reproducibility in weight variation data for capsules over storage periods. Introduction: In the pharmaceutical industry, ensuring the consistency and quality of solid oral dosage forms such as capsules is critical. Capsules, whether hard or soft gelatin, are widely used due to their ease…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Resolving Challenges in Handling Soft Gel Tablets During Packaging

March 22, 2025 Admin

Resolving Challenges in Handling Soft Gel Tablets During Packaging Resolving Challenges in Handling Soft Gel Tablets During Packaging Introduction: Soft gel tablets, often referred to as soft gelatin capsules, are a popular dosage form in the pharmaceutical industry, valued for their ease of swallowing, ability to mask unpleasant tastes, and capability to deliver liquid or…

Solid Dosage form, Tablets

Troubleshooting Failures in In-Process Monitoring for Film-Coated Tablets

March 22, 2025 Admin

Troubleshooting Failures in In-Process Monitoring for Film-Coated Tablets Troubleshooting Failures in In-Process Monitoring for Film-Coated Tablets Introduction: In the pharmaceutical industry, film-coated tablets represent a significant portion of solid dosage forms due to their enhanced stability, ease of swallowing, and aesthetic attributes. The coating process is critical, as it affects the tablet’s performance and patient…

Solid Dosage form, Tablets

Troubleshooting Non-Adherence of Coating Layers in Extended Release Tablets

March 22, 2025 Admin

Troubleshooting Non-Adherence of Coating Layers in Extended Release Tablets Troubleshooting Non-Adherence of Coating Layers in Extended Release Tablets Introduction: In the pharmaceutical industry, extended release tablets play a crucial role in delivering medication over a prolonged period, enhancing patient compliance and therapeutic efficacy. However, one of the persistent challenges in their production is the non-adherence…

Solid Dosage form, Tablets

Preventing Coating Layer Delamination in Extended Release Tablets

March 22, 2025 Admin

Preventing Coating Layer Delamination in Extended Release Tablets Preventing Coating Layer Delamination in Extended Release Tablets Introduction: In the pharmaceutical industry, the development of extended release tablets presents a significant advancement in drug delivery systems. These tablets are engineered to release medication at a predetermined rate, thereby maintaining a consistent drug concentration for an extended…

Solid Dosage form, Tablets

Managing Packing Material Variation for Consistency in Blister Packaging

March 21, 2025 Admin

Managing Packing Material Variation for Consistency in Blister Packaging Managing Packing Material Variation for Consistency in Blister Packaging Introduction: In the pharmaceutical industry, blister packaging serves as a critical component for ensuring the stability and protection of solid dosage forms like tablets. The packaging not only safeguards the medication but also ensures patient compliance and…

Solid Dosage form, Tablets

Troubleshooting Brittleness Failures in Immediate Release Tablets

March 21, 2025 Admin

Troubleshooting Brittleness Failures in Immediate Release Tablets Troubleshooting Brittleness Failures in Immediate Release Tablets Introduction: Immediate release tablets represent a significant portion of the pharmaceutical market due to their convenience and effectiveness in delivering medication rapidly. However, brittleness failures in these tablets can pose substantial challenges, affecting their integrity and therapeutic efficacy. Brittleness, often resulting…

Solid Dosage form, Tablets

Identifying Root Causes of Poor Disintegration in Film-Coated Tablets

March 21, 2025 Admin

Identifying Root Causes of Poor Disintegration in Film-Coated Tablets Identifying Root Causes of Poor Disintegration in Film-Coated Tablets Introduction: Film-coated tablets are a popular solid dosage form in the pharmaceutical industry due to their enhanced stability, ease of ingestion, and ability to mask unpleasant tastes. However, one critical quality attribute for these tablets is their…

Solid Dosage form, Tablets