Tag: USFDA guidelines

Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets

March 4, 2025 Admin

Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets Introduction: In the realm of pharmaceutical manufacturing, maintaining optimal environmental conditions is crucial to ensuring product quality and efficacy. One significant aspect is humidity control, especially when it comes to the production of film-coated tablets….

Solid Dosage form, Tablets

Optimizing Stability Testing Conditions for Hygroscopic Tablets

March 4, 2025 Admin

Optimizing Stability Testing Conditions for Hygroscopic Tablets Optimizing Stability Testing Conditions for Hygroscopic Tablets Introduction: Hygroscopic tablets, known for their moisture-absorbing properties, pose unique challenges in the realm of pharmaceutical product stability. Stability testing is a crucial component in the lifecycle of drug development, ensuring that a product maintains its integrity, efficacy, and safety throughout…

Solid Dosage form, Tablets

Problems with validating capsule drying equipment for gelatin-free capsules.

March 4, 2025 Admin

Problems with validating capsule drying equipment for gelatin-free capsules. Problems with Validating Capsule Drying Equipment for Gelatin-Free Capsules Introduction: In the ever-evolving world of pharmaceuticals, the demand for gelatin-free capsules has increased significantly. These alternatives, often made from materials like hydroxypropyl methylcellulose (HPMC), offer benefits such as vegetarian suitability and improved stability. However, with innovation…

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

Inadequate systems for detecting capsule discoloration under light exposure.

March 4, 2025 Admin

Inadequate systems for detecting capsule discoloration under light exposure. Inadequate systems for detecting capsule discoloration under light exposure. Introduction: Capsules, both hard and soft gelatin, are one of the most popular solid oral dosage forms in the pharmaceutical industry. However, they are not immune to challenges that can affect their quality and efficacy. One such…

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

Addressing Cross-Contamination Risks in Utility Systems for Multi-Layer Tablets

March 4, 2025 Admin

Addressing Cross-Contamination Risks in Utility Systems for Multi-Layer Tablets Addressing Cross-Contamination Risks in Utility Systems for Multi-Layer Tablets Introduction: In the pharmaceutical industry, the production of multi-layer tablets presents unique challenges, particularly concerning cross-contamination risks. These sophisticated dosage forms are designed to deliver multiple active ingredients or release profiles within a single tablet, enhancing therapeutic…

Solid Dosage form, Tablets

Ensuring Adequacy of Water Flow Uniformity in Purified Water Systems

March 4, 2025 Admin

Ensuring Adequacy of Water Flow Uniformity in Purified Water Systems Ensuring Adequacy of Water Flow Uniformity in Purified Water Systems Introduction: In the pharmaceutical industry, purified water is a critical component used in various production processes, from raw material washing to the final product formulation. Ensuring water flow uniformity in purified water systems is crucial…

Solid Dosage form, Tablets

Managing Failures in Steam Quality Validation for Enteric-Coated Tablet Equipment

March 4, 2025 Admin

Managing Failures in Steam Quality Validation for Enteric-Coated Tablet Equipment Managing Failures in Steam Quality Validation for Enteric-Coated Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the sterility and quality of equipment used in the manufacturing process is critical, especially for enteric-coated tablets. Steam quality validation is a vital component of this quality assurance process….

Solid Dosage form, Tablets

Managing Failures in Weight Variation Testing for Sustained Release Tablets

March 4, 2025 Admin

Managing Failures in Weight Variation Testing for Sustained Release Tablets Managing Failures in Weight Variation Testing for Sustained Release Tablets Introduction: In the pharmaceutical industry, ensuring the consistent quality of sustained release tablets is crucial, as they are designed to release medication over an extended period. Weight variation testing is a critical quality control measure…

Solid Dosage form, Tablets

Managing Over-Spray in Film-Coated Tablet Operations

March 3, 2025 Admin

Managing Over-Spray in Film-Coated Tablet Operations Managing Over-Spray in Film-Coated Tablet Operations Introduction: In the pharmaceutical industry, the coating of tablets is a critical operation that enhances the functionality and aesthetic appeal of the product. Film-coating not only protects the drug substance from environmental factors but also improves patient compliance through better appearance and taste…

Solid Dosage form, Tablets

Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions

March 3, 2025 Admin

Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions Introduction: In the pharmaceutical industry, ensuring the consistency and quality of tablets is paramount. One of the critical quality attributes is tablet weight, which can be significantly affected by environmental conditions, particularly humidity. Weight variations…

Solid Dosage form, Tablets

Troubleshooting Non-Uniform Coating in Irregular Tablet Shapes

March 3, 2025 Admin

Troubleshooting Non-Uniform Coating in Irregular Tablet Shapes Troubleshooting Non-Uniform Coating in Irregular Tablet Shapes Introduction: In the intricate world of pharmaceutical manufacturing, ensuring the uniformity of tablet coatings is paramount, particularly when dealing with irregular tablet shapes. These coatings are not just for aesthetic appeal; they serve critical functions such as protecting the tablet’s core,…

Solid Dosage form, Tablets

Addressing Coating Layer Delamination During Quality Testing

March 3, 2025 Admin

Addressing Coating Layer Delamination During Quality Testing Addressing Coating Layer Delamination During Quality Testing Introduction: Coating layer delamination in tablets is a critical issue in the pharmaceutical industry, impacting both product efficacy and patient safety. The coating on a tablet not only serves an aesthetic function but also plays a crucial role in controlling the…

Solid Dosage form, Tablets