Tag: Regulatory Guidelines

Detecting Layer Delamination in Multi-Layer Tablets During Production

March 8, 2025 Admin

Detecting Layer Delamination in Multi-Layer Tablets During Production Detecting Layer Delamination in Multi-Layer Tablets During Production Introduction: In the pharmaceutical industry, multi-layer tablets offer a sophisticated solution to delivering complex drug regimens. These tablets are designed to release active ingredients at different rates or to combine incompatible agents within a single dosage form. However, ensuring…

Solid Dosage form, Tablets

Preventing Printing Errors on Outer Cartons for Bulk Tablet Packaging

March 8, 2025 Admin

Preventing Printing Errors on Outer Cartons for Bulk Tablet Packaging Preventing Printing Errors on Outer Cartons for Bulk Tablet Packaging Introduction: In the pharmaceutical industry, packaging is not just about aesthetics or branding; it is a critical component of ensuring drug safety and efficacy. High-volume tablet packaging requires precision, especially when it comes to printing…

Solid Dosage form, Tablets

Ensuring Consistency in Clean Steam Quality for Fluid Bed Granulators

March 8, 2025 Admin

Ensuring Consistency in Clean Steam Quality for Fluid Bed Granulators Ensuring Consistency in Clean Steam Quality for Fluid Bed Granulators Introduction: In the pharmaceutical industry, the quality of clean steam used in fluid bed granulators is paramount. Clean steam is crucial for maintaining the integrity and efficacy of the final product, as it is directly…

Solid Dosage form, Tablets

Challenges in ensuring proper alignment of capsule packs in cartons.

March 7, 2025 Admin

Challenges in ensuring proper alignment of capsule packs in cartons. Challenges in ensuring proper alignment of capsule packs in cartons. Introduction: Proper alignment of capsule packs in cartons is a critical component in pharmaceutical manufacturing and packaging. This process is crucial to ensure product integrity, safety, and compliance with stringent industry regulations. Ensuring that capsule…

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

Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing

March 7, 2025 Admin

Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing Introduction: Coated tablets are a prevalent form of medication delivery in the pharmaceutical industry, designed to improve the stability, appearance, and release characteristics of the active pharmaceutical ingredient (API). The disintegration of these tablets is a critical quality attribute…

Solid Dosage form, Tablets

Addressing Non-Adherence to Cleanroom Temperature Standards During Validation

March 6, 2025 Admin

Addressing Non-Adherence to Cleanroom Temperature Standards During Validation Addressing Non-Adherence to Cleanroom Temperature Standards During Validation Introduction: The pharmaceutical industry hinges on stringent environmental controls to ensure product safety and efficacy. Among these controls, maintaining the correct temperature in cleanrooms during the validation phase is critical. Cleanrooms are designed to limit the presence of airborne…

Solid Dosage form, Tablets

Inadequate validation protocols for new capsule formulations.

March 4, 2025 Admin

Inadequate validation protocols for new capsule formulations. Inadequate Validation Protocols for New Capsule Formulations Introduction: The pharmaceutical industry is continually evolving, with innovations leading to new and effective drug delivery systems. Among these, capsules remain a popular choice due to their ease of administration and ability to encapsulate a wide range of drug compounds. However,…

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

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

Addressing Failures in Adhesion Tests for Enteric-Coated Tablets

March 3, 2025 Admin

Addressing Failures in Adhesion Tests for Enteric-Coated Tablets Addressing Failures in Adhesion Tests for Enteric-Coated Tablets Introduction: Enteric-coated tablets have revolutionized the pharmaceutical industry by providing a targeted delivery system that ensures the active pharmaceutical ingredient (API) is released in the intestine rather than the stomach. This is crucial for drugs that can be inactivated…

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

Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies

March 3, 2025 Admin

Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies Introduction: In the pharmaceutical industry, ensuring the safety and efficacy of products is paramount. Residual solvent analysis plays a critical role in utility validation studies, which are essential to maintaining the integrity of solid dosage…

Solid Dosage form, Tablets

Managing Failures in Batch Sampling for Quality Assurance

March 2, 2025 Admin

Managing Failures in Batch Sampling for Quality Assurance Managing Failures in Batch Sampling for Quality Assurance Introduction: In the pharmaceutical industry, ensuring the quality of a product is paramount. Batch sampling plays a critical role in this process, providing a snapshot that represents the entire production batch. However, managing failures in batch sampling is crucial…

Solid Dosage form, Tablets