Tag: USFDA guidelines

Addressing Die Wear Issues in Tablet Press Machines

March 30, 2025 Admin

Addressing Die Wear Issues in Tablet Press Machines Addressing Die Wear Issues in Tablet Press Machines Introduction: In the pharmaceutical industry, the production of tablets is a critical process that demands precision and consistency. Tablet press machines, essential to this process, must operate efficiently to ensure that the tablets produced meet stringent quality standards. One…

Solid Dosage form, Tablets

Inadequate systems for detecting air bubbles in soft gelatin capsules.

March 29, 2025 Admin

Inadequate systems for detecting air bubbles in soft gelatin capsules. Inadequate Systems for Detecting Air Bubbles in Soft Gelatin Capsules Introduction: Soft gelatin capsules are a popular dosage form in the pharmaceutical industry due to their ease of swallowing and ability to encapsulate a wide range of active ingredients. However, ensuring the quality and integrity…

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

Identifying Root Causes of Content Non-Uniformity in Tablets

March 29, 2025 Admin

Identifying Root Causes of Content Non-Uniformity in Tablets Identifying Root Causes of Content Non-Uniformity in Tablets Introduction: Content uniformity in tablets is a critical quality attribute that ensures each tablet contains an equal amount of the active pharmaceutical ingredient (API). This consistency is vital for efficacy, safety, and regulatory compliance. The challenge of maintaining content…

Solid Dosage form, Tablets

Poor control of environmental conditions in packing areas.

March 29, 2025 Admin

Poor control of environmental conditions in packing areas. Poor control of environmental conditions in packing areas. Introduction: The pharmaceutical industry is heavily reliant on maintaining stringent environmental conditions to ensure product quality and safety, especially in the packing areas. Poor control of these conditions can lead to compromised product integrity, impacting patient safety and regulatory…

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

Addressing Poor Adhesion in Film Coatings During Stability Studies

March 29, 2025 Admin

Addressing Poor Adhesion in Film Coatings During Stability Studies Addressing Poor Adhesion in Film Coatings During Stability Studies Introduction: In the realm of pharmaceutical manufacturing, film coatings on tablets are crucial for various reasons, including enhancing tablet stability, controlling drug release, masking unpleasant tastes, and improving aesthetic appeal. However, one of the common challenges faced…

Solid Dosage form, Tablets

Managing Failures in Weight Variation Tests for High-Speed Compression Tablets

March 28, 2025 Admin

Managing Failures in Weight Variation Tests for High-Speed Compression Tablets Managing Failures in Weight Variation Tests for High-Speed Compression Tablets Introduction: In the pharmaceutical industry, ensuring the consistency and quality of tablet formulations is paramount. Weight variation tests are critical quality control measures that ensure each tablet contains the intended amount of active pharmaceutical ingredient…

Solid Dosage form, Tablets

Addressing Over-Drying in Sugar-Coated Tablets During Curing

March 27, 2025 Admin

Addressing Over-Drying in Sugar-Coated Tablets During Curing Addressing Over-Drying in Sugar-Coated Tablets During Curing Introduction: Sugar-coating is an essential phase in the production of tablets, offering not only aesthetic appeal but also protection from environmental factors. However, one of the prevalent challenges during the sugar-coating process is over-drying, which can compromise the integrity and effectiveness…

Solid Dosage form, Tablets

Ensuring Accuracy in Hardness Testing Procedures for Film-Coated Tablets

March 27, 2025 Admin

Ensuring Accuracy in Hardness Testing Procedures for Film-Coated Tablets Ensuring Accuracy in Hardness Testing Procedures for Film-Coated Tablets Introduction: In the ever-evolving world of pharmaceutical manufacturing, ensuring the quality and efficacy of solid dosage forms such as film-coated tablets is paramount. Hardness testing is a critical quality control measure that determines the mechanical integrity and…

Solid Dosage form, Tablets

Managing Over-Sensitivity to Humidity in Hygroscopic Tablets During Production

March 27, 2025 Admin

Managing Over-Sensitivity to Humidity in Hygroscopic Tablets During Production Managing Over-Sensitivity to Humidity in Hygroscopic Tablets During Production Introduction: Hygroscopic tablets are an essential component of the pharmaceutical industry, offering a convenient and effective means of delivering medication to patients. However, their production poses significant challenges due to their sensitivity to humidity. Excess moisture can…

Solid Dosage form, Tablets

Troubleshooting Thickness Testing Failures in Enteric-Coated Tablets

March 26, 2025 Admin

Troubleshooting Thickness Testing Failures in Enteric-Coated Tablets Troubleshooting Thickness Testing Failures in Enteric-Coated Tablets Introduction: Enteric-coated tablets are a critical component in the pharmaceutical industry, designed to deliver active ingredients to the intestines without being degraded by stomach acid. The integrity of this enteric coating is vital, and one key quality parameter is the thickness…

Solid Dosage form, Tablets

High rejection rates due to non-compliance with quality standards.

March 26, 2025 Admin

High rejection rates due to non-compliance with quality standards. High Rejection Rates Due to Non-Compliance with Quality Standards Introduction: In the pharmaceutical industry, maintaining high-quality standards in manufacturing processes is imperative. Solid oral dosage forms, particularly capsules, are prevalent due to their convenience and efficiency. However, the rejection rates of these products can often spike…

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

Managing Solvent Levels in Film-Coating Processes for Consistency

March 26, 2025 Admin

Managing Solvent Levels in Film-Coating Processes for Consistency Managing Solvent Levels in Film-Coating Processes for Consistency Introduction: In the pharmaceutical industry, the film-coating process of tablets is a crucial step that ensures not only the aesthetic appeal but also the stability and controlled release of the active pharmaceutical ingredients (APIs). Managing solvent levels during this…

Solid Dosage form, Tablets