Tag: FDA guidelines

Problems with detecting improper sealing in high-viscosity formulations.

March 4, 2025 Admin

Problems with detecting improper sealing in high-viscosity formulations. Problems with Detecting Improper Sealing in High-Viscosity Formulations Introduction: In pharmaceutical manufacturing, ensuring the integrity of solid oral dosage forms is paramount. Capsules, both hard and soft gelatin, are popular due to their versatility and patient compliance. However, when dealing with high-viscosity formulations, improper sealing poses significant…

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

Addressing Humidity Control Variability in HVAC Systems for Extended Release Tablets

March 4, 2025 Admin

Addressing Humidity Control Variability in HVAC Systems for Extended Release Tablets Addressing Humidity Control Variability in HVAC Systems for Extended Release Tablets Introduction: In the pharmaceutical industry, the production of extended release tablets requires meticulous environmental control to ensure product efficacy and stability. Humidity control, facilitated by advanced HVAC systems, plays a pivotal role in…

Solid Dosage form, Tablets

Resolving Failures in Stability Testing Due to Packaging Interaction

March 3, 2025 Admin

Resolving Failures in Stability Testing Due to Packaging Interaction Resolving Failures in Stability Testing Due to Packaging Interaction Introduction: In the pharmaceutical industry, stability testing is crucial to ensure that a drug product maintains its intended quality, safety, and efficacy throughout its shelf life. Stability testing evaluates how environmental factors such as temperature, humidity, and…

Solid Dosage form, Tablets

Addressing Failures in Coating Thickness Tests for Multi-Layer Tablets

March 3, 2025 Admin

Addressing Failures in Coating Thickness Tests for Multi-Layer Tablets Addressing Failures in Coating Thickness Tests for Multi-Layer Tablets Introduction: In the pharmaceutical industry, ensuring the quality of multi-layer tablets is paramount. One critical aspect is the coating thickness, which directly impacts the tablet’s dissolution rate, stability, and overall efficacy. Coating failures can lead to significant…

Solid Dosage form, Tablets

Addressing Residual Solvent Build-Up in Coating Machines for Sustained Release Tablets

March 3, 2025 Admin

Addressing Residual Solvent Build-Up in Coating Machines for Sustained Release Tablets Addressing Residual Solvent Build-Up in Coating Machines for Sustained Release Tablets Introduction: In the pharmaceutical industry, producing high-quality sustained release tablets involves meticulous attention to several critical processes, one of which is coating. Coating not only enhances the aesthetic value of the tablets but…

Solid Dosage form, Tablets

Challenges in validating equipment used for delayed-release capsule coating.

March 3, 2025 Admin

Challenges in validating equipment used for delayed-release capsule coating. Challenges in validating equipment used for delayed-release capsule coating. Introduction: In the pharmaceutical industry, delayed-release capsule coating is crucial for ensuring that active ingredients are released at the right time and location within the gastrointestinal tract. This technology enhances therapeutic efficacy, minimizes side effects, and improves…

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

Validating Water Circulation Systems for Fluid Bed Granulators

March 3, 2025 Admin

Validating Water Circulation Systems for Fluid Bed Granulators Validating Water Circulation Systems for Fluid Bed Granulators Introduction: The fluid bed granulator is a critical piece of equipment in pharmaceutical manufacturing, particularly in the production of solid dosage forms like tablets. Central to its operation is the water circulation system, which plays a crucial role in…

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

Ensuring Compliance with Regulatory Standards for Clean Steam Quality

March 3, 2025 Admin

Ensuring Compliance with Regulatory Standards for Clean Steam Quality Ensuring Compliance with Regulatory Standards for Clean Steam Quality Introduction: In the pharmaceutical industry, clean steam is a critical component used in various processes, including sterilization and humidification. Ensuring compliance with regulatory standards for clean steam quality is essential to maintain the safety and efficacy of…

Solid Dosage form, Tablets

Poor reproducibility in validation results for air filtration systems.

March 3, 2025 Admin

Poor reproducibility in validation results for air filtration systems. Poor reproducibility in validation results for air filtration systems. Introduction: In the pharmaceutical industry, air filtration systems are crucial for maintaining cleanroom standards and ensuring the quality and safety of products, especially in the manufacturing of solid oral dosage forms like capsules. These systems are designed…

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

Addressing Cross-Contamination Risks in Shared Utility Lines for Coated Tablets

March 3, 2025 Admin

Addressing Cross-Contamination Risks in Shared Utility Lines for Coated Tablets Addressing Cross-Contamination Risks in Shared Utility Lines for Coated Tablets Introduction: In the pharmaceutical industry, maintaining product integrity and patient safety is paramount. One of the significant challenges faced by manufacturers is the risk of cross-contamination, especially when utilizing shared utility lines for coated tablets….

Solid Dosage form, Tablets

Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production

March 3, 2025 Admin

Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining the safety and efficacy of drug products. High-shear mixers are integral in the production of tablets, especially those containing multiple…

Solid Dosage form, Tablets