Tag: FDA guidelines

Troubleshooting Brittleness in Coated Tablets During Validation Testing

May 21, 2025 Admin

Troubleshooting Brittleness in Coated Tablets During Validation Testing Troubleshooting Brittleness in Coated Tablets During Validation Testing Introduction: In the pharmaceutical industry, tablets are a common and vital dosage form. They offer precise dosing, ease of administration, and stability. However, the process of coating tablets, which enhances their appearance, taste, and stability, can introduce challenges. One…

Solid Dosage form, Tablets

Evaluating Interaction Between Packaging and Tablets in Stability Testing

May 21, 2025 Admin

Evaluating Interaction Between Packaging and Tablets in Stability Testing Evaluating Interaction Between Packaging and Tablets in Stability Testing Introduction: In the pharmaceutical industry, the stability of a drug product is a critical factor that determines its safety, efficacy, and shelf life. Solid dosage forms, like tablets, are particularly sensitive to environmental factors such as humidity,…

Solid Dosage form, Tablets

Addressing Non-Uniform Granule Size in Fluid Bed Granulators During Validation

May 20, 2025 Admin

Addressing Non-Uniform Granule Size in Fluid Bed Granulators During Validation Addressing Non-Uniform Granule Size in Fluid Bed Granulators During Validation Introduction: In the pharmaceutical industry, maintaining consistent granule size during the fluid bed granulation process is crucial for ensuring the quality and efficacy of solid dosage forms like tablets. Granule size uniformity affects the flow…

Solid Dosage form, Tablets

Addressing Residual Solvent Build-Up in Coating Machines After Cleaning

May 20, 2025 Admin

Addressing Residual Solvent Build-Up in Coating Machines After Cleaning Addressing Residual Solvent Build-Up in Coating Machines After Cleaning Introduction: In the pharmaceutical industry, maintaining the cleanliness of coating machines is crucial for ensuring the quality and safety of tablet production. Residual solvents, which can remain after the cleaning process, pose a significant challenge, potentially affecting…

Solid Dosage form, Tablets

Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets

May 19, 2025 Admin

Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets Introduction: The pharmaceutical industry is committed to ensuring that medications are safe, effective, and of the highest quality. One critical aspect of this commitment is dissolution testing, particularly for enteric-coated tablets. These tablets…

Solid Dosage form, Tablets

Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation

May 19, 2025 Admin

Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation Introduction: The pharmaceutical industry is committed to ensuring the safety and efficacy of its products. One critical component of this commitment is the prevention of cross-contamination, particularly in the manufacturing of solid dosage forms like tablets. Blending…

Solid Dosage form, Tablets

Validating Real-Time Monitoring Systems for Blending Equipment

May 18, 2025 Admin

Validating Real-Time Monitoring Systems for Blending Equipment Validating Real-Time Monitoring Systems for Blending Equipment Introduction: In the pharmaceutical industry, ensuring the consistent quality of solid dosage forms is paramount. One critical step in the manufacturing process is blending, where different ingredients are combined to ensure uniformity. With the advent of real-time monitoring systems, pharmaceutical companies…

Solid Dosage form, Tablets

Ensuring Adequate Moisture Barrier in Sugar-Coated Tablet Packaging

May 18, 2025 Admin

Ensuring Adequate Moisture Barrier in Sugar-Coated Tablet Packaging Ensuring Adequate Moisture Barrier in Sugar-Coated Tablet Packaging Introduction: Sugar-coated tablets have been a mainstay in pharmaceutical formulations for decades. Their aesthetic appeal, taste masking, and ability to protect the active pharmaceutical ingredient (API) are among their numerous advantages. However, the hygroscopic nature of sugar poses a…

Solid Dosage form, Tablets

Troubleshooting Non-Adherence to Visual Inspection Standards During Equipment Validation

May 18, 2025 Admin

Troubleshooting Non-Adherence to Visual Inspection Standards During Equipment Validation Troubleshooting Non-Adherence to Visual Inspection Standards During Equipment Validation Introduction: In the pharmaceutical manufacturing industry, particularly in the production of solid dosage forms like tablets, maintaining rigorous quality control is paramount. One of the key components of quality assurance is adhering to visual inspection standards during…

Solid Dosage form, Tablets

Validating Cleaning Procedures for Fluid Bed Dryers in Multi-Product Facilities

May 18, 2025 Admin

Validating Cleaning Procedures for Fluid Bed Dryers in Multi-Product Facilities Validating Cleaning Procedures for Fluid Bed Dryers in Multi-Product Facilities Introduction: In the pharmaceutical industry, fluid bed dryers are crucial for the production of solid dosage forms such as tablets. These sophisticated pieces of equipment facilitate the drying of granulated materials before tablet compression. In…

Solid Dosage form, Tablets

Addressing Failures in Cleaning Validation for High-Speed Compression Machines

May 16, 2025 Admin

Addressing Failures in Cleaning Validation for High-Speed Compression Machines Addressing Failures in Cleaning Validation for High-Speed Compression Machines Introduction: In the pharmaceutical industry, maintaining stringent cleanliness standards for manufacturing equipment is crucial to ensure product safety and efficacy. High-speed compression machines, integral to tablet production, are no exception. Cleaning validation is a critical process that…

Solid Dosage form, Tablets

Validating Rinse Volume Requirements in Cleaning Validation Protocols

May 15, 2025 Admin

Validating Rinse Volume Requirements in Cleaning Validation Protocols Validating Rinse Volume Requirements in Cleaning Validation Protocols Introduction: In the pharmaceutical industry, ensuring that manufacturing equipment is free from contaminants is paramount to product safety and efficacy. Cleaning validation is a critical component of Good Manufacturing Practice (GMP) to confirm that cleaning processes are effective and…

Solid Dosage form, Tablets