Tag: FDA guidelines

Validating Real-Time Moisture Monitoring Systems for Wet Granulation

May 14, 2025 Admin

Validating Real-Time Moisture Monitoring Systems for Wet Granulation Validating Real-Time Moisture Monitoring Systems for Wet Granulation Introduction: Wet granulation is a crucial process in the pharmaceutical industry, particularly for the production of tablets. It involves the agglomeration of powder particles using a liquid binder, resulting in enhanced flowability and compressibility. A critical parameter in this…

Solid Dosage form, Tablets

Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets

May 12, 2025 Admin

Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets Introduction: Enteric-coated tablets are a critical part of modern pharmacology, designed to protect active ingredients from the acidic environment of the stomach and ensure release in the more neutral pH of the intestine. This targeted delivery system…

Solid Dosage form, Tablets

Validating Cleaning Protocols for Sugar-Coating Pans

May 12, 2025 Admin

Validating Cleaning Protocols for Sugar-Coating Pans Validating Cleaning Protocols for Sugar-Coating Pans Introduction: In the pharmaceutical industry, the integrity of solid dosage forms, such as tablets, is paramount. A critical aspect of this process is ensuring that the equipment used, particularly sugar-coating pans, is thoroughly cleaned between batches. This not only prevents cross-contamination but also…

Solid Dosage form, Tablets

Developing Validation Protocols for Tablet Compression Processes

May 10, 2025 Admin

Developing Validation Protocols for Tablet Compression Processes Developing Validation Protocols for Tablet Compression Processes Introduction: The pharmaceutical industry is tasked with ensuring that medications are both safe and effective for consumer use. Part of this responsibility involves the validation of various processes, including the tablet compression process—a critical step in the manufacturing of solid dosage…

Solid Dosage form, Tablets

Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation

May 10, 2025 Admin

Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation Introduction: In the pharmaceutical industry, multi-layer tablets are gaining prominence due to their ability to deliver multiple drugs or release profiles within a single dosage form. This complexity brings forth challenges, particularly in ensuring consistency…

Solid Dosage form, Tablets

Managing Deviations in Batch Records for Enteric-Coated Tablets

May 9, 2025 Admin

Managing Deviations in Batch Records for Enteric-Coated Tablets Managing Deviations in Batch Records for Enteric-Coated Tablets Introduction: In the pharmaceutical industry, maintaining the integrity of batch records is crucial for ensuring the quality and compliance of drug products. Enteric-coated tablets, designed to withstand the acidic environment of the stomach and dissolve in the more neutral…

Solid Dosage form, Tablets

Validating Rinse Water Analysis for Cleaning Validation in Sugar-Coating Processes

May 9, 2025 Admin

Validating Rinse Water Analysis for Cleaning Validation in Sugar-Coating Processes Validating Rinse Water Analysis for Cleaning Validation in Sugar-Coating Processes Introduction: In the pharmaceutical industry, maintaining stringent cleanliness standards is paramount, particularly in processes involving solid dosage forms like tablets. Sugar-coating, a prevalent method for enhancing tablet aesthetics and masking unpleasant tastes, involves multiple stages…

Solid Dosage form, Tablets

Troubleshooting Residual Detergent Issues in Cleaning Validation for Rotary Coating Pans

May 9, 2025 Admin

Troubleshooting Residual Detergent Issues in Cleaning Validation for Rotary Coating Pans Troubleshooting Residual Detergent Issues in Cleaning Validation for Rotary Coating Pans Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining product quality and patient safety. Rotary coating pans, essential in the production of coated tablets, must be meticulously…

Solid Dosage form, Tablets

Managing Documentation Deviations in Process Validation Protocols

May 7, 2025 Admin

Managing Documentation Deviations in Process Validation Protocols Managing Documentation Deviations in Process Validation Protocols Introduction: In the pharmaceutical industry, process validation is a critical component of ensuring product quality and compliance with regulatory standards. It involves a series of documented procedures and protocols designed to confirm that a manufacturing process consistently produces a product meeting…

Solid Dosage form, Tablets

Managing Over-Spray in Sugar-Coating Processes During Validation Runs

May 6, 2025 Admin

Managing Over-Spray in Sugar-Coating Processes During Validation Runs Managing Over-Spray in Sugar-Coating Processes During Validation Runs Introduction: In the pharmaceutical industry, sugar-coating is a critical process for tablet production. It enhances the aesthetic appeal, masks unpleasant tastes, and provides a protective layer to the active pharmaceutical ingredients (APIs). However, managing over-spray during sugar-coating can present…

Solid Dosage form, Tablets

Troubleshooting Failures in Layer Adhesion During Bilayer Tablet Equipment Validation

May 6, 2025 Admin

Troubleshooting Failures in Layer Adhesion During Bilayer Tablet Equipment Validation Troubleshooting Failures in Layer Adhesion During Bilayer Tablet Equipment Validation Introduction: Bilayer tablets have emerged as a significant advancement in pharmaceutical dosage forms, offering the potential for controlled release, improved patient compliance, and enhanced therapeutic efficacy. However, their manufacturing presents unique challenges, particularly concerning layer…

Solid Dosage form, Tablets

Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment

May 5, 2025 Admin

Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment Introduction: In the pharmaceutical industry, ensuring the safety and efficacy of drug products is paramount. With the increasing demand for diverse medications, many manufacturers utilize shared equipment for tablet production to optimize resources. However, shared equipment can pose significant…

Solid Dosage form, Tablets