Tag: FDA guidelines

Addressing Non-Compliance in Process Validation for Hygroscopic Tablets

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Addressing Non-Compliance in Process Validation for Hygroscopic Tablets Addressing Non-Compliance in Process Validation for Hygroscopic Tablets Introduction: In the pharmaceutical industry, the process validation of hygroscopic tablets presents unique challenges. Hygroscopic tablets are those that have a tendency to absorb moisture from their surroundings, which can lead to significant issues in their stability, efficacy, and…

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Solid Dosage form, Tablets

Managing API Degradation in Sugar-Coated Tablets During Stability Studies

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Managing API Degradation in Sugar-Coated Tablets During Stability Studies Managing API Degradation in Sugar-Coated Tablets During Stability Studies Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of a drug product throughout its shelf life is of paramount importance. Sugar-coated tablets, a popular dosage form due to their aesthetic appeal and ease of ingestion,…

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Solid Dosage form, Tablets

Managing Calibration Failures in Spray Gun Settings for Sustained Release Tablets

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Managing Calibration Failures in Spray Gun Settings for Sustained Release Tablets Managing Calibration Failures in Spray Gun Settings for Sustained Release Tablets Introduction: In the pharmaceutical industry, ensuring the precise release profile of sustained release tablets is crucial for therapeutic efficacy and patient safety. One of the key processes in manufacturing these tablets is the…

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Solid Dosage form, Tablets

Ensuring Accuracy in Rinse Sampling for Coating Machine Validation

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Ensuring Accuracy in Rinse Sampling for Coating Machine Validation Ensuring Accuracy in Rinse Sampling for Coating Machine Validation Introduction: In the pharmaceutical industry, ensuring the cleanliness and proper validation of coating machines is crucial for both product quality and regulatory compliance. Rinse sampling is a critical component of the cleaning validation process, particularly for coating…

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Solid Dosage form, Tablets

Addressing Overheating Issues in Heat-Sealing Equipment

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Addressing Overheating Issues in Heat-Sealing Equipment Addressing Overheating Issues in Heat-Sealing Equipment Introduction: Heat-sealing equipment is pivotal in the pharmaceutical sector, particularly in the packaging of solid dosage forms like tablets. These machines ensure the integrity and safety of pharmaceutical products by creating airtight seals that protect against environmental factors. However, overheating can pose significant…

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Solid Dosage form, Tablets

Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets

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Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets Introduction: In the pharmaceutical industry, maintaining the purity and quality of solid dosage forms, particularly enteric tablets, is crucial. Enteric tablets, designed to withstand the acidic environment of the stomach and dissolve in…

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Solid Dosage form, Tablets

Validating Cleaning Procedures for Rotary Tablet Press Machines

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Validating Cleaning Procedures for Rotary Tablet Press Machines Validating Cleaning Procedures for Rotary Tablet Press Machines Introduction: In the fast-evolving pharmaceutical industry, ensuring the cleanliness of equipment is paramount for maintaining product quality and patient safety. Rotary tablet press machines, which are crucial for tablet manufacturing, require rigorous cleaning validation to prevent cross-contamination and ensure…

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Solid Dosage form, Tablets

Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing

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Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing Introduction: In the pharmaceutical industry, the manufacturing of enteric-coated tablets requires stringent environmental controls to ensure product integrity and patient safety. The role of Heating, Ventilation, and Air Conditioning (HVAC) systems in maintaining cleanroom conditions is critical. These systems…

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Solid Dosage form, Tablets

Troubleshooting Non-Adherence of Coating Layers in Multi-Layer Tablets

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Troubleshooting Non-Adherence of Coating Layers in Multi-Layer Tablets Troubleshooting Non-Adherence of Coating Layers in Multi-Layer Tablets Introduction: In the pharmaceutical industry, multi-layer tablets are gaining prominence due to their ability to deliver multiple drugs or achieve controlled release profiles. However, these complex formulations often face challenges, particularly with the adherence of coating layers. Ensuring that…

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Solid Dosage form, Tablets

Preventing Color Fading in Sugar-Coated Tablets During Packaging

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Preventing Color Fading in Sugar-Coated Tablets During Packaging Preventing Color Fading in Sugar-Coated Tablets During Packaging Introduction: Sugar-coated tablets have been a staple in the pharmaceutical industry, providing an effective way to mask the taste of medication while enhancing its aesthetic appeal. However, maintaining the vibrant color of these tablets during packaging and storage is…

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Solid Dosage form, Tablets

Troubleshooting Folding Defects in Patient Information Leaflets

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Troubleshooting Folding Defects in Patient Information Leaflets Troubleshooting Folding Defects in Patient Information Leaflets Introduction: Patient Information Leaflets (PILs) are critical components in pharmaceutical packaging, providing essential information about the medication’s usage, dosage, and potential side effects. However, folding defects in these leaflets can lead to serious implications, including miscommunication of drug information, non-compliance with…

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Solid Dosage form, Tablets

Addressing Cracking in Film Coatings of Extended Release Tablets Under Stress

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Addressing Cracking in Film Coatings of Extended Release Tablets Under Stress Addressing Cracking in Film Coatings of Extended Release Tablets Under Stress Introduction: Film coatings are a critical component in the development of extended-release tablets, playing an essential role in the control of drug release rates, protection of the drug from environmental factors, and improving…

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Solid Dosage form, Tablets