Tag: USFDA

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

Managing Calibration Failures in Dissolution Testing Equipment for Coated Tablets

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Managing Calibration Failures in Dissolution Testing Equipment for Coated Tablets Managing Calibration Failures in Dissolution Testing Equipment for Coated Tablets Introduction: Dissolution testing is a critical quality control measure in the pharmaceutical industry, especially for coated tablets. It ensures that the drug releases its active ingredients at the intended rate and extent. However, calibration failures…

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Solid Dosage form, Tablets

Troubleshooting Failures in Rinse Sampling for Fluid Bed Dryers During Validation

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Troubleshooting Failures in Rinse Sampling for Fluid Bed Dryers During Validation Troubleshooting Failures in Rinse Sampling for Fluid Bed Dryers During Validation Introduction: Rinse sampling is a critical step in the validation of fluid bed dryers within pharmaceutical manufacturing. Ensuring that no residues of active pharmaceutical ingredients (APIs) or cleaning agents remain is essential for…

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Solid Dosage form, Tablets

Evaluating Long-Term Stability of Coating Polymers in Enteric Tablets

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Evaluating Long-Term Stability of Coating Polymers in Enteric Tablets Evaluating Long-Term Stability of Coating Polymers in Enteric Tablets Introduction: In the ever-evolving pharmaceutical landscape, ensuring the efficacy and safety of drug delivery systems is paramount. Enteric tablets, designed to withstand the acidic environment of the stomach and release active ingredients in the intestine, rely heavily…

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Solid Dosage form, Tablets

Managing Surface Erosion in Sugar-Coated Tablets During Stability Studies

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Managing Surface Erosion in Sugar-Coated Tablets During Stability Studies Managing Surface Erosion in Sugar-Coated Tablets During Stability Studies Introduction: In the pharmaceutical industry, sugar-coated tablets have been a popular choice for delivering active pharmaceutical ingredients (APIs) due to their aesthetic appeal, ease of swallowing, and ability to mask the taste of certain drugs. However, during…

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Solid Dosage form, Tablets

Troubleshooting Film Tearing in Heat-Sealed Pouches for Sugar-Coated Tablets

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Troubleshooting Film Tearing in Heat-Sealed Pouches for Sugar-Coated Tablets Troubleshooting Film Tearing in Heat-Sealed Pouches for Sugar-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the integrity of packaging is crucial for maintaining the quality and efficacy of drug products. Sugar-coated tablets, known for their aesthetic appeal and taste masking properties, require specific handling and packaging…

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Solid Dosage form, Tablets

Ensuring Robustness in Weight Variation Control During Compression Validation

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Ensuring Robustness in Weight Variation Control During Compression Validation Ensuring Robustness in Weight Variation Control During Compression Validation Introduction: In the pharmaceutical industry, ensuring the uniformity and consistency of tablet production is crucial. Weight variation in tablets can lead to significant quality issues, impacting both efficacy and safety. This makes weight variation control a critical…

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Solid Dosage form, Tablets

Challenges in predicting the impact of high humidity on capsule disintegration times.

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Challenges in predicting the impact of high humidity on capsule disintegration times. Challenges in predicting the impact of high humidity on capsule disintegration times. Introduction: In the realm of pharmaceutical manufacturing, ensuring the efficacy and stability of solid oral dosage forms such as capsules is paramount. Capsules, both hard and soft gelatin, are a prevalent…

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

Addressing Deviations in Stability Studies for Bilayer Tablets

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Addressing Deviations in Stability Studies for Bilayer Tablets Addressing Deviations in Stability Studies for Bilayer Tablets Introduction: Bilayer tablets have emerged as a versatile drug delivery system, offering the advantage of combining two different drugs or formulations with varied release profiles in a single dosage form. This innovation not only improves patient compliance but also…

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Solid Dosage form, Tablets

Difficulty in preventing dust contamination during the packing process.

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Difficulty in preventing dust contamination during the packing process. Difficulty in Preventing Dust Contamination During the Packing Process Introduction: In the realm of pharmaceutical manufacturing, ensuring the integrity and safety of products is paramount. This is especially true in the case of solid oral dosage forms such as capsules. Among the numerous challenges faced in…

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

Difficulty in detecting residual APIs on capsule filling equipment.

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Difficulty in detecting residual APIs on capsule filling equipment. Difficulty in Detecting Residual APIs on Capsule Filling Equipment Introduction: The pharmaceutical industry is committed to ensuring the highest standards of quality and safety. One critical aspect of this is the effective cleaning of capsule filling equipment to prevent cross-contamination and ensure product purity. Residual Active…

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

Problems with ensuring compliance with regulatory guidelines for capsule packaging.

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Problems with ensuring compliance with regulatory guidelines for capsule packaging. Problems with Ensuring Compliance with Regulatory Guidelines for Capsule Packaging Introduction: In the pharmaceutical industry, the packaging of solid oral dosage forms such as capsules plays a critical role in ensuring product safety, efficacy, and quality. Compliance with regulatory guidelines for capsule packaging is essential…

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