Tag: pharmaceutical regulations

Inadequate methods for validating chilled water systems in capsule production facilities.

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Inadequate methods for validating chilled water systems in capsule production facilities. Inadequate methods for validating chilled water systems in capsule production facilities. Introduction: In the pharmaceutical industry, maintaining precise environmental conditions is crucial, particularly in capsule production facilities where the quality of chilled water systems can directly impact product integrity. Chilled water systems play a…

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

Difficulty in detecting shell cracks during high-speed manufacturing.

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Difficulty in detecting shell cracks during high-speed manufacturing. Difficulty in detecting shell cracks during high-speed manufacturing. Introduction: Capsules, both hard and soft gelatin, are among the most popular solid oral dosage forms in the pharmaceutical industry. Their wide acceptance is due to their versatility in delivering a variety of active pharmaceutical ingredients (APIs). However, the…

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

Detecting Layer Delamination in Multi-Layer Tablets During Production

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Detecting Layer Delamination in Multi-Layer Tablets During Production Detecting Layer Delamination in Multi-Layer Tablets During Production Introduction: In the pharmaceutical industry, multi-layer tablets offer a sophisticated solution to delivering complex drug regimens. These tablets are designed to release active ingredients at different rates or to combine incompatible agents within a single dosage form. However, ensuring…

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Solid Dosage form, Tablets

Real-Time Monitoring of Spray Uniformity in Coating Processes

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Real-Time Monitoring of Spray Uniformity in Coating Processes Real-Time Monitoring of Spray Uniformity in Coating Processes Introduction: In the pharmaceutical industry, the coating process of tablets is a critical step that significantly influences the quality and efficacy of the final product. Ensuring uniformity in spray coating is essential to achieve the desired therapeutic effects, protect…

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Solid Dosage form, Tablets

Difficulty in testing gelatin-free capsules for uniformity.

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Difficulty in testing gelatin-free capsules for uniformity. Difficulty in Testing Gelatin-Free Capsules for Uniformity Introduction: In the evolving landscape of pharmaceutical formulations, gelatin-free capsules have emerged as a significant advancement, especially for those seeking vegetarian or vegan alternatives. These capsules not only cater to dietary preferences but also overcome some of the limitations associated with…

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

Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems

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Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems Introduction: In the pharmaceutical industry, maintaining the purity of compressed air systems is critical for ensuring the safety and efficacy of solid dosage forms such as tablets. Residual solvent control plays a vital role in…

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Solid Dosage form, Tablets

Investigating Poor API Distribution in Content Uniformity Tests

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Investigating Poor API Distribution in Content Uniformity Tests Investigating Poor API Distribution in Content Uniformity Tests Introduction: The pharmaceutical industry is heavily reliant on the precision and consistency of its products. One critical aspect of ensuring drug efficacy and safety is maintaining uniformity in the active pharmaceutical ingredient (API) distribution within solid dosage forms like…

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Solid Dosage form, Tablets

Addressing Non-Adherence to Cleanroom Temperature Standards During Validation

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Addressing Non-Adherence to Cleanroom Temperature Standards During Validation Addressing Non-Adherence to Cleanroom Temperature Standards During Validation Introduction: The pharmaceutical industry hinges on stringent environmental controls to ensure product safety and efficacy. Among these controls, maintaining the correct temperature in cleanrooms during the validation phase is critical. Cleanrooms are designed to limit the presence of airborne…

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Solid Dosage form, Tablets

Ensuring Adequate Desiccant Placement in Tablet Packaging for Stability

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Ensuring Adequate Desiccant Placement in Tablet Packaging for Stability Ensuring Adequate Desiccant Placement in Tablet Packaging for Stability Introduction: In the pharmaceutical industry, maintaining the stability of tablet formulations is paramount to ensure efficacy, safety, and shelf life. Tablets are susceptible to degradation from environmental factors such as humidity and temperature, making the role of…

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Solid Dosage form, Tablets

Ensuring Consistency in Airborne Particle Monitoring for Immediate Release Tablets

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Ensuring Consistency in Airborne Particle Monitoring for Immediate Release Tablets Ensuring Consistency in Airborne Particle Monitoring for Immediate Release Tablets Introduction: In the pharmaceutical industry, the production of immediate release tablets requires stringent control over environmental conditions to ensure product safety and efficacy. One critical aspect of this control is airborne particle monitoring. Airborne particles,…

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Solid Dosage form, Tablets

Ensuring Compliance with GMP Standards in Tablet Production

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Ensuring Compliance with GMP Standards in Tablet Production Ensuring Compliance with GMP Standards in Tablet Production Introduction: Ensuring compliance with Good Manufacturing Practice (GMP) standards is pivotal in the production of tablets, a prevalent solid dosage form in the pharmaceutical industry. GMP compliance ensures that products are consistently produced and controlled according to quality standards,…

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Solid Dosage form, Tablets

Validating Steam Quality for Fluid Bed Granulators in Multi-Product Facilities

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Validating Steam Quality for Fluid Bed Granulators in Multi-Product Facilities Validating Steam Quality for Fluid Bed Granulators in Multi-Product Facilities Introduction: In the complex landscape of pharmaceutical manufacturing, ensuring the highest quality of products is paramount. One critical aspect of this process is the validation of steam quality, particularly in multi-product facilities where fluid bed…

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Solid Dosage form, Tablets