Tag: pharmaceutical quality

Ensuring Consistent Moisture Control During Stability Testing of Coated Tablets

March 6, 2025 Admin

Ensuring Consistent Moisture Control During Stability Testing of Coated Tablets Ensuring Consistent Moisture Control During Stability Testing of Coated Tablets Introduction: The pharmaceutical industry is driven by the need for quality and consistency, especially when it comes to drug delivery forms like coated tablets. Stability testing is a critical component in ensuring that these tablets…

Solid Dosage form, Tablets

Ensuring Robustness in Utility Validation Documentation for Regulatory Submissions

March 6, 2025 Admin

Ensuring Robustness in Utility Validation Documentation for Regulatory Submissions Ensuring Robustness in Utility Validation Documentation for Regulatory Submissions Introduction: In the pharmaceutical industry, ensuring robustness in utility validation documentation is crucial for successful regulatory submissions. Utility validation serves as a cornerstone in confirming that all systems and processes consistently produce products meeting predetermined specifications and…

Solid Dosage form, Tablets

Addressing API Migration in Bilayer Tablets During Long-Term Testing

March 6, 2025 Admin

Addressing API Migration in Bilayer Tablets During Long-Term Testing Addressing API Migration in Bilayer Tablets During Long-Term Testing Introduction: Bilayer tablets are an innovative pharmaceutical dosage form designed to deliver two different active pharmaceutical ingredients (APIs) or to control the release of a single API over time. However, the process of ensuring the stability and…

Solid Dosage form, Tablets

Addressing Non-Adherence to Cleanroom Temperature Standards During Validation

March 6, 2025 Admin

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…

Solid Dosage form, Tablets

Troubleshooting Brittleness in Multi-Layer Tablets During Hardness Testing

March 5, 2025 Admin

Troubleshooting Brittleness in Multi-Layer Tablets During Hardness Testing Troubleshooting Brittleness in Multi-Layer Tablets During Hardness Testing Introduction: In the world of pharmaceutical manufacturing, the production of multi-layer tablets is both an art and a science. These tablets are designed to deliver multiple active ingredients, each at different release rates, making them highly effective for patients…

Solid Dosage form, Tablets

Ensuring Adequacy of Process Controls for Granulation Stages

March 5, 2025 Admin

Ensuring Adequacy of Process Controls for Granulation Stages Ensuring Adequacy of Process Controls for Granulation Stages Introduction: Granulation is a critical process in the pharmaceutical industry, playing a pivotal role in the production of solid dosage forms such as tablets. It involves the aggregation of powder particles to form larger granules, which enhance the flow…

Solid Dosage form, Tablets

Managing Failures in Humidity Monitoring Systems for Coating Equipment

March 5, 2025 Admin

Managing Failures in Humidity Monitoring Systems for Coating Equipment Managing Failures in Humidity Monitoring Systems for Coating Equipment Introduction: In the pharmaceutical industry, humidity control is a critical factor in the production of tablets, particularly during the coating process. Humidity levels can significantly affect the quality and efficacy of the final product. Coating equipment must…

Solid Dosage form, Tablets

Ensuring Compliance with GMP Standards in Tablet Production

March 4, 2025 Admin

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,…

Solid Dosage form, Tablets

Optimizing Stability Testing Conditions for Hygroscopic Tablets

March 4, 2025 Admin

Optimizing Stability Testing Conditions for Hygroscopic Tablets Optimizing Stability Testing Conditions for Hygroscopic Tablets Introduction: Hygroscopic tablets, known for their moisture-absorbing properties, pose unique challenges in the realm of pharmaceutical product stability. Stability testing is a crucial component in the lifecycle of drug development, ensuring that a product maintains its integrity, efficacy, and safety throughout…

Solid Dosage form, Tablets

Troubleshooting Adhesion Problems in Enteric-Coating Materials

March 4, 2025 Admin

Troubleshooting Adhesion Problems in Enteric-Coating Materials Troubleshooting Adhesion Problems in Enteric-Coating Materials Introduction: In the pharmaceutical industry, the development of solid dosage forms such as tablets is a critical process, where enteric coating plays a vital role. Enteric coatings are designed to withstand the acidic environment of the stomach while dissolving in the more neutral…

Solid Dosage form, Tablets

Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets

March 4, 2025 Admin

Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets Introduction: In the pharmaceutical industry, maintaining a high standard of cleanliness is crucial, especially during the manufacturing of coated tablets. Cleaning validation ensures that the cleaning methods employed are effective in removing residues,…

Solid Dosage form, Tablets

Inadequate systems for detecting capsule discoloration under light exposure.

March 4, 2025 Admin

Inadequate systems for detecting capsule discoloration under light exposure. Inadequate systems for detecting capsule discoloration under light exposure. Introduction: Capsules, both hard and soft gelatin, are one of the most popular solid oral dosage forms in the pharmaceutical industry. However, they are not immune to challenges that can affect their quality and efficacy. One such…

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