Tag: Drug Safety

Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets

March 14, 2025 Admin

Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is crucial, especially when producing film-coated tablets. Cleaning validation, particularly rinse sampling procedures, plays a pivotal role in confirming that any residues from previous…

Solid Dosage form, Tablets

Problems with ensuring compliance with pharmacovigilance requirements.

March 12, 2025 Admin

Problems with ensuring compliance with pharmacovigilance requirements. Problems with ensuring compliance with pharmacovigilance requirements. Introduction: Pharmacovigilance plays a critical role in the pharmaceutical industry, ensuring the safety and efficacy of drugs throughout their lifecycle. Compliance with pharmacovigilance requirements is essential for maintaining drug safety, protecting patient health, and fulfilling regulatory obligations. However, achieving and maintaining…

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

Inadequate systems for monitoring capsule integrity during production.

March 11, 2025 Admin

Inadequate systems for monitoring capsule integrity during production. Inadequate systems for monitoring capsule integrity during production. Introduction: The pharmaceutical industry continuously strives to ensure the highest quality of its products, and capsule integrity plays a crucial role in this process. Capsules, whether hard or soft gelatin, are a popular solid oral dosage form, valued for…

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

Troubleshooting Residual Solvent Issues in Utility Lines for Sugar-Coated Tablets

March 10, 2025 Admin

Troubleshooting Residual Solvent Issues in Utility Lines for Sugar-Coated Tablets Troubleshooting Residual Solvent Issues in Utility Lines for Sugar-Coated Tablets Introduction: In the pharmaceutical manufacturing landscape, sugar-coated tablets are a popular dosage form due to their aesthetic appeal and ease of swallowing. However, the manufacturing process involves various challenges, especially when it comes to managing…

Solid Dosage form, Tablets

Addressing Coating Peel-Off During Stability Studies

March 8, 2025 Admin

Addressing Coating Peel-Off During Stability Studies Addressing Coating Peel-Off During Stability Studies Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability and integrity of tablet coatings is paramount. Coatings play a crucial role in protecting the active pharmaceutical ingredient (API), controlling release profiles, improving patient compliance, and enhancing the aesthetic appeal of the product….

Solid Dosage form, Tablets

Difficulty in testing for capsule tamper resistance.

March 7, 2025 Admin

Difficulty in testing for capsule tamper resistance. Difficulty in Testing for Capsule Tamper Resistance Introduction: In the pharmaceutical industry, ensuring the integrity and safety of drug products is paramount. Capsules, both hard and soft gelatin, are popular solid oral dosage forms due to their convenience and efficiency in delivering medication. However, they are vulnerable to…

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

Ensuring Robustness in Disintegration Tests for High-Dose Tablets

March 5, 2025 Admin

Ensuring Robustness in Disintegration Tests for High-Dose Tablets Ensuring Robustness in Disintegration Tests for High-Dose Tablets Introduction: In the pharmaceutical industry, high-dose tablets serve as a critical vehicle for delivering therapeutic agents effectively. Disintegration tests are essential for ensuring that these tablets dissolve appropriately, releasing their active ingredients for absorption. For high-dose tablets, achieving reliable…

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

Problems with validating capsule printing for transparent capsules.

March 4, 2025 Admin

Problems with validating capsule printing for transparent capsules. Problems with validating capsule printing for transparent capsules. Introduction: In the pharmaceutical industry, capsules are a popular solid oral dosage form due to their versatility, ease of administration, and ability to encapsulate a variety of drug formulations. Among the different types of capsules, transparent capsules have gained…

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

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets

March 4, 2025 Admin

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Introduction: In the pharmaceutical industry, the production of multi-layer tablets requires meticulous attention to detail to ensure product safety and efficacy. One critical aspect of tablet production is the use of fluid bed granulators, which…

Solid Dosage form, Tablets

Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production

March 3, 2025 Admin

Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining the safety and efficacy of drug products. High-shear mixers are integral in the production of tablets, especially those containing multiple…

Solid Dosage form, Tablets

Validating Residual Solvent Control Measures in Coated Tablets

March 2, 2025 Admin

Validating Residual Solvent Control Measures in Coated Tablets Validating Residual Solvent Control Measures in Coated Tablets Introduction: Residual solvents are volatile chemicals used or produced in the manufacture of pharmaceutical substances, excipients, or in the preparation of drug products. Their presence in pharmaceuticals is a critical quality and safety concern, especially in coated tablets where…

Solid Dosage form, Tablets