Tag: pharmaceutical quality

Inadequate protocols for evaluating shell-to-fill interaction effects.

April 5, 2025 Admin

Inadequate protocols for evaluating shell-to-fill interaction effects. Inadequate Protocols for Evaluating Shell-to-Fill Interaction Effects in Capsules Introduction: In the pharmaceutical industry, solid oral dosage forms such as capsules are a staple due to their ease of administration and versatility. Capsules, which can be either hard or soft gelatin, serve as a vehicle to deliver active…

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

Challenges in validating cleaning processes for low-dose formulations.

April 4, 2025 Admin

Challenges in validating cleaning processes for low-dose formulations. Challenges in validating cleaning processes for low-dose formulations. Introduction: In the pharmaceutical industry, ensuring that equipment used in the manufacturing of drug products is free from contaminants is crucial. This is especially true for low-dose formulations, where even minimal residuals can affect product safety and efficacy. Cleaning…

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

Problems with validating cleaning procedures for encapsulation equipment.

April 2, 2025 Admin

Problems with validating cleaning procedures for encapsulation equipment. Problems with validating cleaning procedures for encapsulation equipment. Introduction: In the pharmaceutical industry, maintaining the cleanliness of manufacturing equipment is critical to ensuring product quality and patient safety. Encapsulation equipment, used extensively for producing both hard and soft gelatin capsules, poses unique challenges when it comes to…

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

Difficulty in conducting root cause analysis for capsule quality failures.

April 2, 2025 Admin

Difficulty in conducting root cause analysis for capsule quality failures. Difficulty in conducting root cause analysis for capsule quality failures. Introduction: The pharmaceutical industry is tasked with the critical responsibility of ensuring that all medicinal products are safe, effective, and of the highest quality. Capsules, both hard and soft gelatin, are among the most common…

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

Inadequate methods for detecting trace levels of insoluble residues.

April 1, 2025 Admin

Inadequate methods for detecting trace levels of insoluble residues. Inadequate Methods for Detecting Trace Levels of Insoluble Residues Introduction: In the pharmaceutical industry, the integrity and purity of drug products are paramount. Particularly with solid oral dosage forms, such as capsules, ensuring that no insoluble residues remain is critical for both efficacy and patient safety….

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

Ensuring Robustness in Quality Management Systems for Multi-Layer Tablets

March 31, 2025 Admin

Ensuring Robustness in Quality Management Systems for Multi-Layer Tablets Ensuring Robustness in Quality Management Systems for Multi-Layer Tablets Introduction: In the pharmaceutical industry, multi-layer tablets represent a significant advancement in drug delivery systems. They offer distinct advantages such as controlled release profiles, improved patient compliance, and the ability to combine incompatible drugs into a single…

Solid Dosage form, Tablets

Identifying Problems in Potency Testing for Extended Release Tablets

March 31, 2025 Admin

Identifying Problems in Potency Testing for Extended Release Tablets Identifying Problems in Potency Testing for Extended Release Tablets Introduction: Extended release tablets are a cornerstone of modern pharmaceutical therapy, providing patients with the convenience of reduced dosing frequency while maintaining therapeutic efficacy over an extended period. Potency testing of these formulations is critical to ensure…

Solid Dosage form, Tablets

Poor reproducibility in gelatin elasticity data under various storage conditions.

March 31, 2025 Admin

Poor reproducibility in gelatin elasticity data under various storage conditions. Poor reproducibility in gelatin elasticity data under various storage conditions. Introduction: Gelatin capsules, both hard and soft gelatin, are pivotal in the pharmaceutical industry as they offer a stable and effective medium for drug delivery. However, the elasticity of gelatin, a critical factor in capsule…

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

Addressing Non-Uniform Coating Failures in Quality Control Checks

March 29, 2025 Admin

Addressing Non-Uniform Coating Failures in Quality Control Checks Addressing Non-Uniform Coating Failures in Quality Control Checks Introduction: In the pharmaceutical industry, the coating of tablets is a critical step that not only enhances the aesthetic appeal of the product but also plays a pivotal role in controlling the release profile, protecting the drug from environmental…

Solid Dosage form, Tablets

Troubleshooting Weight Variation Test Failures in Film-Coated Tablets

March 28, 2025 Admin

Troubleshooting Weight Variation Test Failures in Film-Coated Tablets Troubleshooting Weight Variation Test Failures in Film-Coated Tablets Introduction: The pharmaceutical industry is tasked with producing high-quality, consistent, and safe medicines. Among the solid dosage forms, film-coated tablets are highly prevalent due to their ease of administration, stability, and patient compliance. Ensuring uniformity in weight is a…

Solid Dosage form, Tablets

Addressing Challenges in Process Validation for Immediate Release Tablets

March 24, 2025 Admin

Addressing Challenges in Process Validation for Immediate Release Tablets Addressing Challenges in Process Validation for Immediate Release Tablets Introduction: Immediate release tablets are a cornerstone in the pharmaceutical industry, known for their rapid disintegration and absorption properties, providing swift therapeutic effects. As the demand for these tablets continues to grow, ensuring their efficacy and safety…

Solid Dosage form, Tablets

Real-Time Monitoring of Granulation Moisture Levels During Wet Granulation

March 23, 2025 Admin

Real-Time Monitoring of Granulation Moisture Levels During Wet Granulation Real-Time Monitoring of Granulation Moisture Levels During Wet Granulation Introduction: In the pharmaceutical industry, the manufacturing of solid dosage forms such as tablets often involves the process of wet granulation. This critical process ensures the homogeneity and compressibility of the drug mixture. One of the most…

Solid Dosage form, Tablets