Tag: Regulatory compliance

Poor correlation between in vitro dissolution and stability data.

April 24, 2025 Admin

Poor correlation between in vitro dissolution and stability data. Poor correlation between in vitro dissolution and stability data. Introduction: In the pharmaceutical industry, the correlation between in vitro dissolution and stability data is pivotal for ensuring the efficacy and safety of solid oral dosage forms, particularly capsules. Dissolution testing is a key quality control measure…

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

Challenges in validating sealing equipment for oil-filled capsules.

April 23, 2025 Admin

Challenges in validating sealing equipment for oil-filled capsules. Challenges in validating sealing equipment for oil-filled capsules Introduction: In the pharmaceutical industry, the encapsulation process is critical, particularly when it involves oil-filled capsules. These capsules are essential for delivering hydrophobic compounds and essential oils that do not mix well with water. Ensuring the integrity of these…

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

Poor validation of capsule weight variation for powders with low bulk density.

April 23, 2025 Admin

Poor validation of capsule weight variation for powders with low bulk density. Poor validation of capsule weight variation for powders with low bulk density. Introduction: In the pharmaceutical industry, the formulation and manufacture of capsules are crucial for ensuring patient safety and therapeutic efficacy. Capsules, particularly solid oral dosage forms, remain a popular choice due…

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

Difficulty in validating capsule sealing for high-viscosity formulations.

April 23, 2025 Admin

Difficulty in validating capsule sealing for high-viscosity formulations. Difficulty in Validating Capsule Sealing for High-Viscosity Formulations Introduction: In the pharmaceutical industry, the development and manufacturing of solid oral dosage forms, specifically capsules, play a crucial role in delivering medications effectively to patients. Capsules, particularly those filled with high-viscosity formulations, present unique challenges in sealing validation….

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

Challenges in validating capsule inspection machines for transparent capsules.

April 23, 2025 Admin

Challenges in validating capsule inspection machines for transparent capsules. Challenges in Validating Capsule Inspection Machines for Transparent Capsules Introduction: In the pharmaceutical industry, solid oral dosage forms like capsules are crucial due to their ease of use and precise dosing capabilities. Among these, transparent capsules have gained popularity because they allow consumers and healthcare professionals…

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

Inadequate systems for monitoring capsule printing accuracy.

April 23, 2025 Admin

Inadequate systems for monitoring capsule printing accuracy. Inadequate Systems for Monitoring Capsule Printing Accuracy Introduction: In the pharmaceutical industry, ensuring the accuracy of capsule printing is crucial for maintaining drug safety, efficacy, and compliance with regulatory standards. Capsule printing serves as a vital method for product identification, distinguishing between different medications, and providing necessary information…

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

Difficulty in evaluating the stability of multi-particulate capsules.

April 23, 2025 Admin

Difficulty in evaluating the stability of multi-particulate capsules. Difficulty in evaluating the stability of multi-particulate capsules Introduction: In the pharmaceutical industry, ensuring the stability of drug products is crucial for maintaining their efficacy, safety, and quality over their shelf life. Multi-particulate capsules, which contain numerous small, discrete particles within a single dosage form, offer several…

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

Troubleshooting Poor Adhesion of Desiccants in Tablet Packaging

April 23, 2025 Admin

Troubleshooting Poor Adhesion of Desiccants in Tablet Packaging Troubleshooting Poor Adhesion of Desiccants in Tablet Packaging Introduction: In the pharmaceutical industry, maintaining the stability and integrity of tablet formulations is crucial. Tablets are often sensitive to environmental conditions, particularly moisture, which can compromise their quality and efficacy. To mitigate this, desiccants are employed in tablet…

Solid Dosage form, Tablets

Problems with ensuring consistent cleaning of capsule printing heads.

April 23, 2025 Admin

Problems with ensuring consistent cleaning of capsule printing heads. Problems with Ensuring Consistent Cleaning of Capsule Printing Heads Introduction: In the pharmaceutical industry, capsule printing is a critical process that involves imprinting information, such as dosage details or branding, onto the surface of capsules. Maintaining the cleanliness of capsule printing heads is crucial to ensure…

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

Poor validation of capsule sealing temperature profiles.

April 23, 2025 Admin

Poor validation of capsule sealing temperature profiles. Poor validation of capsule sealing temperature profiles. Introduction: The pharmaceutical industry relies heavily on the precision and quality of its manufacturing processes. One critical aspect of ensuring the integrity and effectiveness of solid oral dosage forms, such as capsules, is the validation of capsule sealing temperature profiles. Proper…

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

Poor validation of temperature sensors in capsule drying ovens.

April 22, 2025 Admin

Poor validation of temperature sensors in capsule drying ovens. Poor validation of temperature sensors in capsule drying ovens. Introduction: Temperature control is a critical aspect of pharmaceutical manufacturing, especially in the drying of capsules. Accurate temperature monitoring ensures the quality and efficacy of both hard and soft gelatin capsules. However, poor validation of temperature sensors…

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

Poor reproducibility in swab recovery studies during cleaning validation.

April 22, 2025 Admin

Poor reproducibility in swab recovery studies during cleaning validation. Poor reproducibility in swab recovery studies during cleaning validation. Introduction: Cleaning validation is a critical component of Good Manufacturing Practices (GMP) in the pharmaceutical industry. It ensures that any equipment used in the production of drug products is adequately cleaned to prevent contamination of subsequent batches….

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