Tag: Regulatory compliance

Investigating Impact of Oxidative Stress on Coated Tablet Stability

April 25, 2025 Admin

Investigating Impact of Oxidative Stress on Coated Tablet Stability Investigating Impact of Oxidative Stress on Coated Tablet Stability Introduction: In the pharmaceutical industry, the stability of coated tablets is a critical factor in ensuring drug efficacy and safety over their shelf life. Coated tablets are designed to protect the active pharmaceutical ingredients (APIs) from environmental…

Solid Dosage form, Tablets

Inadequate systems for monitoring capsule storage equipment performance.

April 25, 2025 Admin

Inadequate systems for monitoring capsule storage equipment performance. Inadequate systems for monitoring capsule storage equipment performance. Introduction: In the pharmaceutical industry, maintaining the integrity and efficacy of solid oral dosage forms, such as capsules, is paramount. Proper storage is essential to ensure that these products remain safe and effective until they reach the end-user. However,…

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

Resolving Tablet Displacement in Blister Cavities During Packaging

April 25, 2025 Admin

Resolving Tablet Displacement in Blister Cavities During Packaging Resolving Tablet Displacement in Blister Cavities During Packaging Introduction: In the pharmaceutical industry, the packaging of solid dosage forms like tablets is a critical process that ensures product integrity, stability, and patient safety. Blister packaging is one of the most common methods used to protect tablets from…

Solid Dosage form, Tablets

Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations.

April 25, 2025 Admin

Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations. Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations. Introduction: In the pharmaceutical industry, ensuring the cleaning effectiveness of manufacturing equipment is critical, especially when producing gelatin-free formulations. Such formulations represent a growing trend due to dietary preferences, allergies, and religious beliefs. However, the absence of…

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

High variability in capsule weight due to poor powder flow properties.

April 25, 2025 Admin

High variability in capsule weight due to poor powder flow properties. High variability in capsule weight due to poor powder flow properties. Introduction: The pharmaceutical industry consistently strives to achieve high standards of quality and efficacy in its products. Solid oral dosage forms, such as capsules, play a critical role in this landscape. However, one…

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

Challenges in validating nitrogen purity levels for capsule drying processes.

April 25, 2025 Admin

Challenges in validating nitrogen purity levels for capsule drying processes. Challenges in Validating Nitrogen Purity Levels for Capsule Drying Processes Introduction: In the pharmaceutical industry, maintaining the quality and integrity of solid oral dosage forms, such as capsules, is paramount. The drying process of capsules, whether hard or soft gelatin, is a critical step that…

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

Inadequate systems for validating capsule appearance inspection processes.

April 24, 2025 Admin

Inadequate systems for validating capsule appearance inspection processes. Inadequate systems for validating capsule appearance inspection processes. Introduction: The pharmaceutical industry is marked by stringent quality requirements, particularly when it comes to solid oral dosage forms like capsules. A critical aspect of manufacturing is ensuring the appearance of capsules meets predefined standards, as this directly impacts…

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

Troubleshooting Heat Sensitivity of Packaging Films During Sealing

April 24, 2025 Admin

Troubleshooting Heat Sensitivity of Packaging Films During Sealing Troubleshooting Heat Sensitivity of Packaging Films During Sealing Introduction: In the dynamic world of pharmaceutical manufacturing, packaging plays a vital role in ensuring product integrity and efficacy. Among the various facets of packaging, heat sealing of films is critical, especially in maintaining the sterility and stability of…

Solid Dosage form, Tablets

Poor reproducibility in dissolution profiles for lipid-based capsules.

April 24, 2025 Admin

Poor reproducibility in dissolution profiles for lipid-based capsules. Poor reproducibility in dissolution profiles for lipid-based capsules. Introduction: Lipid-based capsules, encompassing both hard and soft gelatin varieties, are critical in the delivery of poorly water-soluble drugs. These formulations improve bioavailability, allowing for efficient drug release and absorption. However, achieving consistent dissolution profiles in lipid-based capsules poses…

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

Difficulty in ensuring compliance with capsule-specific pharmacopeial standards.

April 24, 2025 Admin

Difficulty in ensuring compliance with capsule-specific pharmacopeial standards. Difficulty in ensuring compliance with capsule-specific pharmacopeial standards. Introduction: In the pharmaceutical industry, ensuring compliance with pharmacopeial standards is crucial for the safety and efficacy of drug products. Capsules, both hard and soft gelatin varieties, are a popular dosage form due to their convenience and ability to…

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

Addressing Over-Drying Issues in Granulation During Validation Runs

April 24, 2025 Admin

Addressing Over-Drying Issues in Granulation During Validation Runs Addressing Over-Drying Issues in Granulation During Validation Runs Introduction: In the pharmaceutical industry, granulation is a critical step in the production of solid dosage forms such as tablets. It involves the agglomeration of powder particles to form granules, which enhance the flowability and compressibility of the powder,…

Solid Dosage form, Tablets

Poor validation of capsule integrity under stressed storage conditions.

April 24, 2025 Admin

Poor validation of capsule integrity under stressed storage conditions. Poor validation of capsule integrity under stressed storage conditions. Introduction: In the pharmaceutical industry, the integrity of capsules, whether hard or soft gelatin, is paramount to ensure their efficacy, safety, and quality. Capsules are a popular solid oral dosage form due to their ease of use…

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