Tag: Regulatory compliance

Challenges in ensuring proper serialization for track-and-trace requirements.

April 16, 2025 Admin

Challenges in ensuring proper serialization for track-and-trace requirements. Challenges in ensuring proper serialization for track-and-trace requirements. Introduction: Serialization in the pharmaceutical industry is a crucial process that involves assigning a unique identifier to each saleable unit of a drug, ensuring traceability throughout the supply chain. This process is essential for preventing counterfeit drugs, enhancing patient…

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

Challenges in testing soft gelatin capsules with high oil content.

April 16, 2025 Admin

Challenges in testing soft gelatin capsules with high oil content. Challenges in testing soft gelatin capsules with high oil content Introduction: Soft gelatin capsules are a popular dosage form in the pharmaceutical industry, offering unique advantages such as improved bioavailability and patient compliance. However, when these capsules contain high oil content, they present significant challenges…

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

Inadequate validation of capsule performance under freezing conditions.

April 16, 2025 Admin

Inadequate validation of capsule performance under freezing conditions. Inadequate validation of capsule performance under freezing conditions Introduction: In the pharmaceutical industry, solid oral dosage forms like capsules are a popular choice due to their convenience, stability, and patient compliance. However, the performance of capsules under various environmental conditions, especially freezing conditions, can be a significant…

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

Inadequate systems for monitoring color uniformity over the stability period.

April 16, 2025 Admin

Inadequate systems for monitoring color uniformity over the stability period. Inadequate systems for monitoring color uniformity over the stability period. Introduction: In the pharmaceutical industry, ensuring the quality and consistency of solid oral dosage forms is paramount. Among the critical aspects of quality control is monitoring the color uniformity of capsules over the stability period….

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

Difficulty in distinguishing capsule defects due to environmental effects.

April 16, 2025 Admin

Difficulty in distinguishing capsule defects due to environmental effects. Difficulty in Distinguishing Capsule Defects Due to Environmental Effects Introduction: Capsules, both hard and soft gelatin, are a prevalent form of solid oral dosage utilized in pharmaceutical products. They offer advantages such as ease of swallowing and the ability to mask unpleasant tastes. However, ensuring their…

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

Challenges in ensuring consistent capsule coating thickness during validation.

April 16, 2025 Admin

Challenges in ensuring consistent capsule coating thickness during validation. Challenges in ensuring consistent capsule coating thickness during validation. Introduction: In the pharmaceutical industry, capsules are a prevalent solid oral dosage form due to their ease of administration and ability to deliver precise dosages. Both hard and soft gelatin capsules can be coated for various reasons…

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

Poor alignment of capsule printing during high-speed operations.

April 15, 2025 Admin

Poor alignment of capsule printing during high-speed operations. Poor alignment of capsule printing during high-speed operations. Introduction: The pharmaceutical industry is heavily reliant on efficient and accurate manufacturing processes, especially when it comes to solid oral dosage forms like capsules. Capsule printing is a critical step, serving as a method of identification, branding, and ensuring…

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

Poor reproducibility in disintegration testing for coated capsules.

April 15, 2025 Admin

Poor reproducibility in disintegration testing for coated capsules. Poor reproducibility in disintegration testing for coated capsules Introduction: In the pharmaceutical industry, disintegration testing is a critical quality control measure that ensures that oral dosage forms, such as capsules, break down within a specified time to release their active ingredients. This is particularly important for coated…

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

Inadequate systems for monitoring the alignment of capsule parts during validation.

April 15, 2025 Admin

Inadequate systems for monitoring the alignment of capsule parts during validation. Inadequate systems for monitoring the alignment of capsule parts during validation. Introduction: In the pharmaceutical industry, the integrity of solid oral dosage forms, such as capsules, is paramount to ensuring the efficacy and safety of medications. Among the critical steps in capsule manufacturing is…

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

Lack of validated protocols for capsule imaging and defect detection.

April 15, 2025 Admin

Lack of validated protocols for capsule imaging and defect detection. Lack of validated protocols for capsule imaging and defect detection. Introduction: In the pharmaceutical industry, ensuring the quality and safety of products is paramount. Among the various dosage forms, capsules—both hard and soft gelatin—hold significant importance due to their widespread use. However, the absence of…

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

Poor reproducibility in API stability data for high-dose capsules.

April 15, 2025 Admin

Poor reproducibility in API stability data for high-dose capsules. Poor reproducibility in API stability data for high-dose capsules Introduction: In the pharmaceutical industry, the stability of active pharmaceutical ingredients (APIs) is crucial for ensuring drug safety and efficacy. For high-dose capsules, achieving consistent and reproducible stability data is particularly challenging. Variability in stability data can…

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

Problems with validating capsule drying trays for uniform heat distribution.

April 15, 2025 Admin

Problems with validating capsule drying trays for uniform heat distribution. Problems with validating capsule drying trays for uniform heat distribution. Introduction: In the pharmaceutical industry, the drying process of capsules is a critical step that directly affects the quality and stability of the final product. Proper drying ensures that moisture content is reduced to a…

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