Tag: USFDA guidelines

Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies.

April 9, 2025 Admin

Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies. Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies. Introduction: In the realm of pharmaceuticals, the dissolution testing of capsules is a critical parameter in ensuring the efficacy and safety of drug products. Evaluating capsule dissolution in biorelevant media during…

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

Difficulty in maintaining proper storage conditions for packaging materials.

April 9, 2025 Admin

Difficulty in maintaining proper storage conditions for packaging materials. Difficulty in Maintaining Proper Storage Conditions for Packaging Materials Introduction: In the pharmaceutical industry, maintaining the integrity and efficacy of products is paramount. Packaging materials, particularly for solid oral dosage forms like capsules, play a critical role in protecting the product from environmental factors and ensuring…

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

Challenges in validating equipment for encapsulating semi-solid formulations.

April 8, 2025 Admin

Challenges in validating equipment for encapsulating semi-solid formulations. Challenges in validating equipment for encapsulating semi-solid formulations. Introduction: In the pharmaceutical industry, the encapsulation of semi-solid formulations presents unique challenges that require precise validation to ensure product efficacy and safety. Semi-solid formulations, often used for their controlled release properties and enhanced bioavailability, demand stringent equipment validation…

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

Problems with detecting microscopic cracks in gelatin shells.

April 8, 2025 Admin

Problems with detecting microscopic cracks in gelatin shells. Problems with Detecting Microscopic Cracks in Gelatin Shells Introduction: Gelatin capsules, both hard and soft, are integral to the pharmaceutical industry due to their effectiveness in encapsulating drugs and providing controlled release. However, ensuring the integrity of these capsules is critical, as even microscopic cracks in the…

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

Validating Coating Thickness Consistency Across Batch Sizes

April 8, 2025 Admin

Validating Coating Thickness Consistency Across Batch Sizes Validating Coating Thickness Consistency Across Batch Sizes Introduction: The pharmaceutical industry places significant emphasis on the quality and consistency of solid dosage forms, particularly tablets. Among the various quality attributes, coating thickness is crucial, influencing not just appearance, but also the release profile, stability, and overall efficacy of…

Solid Dosage form, Tablets

Problems with validating capsule filling processes for hygroscopic powders.

April 8, 2025 Admin

Problems with validating capsule filling processes for hygroscopic powders. Problems with Validating Capsule Filling Processes for Hygroscopic Powders Introduction: In the pharmaceutical industry, encapsulation is a critical process that ensures the delivery of precise dosages in a patient-friendly form. Capsules, whether hard or soft gelatin, are popular due to their ease of administration and ability…

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

Managing Shrink Wrapping Challenges for Immediate Release Tablets

April 8, 2025 Admin

Managing Shrink Wrapping Challenges for Immediate Release Tablets Managing Shrink Wrapping Challenges for Immediate Release Tablets Introduction: Shrink wrapping is a crucial packaging technique used widely in the pharmaceutical industry to ensure the stability and integrity of immediate release tablets. This packaging method involves applying a plastic film around a product, which is then heated…

Solid Dosage form, Tablets

Managing Documentation Errors in Cleaning Validation Protocols

April 7, 2025 Admin

Managing Documentation Errors in Cleaning Validation Protocols Managing Documentation Errors in Cleaning Validation Protocols Introduction: In the pharmaceutical industry, the integrity of cleaning validation protocols is paramount. These protocols ensure that manufacturing processes meet stringent hygiene standards, preventing cross-contamination and ensuring product safety and efficacy. However, managing documentation errors within these protocols poses a significant…

Solid Dosage form, Tablets

Poor reproducibility in monitoring powder flow properties during encapsulation.

April 7, 2025 Admin

Poor reproducibility in monitoring powder flow properties during encapsulation. Poor reproducibility in monitoring powder flow properties during encapsulation. Introduction: In the pharmaceutical industry, encapsulation is a critical process for the manufacturing of solid oral dosage forms. The flow properties of powders are essential, as they determine the efficiency and consistency of the encapsulation process. Poor…

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

Difficulty in validating backup utility systems for critical processes.

April 7, 2025 Admin

Difficulty in validating backup utility systems for critical processes. Difficulty in Validating Backup Utility Systems for Critical Processes Introduction: In the pharmaceutical industry, ensuring the reliability and integrity of processes is of paramount importance. Backup utility systems play a crucial role in maintaining continuous operations, especially for critical processes that cannot afford downtime. Validating these…

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

Problems with predicting the stability of capsules containing sensitive APIs.

April 6, 2025 Admin

Problems with predicting the stability of capsules containing sensitive APIs. Problems with Predicting the Stability of Capsules Containing Sensitive APIs Introduction: In the pharmaceutical industry, ensuring the stability of drug products is paramount to maintaining efficacy and safety throughout their shelf life. Capsules, both hard and soft gelatin, are popular dosage forms due to their…

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

Poor reproducibility in fill material viscosity measurements during production.

April 6, 2025 Admin

Poor reproducibility in fill material viscosity measurements during production. Poor reproducibility in fill material viscosity measurements during production. Introduction: In the pharmaceutical industry, the production of capsules, both hard and soft gelatin, is a critical process that demands precision and consistency. One of the essential parameters in this process is the viscosity of the fill…

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