Tag: pharmaceutical best practices

Poor reproducibility in weight variation measurements over extended storage.

April 13, 2025 Admin

Poor reproducibility in weight variation measurements over extended storage. Poor reproducibility in weight variation measurements over extended storage. Introduction: In the pharmaceutical industry, ensuring the consistency and quality of solid oral dosage forms is paramount. Capsules, both hard and soft gelatin, are popular due to their ease of administration and versatility. However, maintaining their weight…

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

High rejection rates due to shell deformation during drying.

April 12, 2025 Admin

High rejection rates due to shell deformation during drying. High rejection rates due to shell deformation during drying. Introduction: Within the realm of pharmaceutical manufacturing, solid oral dosage forms such as capsules remain a staple due to their convenience and efficacy in drug delivery. However, one of the recurring challenges in the production of both…

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

Poor validation of capsule disintegration profiles for capsules stored under stressed conditions.

April 11, 2025 Admin

Poor validation of capsule disintegration profiles for capsules stored under stressed conditions. Poor validation of capsule disintegration profiles for capsules stored under stressed conditions. Introduction: In the pharmaceutical industry, ensuring the effective disintegration of capsules is crucial for the drug’s efficacy and safety. Disintegration testing is an essential quality control measure that determines whether capsules…

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

Inadequate systems for verifying capsule alignment in high-speed operations.

April 11, 2025 Admin

Inadequate systems for verifying capsule alignment in high-speed operations. Inadequate Systems for Verifying Capsule Alignment in High-Speed Operations Introduction: In the pharmaceutical manufacturing industry, ensuring the proper alignment of capsules in high-speed operations is crucial for maintaining product quality and compliance with regulatory standards. Misalignment can lead to significant production inefficiencies, increased waste, and potential…

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

Ensuring Consistency in Hardness Testing Across Tablet Batches

April 10, 2025 Admin

Ensuring Consistency in Hardness Testing Across Tablet Batches Ensuring Consistency in Hardness Testing Across Tablet Batches Introduction: In the pharmaceutical industry, ensuring the consistency and quality of tablet batches is paramount. Among the various quality attributes, hardness is a critical parameter that significantly impacts the tablet’s integrity, disintegration, and dissolution profiles. Inconsistencies in hardness can…

Solid Dosage form, Tablets

Ensuring Batch-to-Batch Consistency in Weight Variation Validation

April 10, 2025 Admin

Ensuring Batch-to-Batch Consistency in Weight Variation Validation Ensuring Batch-to-Batch Consistency in Weight Variation Validation Introduction: In the pharmaceutical industry, ensuring the consistency and quality of tablet production is paramount. Weight variation validation is a critical component in the manufacturing process of solid dosage forms, particularly tablets. It ensures that each tablet in a batch contains…

Solid Dosage form, Tablets

Addressing Core Erosion in Sugar-Coated Tablets During Validation Runs

April 8, 2025 Admin

Addressing Core Erosion in Sugar-Coated Tablets During Validation Runs Addressing Core Erosion in Sugar-Coated Tablets During Validation Runs Introduction: Sugar-coated tablets have been a staple in the pharmaceutical industry, offering a palatable and aesthetically pleasing way to deliver medications. However, the process of sugar coating can present unique challenges, particularly during validation runs, a critical…

Solid Dosage form, Tablets

Poor reproducibility in monitoring capsule weight variation.

April 8, 2025 Admin

Poor reproducibility in monitoring capsule weight variation. Poor reproducibility in monitoring capsule weight variation. Introduction: Capsules, as solid oral dosage forms, play a critical role in the pharmaceutical industry due to their ease of administration, stability, and ability to encapsulate a variety of substances. However, ensuring consistent weight and content uniformity remains a significant challenge,…

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

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

Difficulty in ensuring consistent shell color during production.

April 6, 2025 Admin

Difficulty in ensuring consistent shell color during production. Difficulty in ensuring consistent shell color during production. Introduction: In the pharmaceutical industry, the appearance of dosage forms such as capsules plays a vital role in product quality and consumer trust. Consistent shell color is critical, not only for aesthetic appeal but also for branding and patient…

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

Inadequate systems for reviewing and updating quality-related documents.

April 5, 2025 Admin

Inadequate systems for reviewing and updating quality-related documents. Inadequate Systems for Reviewing and Updating Quality-Related Documents Introduction: In the pharmaceutical industry, maintaining up-to-date and accurate quality-related documents is crucial. These documents ensure compliance with regulatory standards, facilitate efficient operations, and uphold product quality and safety. Despite their significance, many organizations struggle with inadequate systems for…

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