Tag: USFDA guidelines

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

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

Troubleshooting Conveyor Speed Variation in Blister Packing Machines

April 22, 2025 Admin

Troubleshooting Conveyor Speed Variation in Blister Packing Machines Troubleshooting Conveyor Speed Variation in Blister Packing Machines Introduction: In the pharmaceutical industry, blister packing machines are vital for efficiently packaging tablets and capsules. However, one of the common challenges faced by manufacturers is conveyor speed variation, which can lead to significant bottlenecks and affect the overall…

Solid Dosage form, Tablets

Difficulty in achieving consistent lubrication of filling equipment.

April 22, 2025 Admin

Difficulty in achieving consistent lubrication of filling equipment. Difficulty in Achieving Consistent Lubrication of Filling Equipment Introduction: In the pharmaceutical industry, maintaining efficient and consistent operations is critical to ensure product quality and regulatory compliance. One of the significant challenges faced by manufacturers of solid oral dosage forms, particularly capsules, is achieving consistent lubrication of…

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

Ensuring Adequate Sealing in Multi-Chamber Blister Packs for Multi-Layer Tablets

April 22, 2025 Admin

Ensuring Adequate Sealing in Multi-Chamber Blister Packs for Multi-Layer Tablets Ensuring Adequate Sealing in Multi-Chamber Blister Packs for Multi-Layer Tablets Introduction: In the ever-evolving pharmaceutical industry, packaging plays a crucial role in ensuring drug efficacy, safety, and compliance. Multi-chamber blister packs are increasingly favored for their ability to segregate multi-layer tablets, offering enhanced protection and…

Solid Dosage form, Tablets

Poor alignment of capsule packs within carton trays.

April 21, 2025 Admin

Poor alignment of capsule packs within carton trays. Poor alignment of capsule packs within carton trays. Introduction: In the pharmaceutical industry, packaging plays a crucial role in maintaining product integrity and ensuring patient safety. Poor alignment of capsule packs within carton trays is a common issue that can lead to inefficiencies and potential product damage….

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

Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing

April 21, 2025 Admin

Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing Introduction: Sugar-coated tablets are a popular dosage form in the pharmaceutical industry, valued for their aesthetic appeal and ability to mask unpleasant tastes. However, these advantages can be overshadowed by challenges encountered during stability testing, particularly disintegration…

Solid Dosage form, Tablets

Difficulty in maintaining consistent capsule appearance during production.

April 21, 2025 Admin

Difficulty in maintaining consistent capsule appearance during production. Difficulty in maintaining consistent capsule appearance during production. Introduction: Capsule appearance is a critical quality attribute in pharmaceutical manufacturing. The appearance not only reflects the aesthetic qualities of the product but also its safety, efficacy, and compliance with regulatory standards. Inconsistent capsule appearance during production can lead…

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

Difficulty in assessing the stability of capsules containing low-dose APIs.

April 21, 2025 Admin

Difficulty in assessing the stability of capsules containing low-dose APIs. Difficulty in assessing the stability of capsules containing low-dose APIs. Introduction: In the pharmaceutical industry, ensuring the stability of drug products is paramount, particularly when dealing with capsules containing low-dose Active Pharmaceutical Ingredients (APIs). Stability refers to the ability of a drug product to maintain…

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

Problems with ensuring proper cleaning of capsule sealing equipment.

April 20, 2025 Admin

Problems with ensuring proper cleaning of capsule sealing equipment. Problems with ensuring proper cleaning of capsule sealing equipment. Introduction: The pharmaceutical industry is synonymous with precision, safety, and quality. Among the various processes, the sealing of capsules—both hard and soft gelatin—holds a pivotal role. Ensuring the cleanliness of capsule sealing equipment is crucial not only…

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

Poor correlation between laboratory and field stability data for capsules.

April 20, 2025 Admin

Poor correlation between laboratory and field stability data for capsules. Poor correlation between laboratory and field stability data for capsules. Introduction: In the pharmaceutical industry, stability testing is a critical component that ensures the safety, efficacy, and quality of drug products throughout their shelf life. Capsules, both hard and soft gelatin, are popular solid oral…

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