Tag: USFDA guidelines

Ensuring Consistency in Binder Addition During Wet Granulation Validation

April 14, 2025 Admin

Ensuring Consistency in Binder Addition During Wet Granulation Validation Ensuring Consistency in Binder Addition During Wet Granulation Validation Introduction: In the world of pharmaceutical manufacturing, wet granulation remains a cornerstone technique for producing tablets. The process involves the addition of a binder solution to the powder mix to form granules, which are then compressed to…

Solid Dosage form, Tablets

Problems with ensuring consistent performance of dehumidification systems.

April 12, 2025 Admin

Problems with ensuring consistent performance of dehumidification systems. Problems with ensuring consistent performance of dehumidification systems. Introduction: In the manufacturing of solid oral dosage forms, particularly capsules, maintaining the right environmental conditions is crucial. Dehumidification systems play a significant role in ensuring that humidity levels are optimal for processes such as mixing, encapsulation, and storage….

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

Difficulty in evaluating the impact of excipient changes on capsule stability.

April 12, 2025 Admin

Difficulty in evaluating the impact of excipient changes on capsule stability. Difficulty in Evaluating the Impact of Excipient Changes on Capsule Stability Introduction: In the pharmaceutical industry, the stability of a drug product is a critical factor that influences its safety, efficacy, and shelf-life. Capsules, both hard and soft gelatin, are popular solid oral dosage…

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

Addressing Misalignment of Leaflets in Carton Folding Machines

April 12, 2025 Admin

Addressing Misalignment of Leaflets in Carton Folding Machines Addressing Misalignment of Leaflets in Carton Folding Machines Introduction: In the pharmaceutical industry, ensuring precise leaflet placement in carton folding machines is critical for maintaining packaging integrity and compliance. The correct alignment of leaflets not only upholds the aesthetic quality but is also vital for meeting regulatory…

Solid Dosage form, Tablets

Ensuring Uniform Film Thickness in Blister Pack Lids

April 11, 2025 Admin

Ensuring Uniform Film Thickness in Blister Pack Lids Ensuring Uniform Film Thickness in Blister Pack Lids Introduction: In the pharmaceutical industry, blister packaging is a crucial component for ensuring the integrity, safety, and efficacy of solid dosage forms such as tablets. The uniformity of film thickness in blister pack lids is vital as it directly…

Solid Dosage form, Tablets

High rejection rates due to improperly filled capsule packs.

April 11, 2025 Admin

High rejection rates due to improperly filled capsule packs. High Rejection Rates Due to Improperly Filled Capsule Packs Introduction: In the pharmaceutical industry, solid oral dosage forms such as capsules are a cornerstone due to their convenience and efficacy in delivering medication. However, the integrity of capsule packs is paramount to ensure patient safety and…

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

Addressing Impact of Oxidative Stress on Sugar-Coated Tablets

April 11, 2025 Admin

Addressing Impact of Oxidative Stress on Sugar-Coated Tablets Addressing Impact of Oxidative Stress on Sugar-Coated Tablets Introduction: In the pharmaceutical industry, the stability of drug formulations is paramount to ensuring efficacy and safety. Among the various solid dosage forms, sugar-coated tablets offer unique benefits such as taste masking and protection of active ingredients. However, these…

Solid Dosage form, Tablets

Inadequate systems for validating capsule drying profiles for soft gelatin capsules.

April 10, 2025 Admin

Inadequate systems for validating capsule drying profiles for soft gelatin capsules. Inadequate systems for validating capsule drying profiles for soft gelatin capsules. Introduction: Soft gelatin capsules are a popular dosage form in the pharmaceutical industry due to their versatility in encapsulating a wide range of substances, including liquids, suspensions, and semi-solids. Ensuring the proper drying…

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

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

Challenges in detecting improper sealing of capsule containers.

April 10, 2025 Admin

Challenges in detecting improper sealing of capsule containers. Challenges in detecting improper sealing of capsule containers. Introduction: In the pharmaceutical industry, ensuring the integrity of packaging is paramount, especially for solid oral dosage forms like capsules. Proper sealing of capsule containers is crucial not only for maintaining the efficacy and shelf-life of the product but…

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

Addressing Heat Warping of Films in High-Speed Packaging Machines

April 9, 2025 Admin

Addressing Heat Warping of Films in High-Speed Packaging Machines Addressing Heat Warping of Films in High-Speed Packaging Machines Introduction: In the fast-paced world of pharmaceutical manufacturing, efficiency and precision are paramount, especially when it comes to packaging. High-speed packaging machines are crucial for meeting production demands, but they bring unique challenges, particularly with the heat…

Solid Dosage form, Tablets

Poor validation of water storage tanks for microbial control.

April 9, 2025 Admin

Poor validation of water storage tanks for microbial control. Poor validation of water storage tanks for microbial control. Introduction: In pharmaceutical manufacturing, maintaining the integrity of water systems is crucial for ensuring product quality and patient safety. Water storage tanks play a pivotal role in safeguarding the purity and quality of water used throughout the…

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