Tag: FDA guidelines

Troubleshooting Adhesion Problems in Enteric-Coating Materials

March 4, 2025 Admin

Troubleshooting Adhesion Problems in Enteric-Coating Materials Troubleshooting Adhesion Problems in Enteric-Coating Materials Introduction: In the pharmaceutical industry, the development of solid dosage forms such as tablets is a critical process, where enteric coating plays a vital role. Enteric coatings are designed to withstand the acidic environment of the stomach while dissolving in the more neutral…

Solid Dosage form, Tablets

Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets

March 4, 2025 Admin

Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets Introduction: In the pharmaceutical industry, maintaining a high standard of cleanliness is crucial, especially during the manufacturing of coated tablets. Cleaning validation ensures that the cleaning methods employed are effective in removing residues,…

Solid Dosage form, Tablets

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation

March 4, 2025 Admin

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Introduction: In the pharmaceutical industry, maintaining high standards of cleanliness and sanitation is paramount. One critical component of this process is the use of purified water for cleaning validation. The flow rate of purified water…

Solid Dosage form, Tablets

Ensuring Uniform Filling of Tablet Bottles in High-Speed Lines

March 4, 2025 Admin

Ensuring Uniform Filling of Tablet Bottles in High-Speed Lines Ensuring Uniform Filling of Tablet Bottles in High-Speed Lines Introduction: In the fast-paced world of pharmaceutical manufacturing, ensuring the uniform filling of tablet bottles is crucial for maintaining product quality and regulatory compliance. High-speed production lines are the backbone of large-scale pharmaceutical operations, enabling companies to…

Solid Dosage form, Tablets

Ensuring Robustness in Thickness Testing for Extended Release Tablets

March 4, 2025 Admin

Ensuring Robustness in Thickness Testing for Extended Release Tablets Ensuring Robustness in Thickness Testing for Extended Release Tablets Introduction: In the pharmaceutical industry, maintaining the robustness and consistency of extended release tablets is paramount for both efficacy and safety. Thickness testing of these tablets plays a crucial role in ensuring their quality and performance. Variability…

Solid Dosage form, Tablets

Challenges in determining capsule degradation rates under UV light exposure.

March 4, 2025 Admin

Challenges in determining capsule degradation rates under UV light exposure. Challenges in determining capsule degradation rates under UV light exposure. Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of medications is paramount. Capsules, both hard and soft gelatin, are popular solid oral dosage forms due to their ease of use and patient compliance….

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

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs

March 4, 2025 Admin

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Introduction: In the pharmaceutical industry, ensuring the cleanliness and safety of manufacturing equipment is crucial, especially when dealing with low-dose Active Pharmaceutical Ingredients (APIs). Granulators, essential in the tablet production process, must undergo…

Solid Dosage form, Tablets

Challenges in implementing robust quality controls for capsule packaging processes.

March 4, 2025 Admin

Challenges in implementing robust quality controls for capsule packaging processes. Challenges in implementing robust quality controls for capsule packaging processes. Introduction: The pharmaceutical industry prioritizes patient safety and product efficacy, making quality control a critical component of the manufacturing process. Capsules, both hard and soft gelatin, are among the most common solid oral dosage forms….

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

Troubleshooting Failures in Compressed Air Distribution for Coated Tablets

March 4, 2025 Admin

Troubleshooting Failures in Compressed Air Distribution for Coated Tablets Troubleshooting Failures in Compressed Air Distribution for Coated Tablets Introduction: In the pharmaceutical industry, the production of coated tablets is a sophisticated process that requires precision and adherence to strict quality standards. Compressed air plays a vital role in various stages of tablet manufacturing, including coating,…

Solid Dosage form, Tablets

Preventing Double Printing on Blister Pack Lids for Multi-Layer Tablets

March 4, 2025 Admin

Preventing Double Printing on Blister Pack Lids for Multi-Layer Tablets Preventing Double Printing on Blister Pack Lids for Multi-Layer Tablets Introduction: In the dynamic world of pharmaceuticals, packaging plays a crucial role in ensuring the safety, efficacy, and integrity of medicinal products. Among various packaging forms, blister packs are highly favored for their ability to…

Solid Dosage form, Tablets

Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets

March 4, 2025 Admin

Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets Introduction: In the pharmaceutical industry, maintaining the integrity of sustained release tablets during production is vital to ensure efficacy and safety. A critical step in this process is validating temperature mapping in cleanrooms, where these tablets are…

Solid Dosage form, Tablets

Problems with validating capsule printing for transparent capsules.

March 4, 2025 Admin

Problems with validating capsule printing for transparent capsules. Problems with validating capsule printing for transparent capsules. Introduction: In the pharmaceutical industry, capsules are a popular solid oral dosage form due to their versatility, ease of administration, and ability to encapsulate a variety of drug formulations. Among the different types of capsules, transparent capsules have gained…

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