Tag: FDA guidelines

Challenges in validating capsule sealing for capsules with modified-release coatings.

March 2, 2025 Admin

Challenges in validating capsule sealing for capsules with modified-release coatings. Challenges in validating capsule sealing for capsules with modified-release coatings Introduction: In the pharmaceutical industry, capsules remain a popular dosage form due to their versatility and patient compliance. Specifically, capsules with modified-release coatings offer the advantage of controlled drug release, enhancing therapeutic efficacy and minimizing…

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

Validating Residual Solvent Control Measures in Coated Tablets

March 2, 2025 Admin

Validating Residual Solvent Control Measures in Coated Tablets Validating Residual Solvent Control Measures in Coated Tablets Introduction: Residual solvents are volatile chemicals used or produced in the manufacture of pharmaceutical substances, excipients, or in the preparation of drug products. Their presence in pharmaceuticals is a critical quality and safety concern, especially in coated tablets where…

Solid Dosage form, Tablets

Inadequate systems for monitoring microbial control in water systems.

March 2, 2025 Admin

Inadequate systems for monitoring microbial control in water systems. Inadequate systems for monitoring microbial control in water systems. Introduction: In the pharmaceutical industry, water is a critical component used in various stages of drug manufacturing, from formulation to cleaning processes. Ensuring the microbiological quality of water is paramount, as inadequate systems for monitoring microbial control…

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

Validating Agglomeration Control Measures in Fluid Bed Granulation Processes

March 2, 2025 Admin

Validating Agglomeration Control Measures in Fluid Bed Granulation Processes Validating Agglomeration Control Measures in Fluid Bed Granulation Processes Introduction: In the pharmaceutical industry, the production of solid dosage forms such as tablets relies heavily on fluid bed granulation processes. This technique is essential for enhancing the flowability and compressibility of powders, which directly impacts the…

Solid Dosage form, Tablets

Addressing Coating Delamination Issues During In-Process Quality Checks

March 2, 2025 Admin

Addressing Coating Delamination Issues During In-Process Quality Checks Addressing Coating Delamination Issues During In-Process Quality Checks Introduction: In the pharmaceutical industry, tablets are one of the most common solid dosage forms. The coating of these tablets plays a pivotal role not only in aesthetics but also in functionality, including protection from environmental conditions, masking taste,…

Solid Dosage form, Tablets

Managing Cleaning Validation Failures for Immediate Release Tablet Equipment

March 2, 2025 Admin

Managing Cleaning Validation Failures for Immediate Release Tablet Equipment Managing Cleaning Validation Failures for Immediate Release Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical to product quality and safety. Particularly for immediate release tablets, stringent cleaning protocols prevent cross-contamination and guarantee that residue levels remain within acceptable limits….

Solid Dosage form, Tablets

Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets

March 2, 2025 Admin

Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets Introduction: In the pharmaceutical industry, maintaining the purity and quality of solid dosage forms, particularly enteric tablets, is crucial. Enteric tablets, designed to withstand the acidic environment of the stomach and dissolve in…

Solid Dosage form, Tablets

Managing Punch Adhesion Issues in Tablet Pressing Operations

March 2, 2025 Admin

Managing Punch Adhesion Issues in Tablet Pressing Operations Managing Punch Adhesion Issues in Tablet Pressing Operations Introduction: The process of tablet pressing is a critical stage in the production of solid dosage forms. One of the common issues faced during this process is punch adhesion, which can significantly affect the quality and consistency of the…

Solid Dosage form, Tablets

Difficulty in implementing automated quality assurance systems.

March 2, 2025 Admin

Difficulty in implementing automated quality assurance systems. Difficulty in Implementing Automated Quality Assurance Systems in Capsule Manufacturing Introduction: In the fast-evolving pharmaceutical industry, maintaining high standards of quality assurance is paramount. Automated quality assurance systems are increasingly being adopted to ensure consistent product quality, reduce human error, and enhance operational efficiency. This is particularly crucial…

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

Troubleshooting Non-Adherence to Cleanroom Validation Standards for Particle Monitoring

March 2, 2025 Admin

Troubleshooting Non-Adherence to Cleanroom Validation Standards for Particle Monitoring Troubleshooting Non-Adherence to Cleanroom Validation Standards for Particle Monitoring Introduction: In the pharmaceutical industry, maintaining a pristine environment is paramount to ensuring product quality and patient safety. Cleanrooms play a crucial role in this process, particularly in the manufacturing of solid dosage forms like tablets. A…

Solid Dosage form, Tablets

Resolving Weight Variation Failures in Bilayer Tablets

March 2, 2025 Admin

Resolving Weight Variation Failures in Bilayer Tablets Resolving Weight Variation Failures in Bilayer Tablets Introduction: In the pharmaceutical industry, bilayer tablets have emerged as a sophisticated solution for delivering multiple drugs or achieving different release profiles in a single dosage form. However, maintaining uniform weight across these tablets poses significant challenges, impacting quality and efficacy….

Solid Dosage form, Tablets

Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing

March 2, 2025 Admin

Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing Introduction: In the pharmaceutical industry, the aesthetic and functional integrity of sugar-coated tablets is paramount. The coating not only enhances the appearance but also affects consumer perception and compliance. However, during accelerated stability testing, a crucial phase…

Solid Dosage form, Tablets