Tag: pharmaceutical compliance

Difficulty in ensuring consistent gelatin solution viscosity during production.

April 9, 2025 Admin

Difficulty in ensuring consistent gelatin solution viscosity during production. Difficulty in Ensuring Consistent Gelatin Solution Viscosity During Production Introduction: In the realm of pharmaceutical manufacturing, ensuring the consistent viscosity of gelatin solutions is paramount for producing high-quality capsules, both hard and soft gelatin types. Gelatin serves as a critical component in encapsulation, providing the structural…

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

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

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

Difficulty in validating capsule drying processes for multi-component formulations.

April 8, 2025 Admin

Difficulty in validating capsule drying processes for multi-component formulations. Difficulty in validating capsule drying processes for multi-component formulations. Introduction: In the pharmaceutical industry, the production of solid oral dosage forms such as capsules is a complex process that requires precise control and validation. Capsules, whether hard or soft gelatin, are a popular choice due to…

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

Difficulty in validating cleaning procedures for non-aqueous formulations.

April 7, 2025 Admin

Difficulty in validating cleaning procedures for non-aqueous formulations. Difficulty in Validating Cleaning Procedures for Non-Aqueous Formulations Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to prevent cross-contamination and ensure product quality. This is especially critical when dealing with non-aqueous formulations, often used in the production of capsules, both hard and…

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

Challenges in validating capsule drying equipment for dual-layer formulations.

April 6, 2025 Admin

Challenges in validating capsule drying equipment for dual-layer formulations. Challenges in validating capsule drying equipment for dual-layer formulations. Introduction: In the realm of pharmaceutical manufacturing, the development and validation of dual-layer formulations present unique challenges, particularly in the drying stage of capsule production. The drying process is critical to ensuring the stability, efficacy, and safety…

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

Difficulty in ensuring compliance with capsule stability testing guidelines.

April 5, 2025 Admin

Difficulty in ensuring compliance with capsule stability testing guidelines. Difficulty in ensuring compliance with capsule stability testing guidelines. Introduction: In the pharmaceutical industry, ensuring the stability of solid oral dosage forms, particularly capsules, is crucial for maintaining the efficacy, safety, and quality of medications throughout their shelf life. Capsule stability testing serves as a fundamental…

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

Problems with validating capsule sealing for oil-based fills.

April 5, 2025 Admin

Problems with validating capsule sealing for oil-based fills. Problems with Validating Capsule Sealing for Oil-Based Fills Introduction: In the pharmaceutical industry, capsules serve as an essential dosage form, particularly for delivering oil-based formulations. The encapsulation of oils presents unique challenges, especially in ensuring the integrity and stability of the seal. Validating capsule sealing for oil-based…

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

Poor validation of emergency power systems for critical utility systems.

April 4, 2025 Admin

Poor validation of emergency power systems for critical utility systems. Poor Validation of Emergency Power Systems for Critical Utility Systems Introduction: In the pharmaceutical industry, maintaining an uninterrupted power supply is crucial for ensuring the integrity of processes, safety of personnel, and compliance with stringent regulatory requirements. Emergency power systems are integral to critical utility…

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

Poor reproducibility in API release profiles over the product’s shelf life.

April 4, 2025 Admin

Poor reproducibility in API release profiles over the product’s shelf life. Poor reproducibility in API release profiles over the product’s shelf life. Introduction: The reproducibility of Active Pharmaceutical Ingredient (API) release profiles is a critical component in the pharmaceutical industry, particularly for solid oral dosage forms such as capsules. Ensuring consistent drug release over a…

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

Troubleshooting Heat Damage in API Granules During Drying Validation

April 3, 2025 Admin

Troubleshooting Heat Damage in API Granules During Drying Validation Troubleshooting Heat Damage in API Granules During Drying Validation Introduction: In the pharmaceutical industry, the drying process of Active Pharmaceutical Ingredient (API) granules is a critical step in the production of solid dosage forms such as tablets. Ensuring the stability and integrity of APIs during drying…

Solid Dosage form, Tablets

Addressing Seal Delamination Issues in Strip Packs for Hygroscopic Tablets

April 2, 2025 Admin

Addressing Seal Delamination Issues in Strip Packs for Hygroscopic Tablets Addressing Seal Delamination Issues in Strip Packs for Hygroscopic Tablets Introduction: In the pharmaceutical industry, the packaging of hygroscopic tablets presents unique challenges due to their sensitivity to moisture. Hygroscopic tablets are designed to absorb moisture from the environment, which can compromise the tablet’s integrity…

Solid Dosage form, Tablets