Tag: EMA

Difficulty in monitoring gelatin solution temperature during preparation.

April 18, 2025 Admin

Difficulty in monitoring gelatin solution temperature during preparation. Difficulty in Monitoring Gelatin Solution Temperature During Preparation Introduction: In the pharmaceutical industry, the preparation of gelatin solutions is a critical step in the manufacturing of both hard and soft gelatin capsules. Maintaining the appropriate temperature of the gelatin solution is crucial for ensuring the quality and…

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

Challenges in validating cleaning procedures for encapsulation lines shared across products.

April 14, 2025 Admin

Challenges in validating cleaning procedures for encapsulation lines shared across products. Challenges in Validating Cleaning Procedures for Encapsulation Lines Shared Across Products Introduction: In the pharmaceutical industry, ensuring the cleanliness of encapsulation lines that are shared across different products is critical. This process is not only essential for maintaining product integrity but also for adhering…

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

Difficulty in ensuring compliance with bioequivalence requirements for capsules.

April 9, 2025 Admin

Difficulty in ensuring compliance with bioequivalence requirements for capsules. Difficulty in ensuring compliance with bioequivalence requirements for capsules. Introduction: In the pharmaceutical industry, ensuring that generic formulations are bioequivalent to their branded counterparts is crucial. Bioequivalence ensures that a generic drug releases its active ingredient into the bloodstream at the same rate and level as…

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

Problems with ensuring compliance with pharmacovigilance requirements.

March 12, 2025 Admin

Problems with ensuring compliance with pharmacovigilance requirements. Problems with ensuring compliance with pharmacovigilance requirements. Introduction: Pharmacovigilance plays a critical role in the pharmaceutical industry, ensuring the safety and efficacy of drugs throughout their lifecycle. Compliance with pharmacovigilance requirements is essential for maintaining drug safety, protecting patient health, and fulfilling regulatory obligations. However, achieving and maintaining…

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

Validating Adequacy of Clean Steam Systems for Film-Coating Equipment

March 2, 2025 Admin

Validating Adequacy of Clean Steam Systems for Film-Coating Equipment Validating Adequacy of Clean Steam Systems for Film-Coating Equipment Introduction: In the pharmaceutical industry, ensuring the adequacy of clean steam systems is crucial for the successful operation of film-coating equipment used in tablet production. Clean steam, often used for sterilization and process control, must be free…

Solid Dosage form, Tablets