Tag: FDA Gelatin Guidelines

Challenges in ensuring consistent gelatin solution pH during production.

May 1, 2025 Admin

Challenges in ensuring consistent gelatin solution pH during production. Challenges in ensuring consistent gelatin solution pH during production. Introduction: In the pharmaceutical industry, the production of capsules, specifically those made of gelatin, is a meticulous process that requires precise control over various parameters. Among these, maintaining a consistent pH level in gelatin solutions is crucial….

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

Challenges in validating temperature controls for gelatin solution preparation tanks.

April 1, 2025 Admin

Challenges in validating temperature controls for gelatin solution preparation tanks. Challenges in Validating Temperature Controls for Gelatin Solution Preparation Tanks Introduction: The pharmaceutical industry demands precision and reliability in every aspect of drug manufacturing, especially when it comes to solid oral dosage forms such as capsules. Gelatin, a key ingredient in both hard and soft…

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

Inadequate systems for monitoring gelatin cross-linking during validation.

March 3, 2025 Admin

Inadequate systems for monitoring gelatin cross-linking during validation. Inadequate systems for monitoring gelatin cross-linking during validation. Introduction: Gelatin capsules, both hard and soft gelatin, are widely used in the pharmaceutical industry due to their versatility and patient compliance benefits. However, one of the key challenges faced during the formulation and manufacturing of gelatin capsules is…

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