Tag: [Batch records

Managing Deviations in Batch Records for Enteric-Coated Tablets

May 9, 2025 Admin

Managing Deviations in Batch Records for Enteric-Coated Tablets Managing Deviations in Batch Records for Enteric-Coated Tablets Introduction: In the pharmaceutical industry, maintaining the integrity of batch records is crucial for ensuring the quality and compliance of drug products. Enteric-coated tablets, designed to withstand the acidic environment of the stomach and dissolve in the more neutral…

Solid Dosage form, Tablets

Challenges in maintaining proper records for batch-specific quality deviations.

April 21, 2025 Admin

Challenges in maintaining proper records for batch-specific quality deviations. Challenges in maintaining proper records for batch-specific quality deviations Introduction: In the pharmaceutical industry, maintaining precise and thorough records of batch-specific quality deviations is vital for ensuring product safety and regulatory compliance. These records are essential for tracking the history of a product, identifying the root…

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

Addressing Deviations in Batch Records for Multi-Layer Tablets

March 28, 2025 Admin

Addressing Deviations in Batch Records for Multi-Layer Tablets Addressing Deviations in Batch Records for Multi-Layer Tablets Introduction: In the pharmaceutical industry, the production of multi-layer tablets presents unique challenges due to their sophisticated structure and intricate manufacturing process. Multi-layer tablets are designed to deliver multiple active pharmaceutical ingredients (APIs) or to provide controlled release profiles,…

Solid Dosage form, Tablets

High variability in documentation practices for batch records.

March 18, 2025 Admin

High variability in documentation practices for batch records. High Variability in Documentation Practices for Batch Records Introduction: In the pharmaceutical industry, maintaining precise and consistent documentation practices for batch records is critical. These records serve as the blueprint of manufacturing processes, ensuring that each batch of product meets stringent quality standards. However, high variability in…

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