Tag: Good Manufacturing Practice

Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing

June 2, 2025 Admin

Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing Introduction: In the pharmaceutical industry, the manufacturing of enteric-coated tablets requires stringent environmental controls to ensure product integrity and patient safety. The role of Heating, Ventilation, and Air Conditioning (HVAC) systems in maintaining cleanroom conditions is critical. These systems…

Solid Dosage form, Tablets

Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation

May 25, 2025 Admin

Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation Introduction: The sugar-coating process in pharmaceutical manufacturing plays a crucial role in enhancing the aesthetic appeal, taste masking, and stability of tablets. However, managing residual solvent build-up during this process, particularly in the coating pans, is a…

Solid Dosage form, Tablets

Problems with validating capsule drying trays for uniform heat distribution.

April 15, 2025 Admin

Problems with validating capsule drying trays for uniform heat distribution. Problems with validating capsule drying trays for uniform heat distribution. Introduction: In the pharmaceutical industry, the drying process of capsules is a critical step that directly affects the quality and stability of the final product. Proper drying ensures that moisture content is reduced to a…

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

Common Issues in Batch Sampling for Quality Testing of Tablets

March 19, 2025 Admin

Common Issues in Batch Sampling for Quality Testing of Tablets Common Issues in Batch Sampling for Quality Testing of Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of tablet batches is paramount. Batch sampling is a critical process that involves selecting a representative sample from a production batch to assess the quality…

Solid Dosage form, Tablets

Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets

March 14, 2025 Admin

Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets Introduction: Extended release tablets are a crucial innovation in pharmaceutical dosage forms, designed to release active pharmaceutical ingredients (APIs) over an extended period. This delivery system improves patient adherence, optimizes therapeutic outcomes, and reduces dosing frequency. However,…

Solid Dosage form, Tablets

Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing

March 6, 2025 Admin

Solid Dosage form, Tablets

Ensuring Compliance with GMP Standards in Utility Validation Documentation

March 1, 2025 Admin

Ensuring Compliance with GMP Standards in Utility Validation Documentation Ensuring Compliance with GMP Standards in Utility Validation Documentation Introduction: The pharmaceutical industry operates under strict regulations to ensure the safety, quality, and efficacy of products. Good Manufacturing Practice (GMP) standards are integral to these regulations, guiding the production, testing, and quality assurance of pharmaceutical products….

Solid Dosage form, Tablets