Tag: Validation Guidelines

Troubleshooting Failures in Cleaning Validation for Coating Equipment

June 1, 2025 Admin

Troubleshooting Failures in Cleaning Validation for Coating Equipment Troubleshooting Failures in Cleaning Validation for Coating Equipment Introduction: In the pharmaceutical industry, the cleaning validation of coating equipment is a critical process that ensures the safety and efficacy of drug products. Cleaning validation verifies that residues from the manufacturing process, including active pharmaceutical ingredients (APIs), excipients,…

Solid Dosage form, Tablets

Addressing Brittleness in Sugar-Coated Tablets During Validation Studies

May 25, 2025 Admin

Addressing Brittleness in Sugar-Coated Tablets During Validation Studies Addressing Brittleness in Sugar-Coated Tablets During Validation Studies Introduction: Sugar-coated tablets have long been a popular choice in pharmaceutical manufacturing due to their aesthetic appeal, ease of swallowing, and ability to mask the taste of active ingredients. However, the process of sugar coating can introduce brittleness, posing…

Solid Dosage form, Tablets

Ensuring Robustness in Disintegration Time During Validation Testing

May 24, 2025 Admin

Ensuring Robustness in Disintegration Time During Validation Testing Ensuring Robustness in Disintegration Time During Validation Testing Introduction: In the pharmaceutical industry, the disintegration time of tablets is a critical quality attribute that directly impacts drug release and bioavailability. Ensuring robustness in disintegration time during validation testing is essential to maintain consistency in therapeutic efficacy and…

Solid Dosage form, Tablets

Challenges in validating cleaning processes for low-dose formulations.

April 4, 2025 Admin

Challenges in validating cleaning processes for low-dose formulations. Challenges in validating cleaning processes for low-dose formulations. Introduction: In the pharmaceutical industry, ensuring that equipment used in the manufacturing of drug products is free from contaminants is crucial. This is especially true for low-dose formulations, where even minimal residuals can affect product safety and efficacy. Cleaning…

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

Ensuring Consistency in Compression Force Across Batches During Equipment Validation

March 6, 2025 Admin

Ensuring Consistency in Compression Force Across Batches During Equipment Validation Ensuring Consistency in Compression Force Across Batches During Equipment Validation Introduction: In the pharmaceutical industry, ensuring consistency in the manufacturing process is crucial for producing high-quality medications. One critical aspect of this is maintaining a consistent compression force during the tablet manufacturing process. Compression force…

Solid Dosage form, Tablets