Tag: pharmaceuticals

Validating Rinse Volume Requirements in Cleaning Validation Protocols

May 15, 2025 Admin

Validating Rinse Volume Requirements in Cleaning Validation Protocols Validating Rinse Volume Requirements in Cleaning Validation Protocols Introduction: In the pharmaceutical industry, ensuring that manufacturing equipment is free from contaminants is paramount to product safety and efficacy. Cleaning validation is a critical component of Good Manufacturing Practice (GMP) to confirm that cleaning processes are effective and…

Solid Dosage form, Tablets

Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time

April 13, 2025 Admin

Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time Introduction: Sugar-coated tablets are a popular solid dosage form in the pharmaceutical industry due to their ability to mask unpleasant tastes and improve patient compliance. However, maintaining the potency of the Active Pharmaceutical Ingredient (API)…

Solid Dosage form, Tablets

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

Inadequate systems for reviewing and updating quality-related documents.

April 5, 2025 Admin

Inadequate systems for reviewing and updating quality-related documents. Inadequate Systems for Reviewing and Updating Quality-Related Documents Introduction: In the pharmaceutical industry, maintaining up-to-date and accurate quality-related documents is crucial. These documents ensure compliance with regulatory standards, facilitate efficient operations, and uphold product quality and safety. Despite their significance, many organizations struggle with inadequate systems for…

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

Troubleshooting Layer Delamination in Sugar-Coated Tablets During Validation

March 18, 2025 Admin

Troubleshooting Layer Delamination in Sugar-Coated Tablets During Validation Troubleshooting Layer Delamination in Sugar-Coated Tablets During Validation Introduction: In the pharmaceutical industry, sugar-coated tablets are a popular dosage form due to their aesthetic appeal and taste-masking properties. However, during the critical phase of validation, one of the most common issues encountered is layer delamination. This problem…

Solid Dosage form, Tablets

Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production

March 5, 2025 Admin

Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production Introduction: In the pharmaceutical industry, producing high-quality tablets that meet regulatory standards is crucial. Among various tablet forms, hygroscopic tablets present unique challenges due to their moisture sensitivity. Utility validation is a vital part of ensuring that…

Solid Dosage form, Tablets