Tag: root cause analysis

Troubleshooting Non-Conformance in Dissolution Testing Protocols

May 26, 2025 Admin

Troubleshooting Non-Conformance in Dissolution Testing Protocols Troubleshooting Non-Conformance in Dissolution Testing Protocols Introduction: Dissolution testing plays a crucial role in the pharmaceutical industry, ensuring that solid dosage forms like tablets release their active ingredients at the desired rate. When these protocols encounter non-conformance, it can lead to significant setbacks in drug development and manufacturing. Understanding…

Solid Dosage form, Tablets

Root Cause Analysis of Weight Variation in Tablets During Stability Storage

May 24, 2025 Admin

Root Cause Analysis of Weight Variation in Tablets During Stability Storage Root Cause Analysis of Weight Variation in Tablets During Stability Storage Introduction: In the pharmaceutical industry, tablets remain one of the most common solid dosage forms, prized for their convenience, stability, and precise dosing. However, a critical aspect of tablet production and storage is…

Solid Dosage form, Tablets

Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets

May 19, 2025 Admin

Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets Introduction: The pharmaceutical industry is committed to ensuring that medications are safe, effective, and of the highest quality. One critical aspect of this commitment is dissolution testing, particularly for enteric-coated tablets. These tablets…

Solid Dosage form, Tablets

Addressing Root Cause Analysis for Failures in Weight Variation Tests

April 17, 2025 Admin

Addressing Root Cause Analysis for Failures in Weight Variation Tests Addressing Root Cause Analysis for Failures in Weight Variation Tests Introduction: In the pharmaceutical industry, ensuring the consistency and quality of solid dosage forms like tablets is paramount. One critical quality control measure is the weight variation test, which evaluates the uniformity of tablet weights…

Solid Dosage form, Tablets

Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies

April 3, 2025 Admin

Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies Introduction: Stability studies are a crucial component of the pharmaceutical development process, ensuring that drug products maintain their intended quality, safety, and efficacy throughout their shelf life. Non-adherence to stability protocols can lead to significant issues, including…

Solid Dosage form, Tablets

Poor enforcement of corrective and preventive action (CAPA) programs.

April 3, 2025 Admin

Poor enforcement of corrective and preventive action (CAPA) programs. Poor enforcement of corrective and preventive action (CAPA) programs. Introduction: Corrective and Preventive Action (CAPA) programs serve as a cornerstone in pharmaceutical quality management systems. Their primary goal is to identify, address, and mitigate quality issues, ensuring that products meet regulatory standards and patient safety requirements….

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

Difficulty in conducting root cause analysis for capsule quality failures.

April 2, 2025 Admin

Difficulty in conducting root cause analysis for capsule quality failures. Difficulty in conducting root cause analysis for capsule quality failures. Introduction: The pharmaceutical industry is tasked with the critical responsibility of ensuring that all medicinal products are safe, effective, and of the highest quality. Capsules, both hard and soft gelatin, are among the most common…

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

Investigating Root Causes of Hardness Variability in Coated Tablets

March 31, 2025 Admin

Investigating Root Causes of Hardness Variability in Coated Tablets Investigating Root Causes of Hardness Variability in Coated Tablets Introduction: The pharmaceutical industry is committed to ensuring the quality, efficacy, and safety of its products. Among the various dosage forms, coated tablets are one of the most commonly used due to their convenience, stability, and ease…

Solid Dosage form, Tablets

Root Cause Analysis of Failures in Weight Uniformity Tests

March 26, 2025 Admin

Root Cause Analysis of Failures in Weight Uniformity Tests Root Cause Analysis of Failures in Weight Uniformity Tests Introduction: In the realm of pharmaceutical manufacturing, ensuring the consistency and quality of dosage forms is paramount. One of the critical quality control tests for solid dosage forms, specifically tablets, is the weight uniformity test. This test…

Solid Dosage form, Tablets

Managing Root Cause Analysis for Failures in Stability Studies

March 22, 2025 Admin

Managing Root Cause Analysis for Failures in Stability Studies Managing Root Cause Analysis for Failures in Stability Studies Introduction: In the pharmaceutical industry, stability studies are crucial to ensuring that a drug product maintains its intended quality, safety, and efficacy throughout its shelf life. Failures in stability studies can lead to significant setbacks in drug…

Solid Dosage form, Tablets

Root Cause Analysis for Failures in Coating Layer Adhesion Tests

March 21, 2025 Admin

Root Cause Analysis for Failures in Coating Layer Adhesion Tests Root Cause Analysis for Failures in Coating Layer Adhesion Tests Introduction: The pharmaceutical industry continually strives to optimize the quality and efficiency of its products. Among the various solid dosage forms, tablets are particularly popular due to their stability, ease of administration, and manufacturing efficiency….

Solid Dosage form, Tablets

Identifying Root Causes of Poor Disintegration in Film-Coated Tablets

March 21, 2025 Admin

Identifying Root Causes of Poor Disintegration in Film-Coated Tablets Identifying Root Causes of Poor Disintegration in Film-Coated Tablets Introduction: Film-coated tablets are a popular solid dosage form in the pharmaceutical industry due to their enhanced stability, ease of ingestion, and ability to mask unpleasant tastes. However, one critical quality attribute for these tablets is their…

Solid Dosage form, Tablets