Tag: Validation studies

Managing Residual Moisture Issues in Dryers During Cleaning Validation Studies

June 5, 2025 Admin

Managing Residual Moisture Issues in Dryers During Cleaning Validation Studies Managing Residual Moisture Issues in Dryers During Cleaning Validation Studies Introduction: In the pharmaceutical industry, ensuring the cleanliness and safety of manufacturing equipment is crucial to maintaining product integrity and patient safety. Residual moisture in dryers, used in the production of solid dosage forms like…

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

Addressing Residual Detergent Issues in Cleaning Validation Studies

May 3, 2025 Admin

Addressing Residual Detergent Issues in Cleaning Validation Studies Addressing Residual Detergent Issues in Cleaning Validation Studies Introduction: In the pharmaceutical industry, cleaning validation is an essential process to ensure that equipment used in the manufacturing of drugs is properly cleaned, preventing cross-contamination and ensuring product safety and efficacy. One of the critical components of cleaning…

Solid Dosage form, Tablets

Problems with establishing acceptance criteria for cleaning validation studies.

April 26, 2025 Admin

Problems with establishing acceptance criteria for cleaning validation studies. Problems with Establishing Acceptance Criteria for Cleaning Validation Studies Introduction: In the pharmaceutical industry, maintaining cleanliness and preventing cross-contamination are paramount to ensuring product safety and efficacy. Cleaning validation studies are critical components of Good Manufacturing Practice (GMP) compliance. They confirm that cleaning processes consistently produce…

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

Ensuring Compliance with Residual Limits in Cleaning Validation Studies

March 19, 2025 Admin

Ensuring Compliance with Residual Limits in Cleaning Validation Studies Ensuring Compliance with Residual Limits in Cleaning Validation Studies Introduction: In the pharmaceutical industry, maintaining stringent hygiene and cleanliness standards is crucial for ensuring product safety and efficacy. Cleaning validation is an essential component of Good Manufacturing Practices (GMP), particularly in solid dosage forms such as…

Solid Dosage form, Tablets

What are the key principles and objectives of GLP?

July 28, 2023July 28, 2023 Admin

Key Principles and Objectives of GLP Key Principles of GLP Good Laboratory Practice (GLP) is founded on several key principles that guide the conduct of nonclinical laboratory studies: 1. Data Integrity: Ensuring that all data generated during the study is accurate, reliable, and traceable to the original records. Data should be complete, transparent, and free…

GLP Guidelines

What is Good Laboratory Practice (GLP), and why is it important in research?

July 28, 2023July 28, 2023 Admin

Good Laboratory Practice (GLP) and Its Importance in Research Good Laboratory Practice (GLP) is a set of guidelines and regulations that govern the conduct of nonclinical laboratory studies involving chemicals, pharmaceuticals, and other products. GLP ensures the reliability, consistency, and integrity of data generated during these studies, which are used to assess the safety and…

GLP Guidelines

Explain GLP.

July 28, 2023July 28, 2023 Admin

General Understanding of GLP Good Laboratory Practice (GLP) is a set of guidelines and regulations that govern the conduct of nonclinical laboratory studies involving chemicals, pharmaceuticals, and other products. GLP ensures the reliability, consistency, and integrity of data generated during these studies, which are used to assess the safety and efficacy of substances before they…