Validation Failure Due to Poor Risk Assessment: Case Study
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Validation failures are usually due to improper testing, equipment failure, or mistakes made by the operator. One of the most common causes ...
Validation Report in Pharmaceuticals: A Practical Guide
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Validation tests do not finish once the testing phase has been accomplished. A good validation report proves the outcome of the validation p...
Best Practices for Reviewing Validation Documents
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Validation documents go beyond regulatory documentation; they are written proof that the pharmaceutical premises, equipment, utilities, comp...
Documentation Practices That Impress Inspectors
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During an inspection by regulatory authorities, various documentation reveal the working of a pharmaceutical facility. Although inspectors s...
Troubleshooting Inconsistent Batch Performance in Pharmaceuticals
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The core of pharmaceutical production is the concept of batch consistency. Every batch must conform with all predetermined specifications re...
Inspection Readiness Timeline for GMP Inspections
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An inspection carried out according to regulations is one of the major moments in the life of a pharmaceutical production plant. Regardless ...
Root Cause Analysis of Failed Cleaning Validation: A Practical Guide
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One of the hardest experiences that any pharmaceutical company could encounter is the failure of the cleaning validation process. There are ...
Utility Design Considerations for Efficient Pharmaceutical Manufacturing
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When pharmaceutical specialists speak about way of manufacturing effectiveness, they usually emphasize machinery, machinery automation or im...
Steps to Calculate MACO for Cleaning Validation in Pharmaceuticals
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Cleaning validation is one of the most studied and analyzed processes during the pharmaceutical inspections since it demonstrates that the c...
Worst-Case Product Selection Using Risk Assessment in Validation
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Verification tools are always limited although many pharmaceutical manufacturing sites manufacture various products utilizing the same machi...
How to Perform a Mock Audit to Simulate a Regulatory Inspection
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Each pharmaceutical producer hopes to successfully emerge from a regulatory inspection, which is not possible just because it wishes to do s...
How to Calculate Sampling Size of Raw Materials | n, p and r Plans
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When raw materials are delivered to a manufacturing plant, they pose a threat to the quality of finished goods. The quality department canno...
Eliminating Dead Legs in Pharmaceutical Piping Systems
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The piping systems and water systems are made to carry vital services like PW, WFI, pure steam, process gases and CIP solutions without comp...
Validation of Dissolution Methods in Pharmaceutical Analysis
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Dissolution testing is recognized as one of the primary quality control tests for solid dosage forms. It shows how quickly and how much of t...
Validation Policy in Pharmaceuticals | Purpose, Scope and Benefits
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Validation is one of the main aspects of pharmaceutical quality assurance. It establishes documented proof that facilities, utilities, equip...
Validation of Electronic Logbooks in Pharmaceutical Manufacturing
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Because of the need to enhance efficiency and to minimize data errors and strengthen data integrity, the pharmaceutical sector is currently ...
Recovery Factor Studies in Cleaning Validation: A Practical Guide
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Cleaning validation plays a vital role in manufacturing as it ensures that all manufacturing equipment is being cleaned according to the set...
Common Audit Findings in Analytical Method Validation
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Analytical method validation establishes documentation for how an analytical test procedure is adequate for meeting its intended use. When t...
Water System Validation After Major Maintenance in Pharmaceuticals
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One of the most important utility systems at any manufacturing site is the pharmaceutical water system. Depending on whether purified water,...
Smoke Study Mistakes and Solutions in Pharmaceutical Cleanrooms
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One of the most essential qualifications performed within sterile pharmaceutical manufacturing facilities is the execution of smoke studies ...
Cleaning Validation Failures and Their Root Causes in Pharmaceuticals
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Validation of cleaning processes is an essential function in the pharmaceutical industry by providing documented proof that manufacturing eq...
Common FDA 483 Observations Related to Process Validation
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The validation of processes is one of the major cornerstones of manufacturing in the pharmaceutical industry. The process of Validation prov...
Handling Unexpected Validation Results in Pharmaceutical Manufacturing
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The purpose of validation activities is to provide evidence that pharmaceutical processes, equipment and utilities, computerized systems and...
How to Draft an Irresistible Response to an FDA 483 Observation
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For any pharmaceutical manufacturer, having an open FDA 483 is one of the more difficult situations to experience. The inspection has conclu...
Risk Assessment in Pharmaceuticals | Principles and Applications
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Manufacturing pharmaceuticals entails many processes and systems, equipment and personnel activities that can impact the quality of the prod...
CAPA Effectiveness Evaluation Methods in Pharmaceuticals
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The Corrective and Preventive Actions (CAPA) System is a critical aspect of managing the quality of pharmaceuticals. At the same time, CAPA ...
Working Culture in USFDA Approved Pharmaceutical Plants
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A USFDA approved pharmaceutical plant is not simply a manufacturing location that has passed an inspection; it is a facility that has qualit...
Validation of Pharmaceutical Utilities | GMP Requirements
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Utility systems for pharmaceuticals are essential elements for a manufacturing enterprise because they affect product quality and environmen...
FDA Forms Generally Used in Pharmaceutical Inspection
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Regulatory inspections are a fundamental part of the pharmaceutical manufacturing process. They allow a company to verify compliance with Cu...
GMP Documentation Errors and Solutions in Pharmaceuticals
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The foundation of quality systems in the manufacturing and distribution of pharmaceuticals is based upon the documentation of work performed...
