Showing posts with label GLP. Show all posts
Sep 11, 2026

Out of Trend (OOT) Results in Pharmaceutical Quality Control

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An analytical result does not necessarily have to exceed the specification limit in order to warrant concern regarding product quality. In t...
Aug 31, 2026

Calibration Records in Pharmaceutical Manufacturing

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Calibration records are critical quality records kept by pharmaceutical manufacturers. A long list of measuring instruments is frequently us...
Aug 26, 2026

Documentation Gaps in Pharmaceutical GMP Systems

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Documentation refers to the records of various events throughout the process of pharmaceutical manufacturing. In reality, however, this term...
Jul 31, 2026

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...
Apr 13, 2026

Principle and Working of pH Meter | pH Probes Explained

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The measurement of pH is critical analytical measurement in the pharma industry. Drug stability, solubility, bioavailability and therefore, ...
Mar 26, 2026

Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals

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Pharmaceutical quality systems rely heavily on data integrity as a fundamental element. The accuracy, reliability and completeness of data a...
Mar 15, 2026

Best Practices for Isolator Technology in Pharmaceutical Manufacturing

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Ensuring that sterile and contamination free environments are maintained has become even more critical for manufacturers of sterile pharmace...
Feb 10, 2026

Tips for Hazardous Chemical Handling in Laboratories

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Working with hazardous chemicals can have a serious risk to health if are used incorrectly and without the necessary training or safety prec...
Jan 23, 2026

Limitations and Advances in Dissolution Testing in Pharma

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Dissolution testing has always been important for both gathering data about your form and also as part of product quality control. Dissolved...
Dec 21, 2025

Components of Good Manufacturing Practices (GMP)

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Pharmaceutical Quality Assurance is established through Good Manufacturing Practices (GMP). GMP provides a structured framework to ensure th...
Nov 26, 2025

Understanding GxP in Pharmaceuticals

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One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collecti...
Nov 14, 2025

21 CFR Part 11 Requirements for Laboratories

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In pharmaceutical laboratories electronic data systems have replaced paper documentation. Instruments like HPLC, GC, Spectrophotometer and s...
May 7, 2025

How to Strengthen Microbiological Control of Non-Sterile Pharmaceuticals

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Microbiological quality of pharmaceutical products is essential for patient safety and product stability. As we know, the sterile products a...
Apr 28, 2025

Best Practices in Pharmaceutical Microbiology Laboratory

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Microbiology lab in the pharmaceutical industry helps to identify microbial contamination in pharmaceutical products. Critical analysis like...
Mar 3, 2025

Build a Quality Culture in Pharmaceuticals

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Quality of pharmaceutical products is a major concern in the pharmaceutical industry. Quality of product indicates the seriousness of the ma...
Feb 28, 2025

Determination of Hot and Cold Spot in Stability Chamber

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Everything from pharmaceutical products to personal consumer products is tested in stability chambers to get an accurate reading of conditi...
Feb 18, 2025

Relative Response Factor (RRF) and its Calculation in HPLC Analysis

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During the manufacturing process of active pharmaceutical ingredients, some unwanted substances are produced those are known as impuritie...
Feb 5, 2025

Steps for HPLC Method Development

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Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, opera...
Jan 31, 2025

Steps for Analytical Method Development

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Analytical methods in chemistry context entail how chemical components in natural materials or synthetic materials are identified, separated...
Jan 29, 2025

Importance of Microbiological Analysis in Cleaning Method Validation

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Cleaning Method validation is the process in which documentation of how the cleaning process of manufacturing equipment is done. Most times ...