Mar 19, 2025
Design Qualification (DQ) of Equipment
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Design qualification is defined as a verification process on the design to meet particular requirements relating to the quality of pharmaceu...
Mar 18, 2025
How to Write a Validation Protocol?
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A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specificat...
Mar 17, 2025
Criteria to Choose the Correct Swab for Cleaning Validation
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In pharmaceutical manufacturing, the product must not be contaminated by previous product as well as it should not be contaminated with the ...
Mar 13, 2025
Concept of Revalidation in Pharmaceuticals
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The revalidation process is essential to maintain the validated status of the plant, equipment, manufacturing processes, and computer syste...
Mar 11, 2025
Transport Validation for Pharmaceutical Products
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In the past, it was not important to validate the transportation of the pharmaceutical products but now it is recommended by all major re...
Mar 9, 2025
FDA Warning Letters for Cleaning Validation
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Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978....
Cleaning Validation of Pharmaceutical Equipment
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The Cleaning validation is performed to demonstrate the effectiveness of procedures for cleaning to remove the residue of the previous pr...
Mar 7, 2025
Different Types of Temperature Sensors
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Temperature sensors are used in different processes in pharmaceuticals. Different types of temperature sensors are used in different proc...
Mar 5, 2025
Preparation of Batch Packaging Record (BPR)
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This Quality Standard describes the requirements for the preparation, generation and approval of new or revised Packaging Masters and Batch ...
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...
Mar 1, 2025
Preparation of Master Formula Record (MFR)
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Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing proce...
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 27, 2025
Requirements for Good Documentation Practice (GDP)
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Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of ...
Feb 26, 2025
Site Acceptance Test (SAT)
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Site Acceptance Test can determine whether or not systems are meeting the desired and required specifications. The main purpose of site acce...
Feb 25, 2025
Working of an Effluent Treatment Plant
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Water is an essential part of manufacturing industry processes and domestic use. Water is used as a coolant, solvent or in many other chemic...
Feb 24, 2025
Self Inspection and Its Implementation in Pharmaceuticals
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Self inspection is basically a very useful and powerful mechanism for detecting any shortcomings or faults operating within any system. It m...
Feb 19, 2025
Case Studies: Troubleshooting Purified Water System Failures
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Purified water in the pharmaceutical industry is a critical component because it is used at various stages of pharmaceutical manufacturing. ...
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 17, 2025
ALCOA Principles of Data Integrity
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Data integrity is highly important in any industry, but especially so in the pharmaceutical industry where any data error could mean serious...
Feb 10, 2025
Purified Water Storage and Distribution System
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The purified water is prepared by purified water generation system ( Reverse Osmosis System ) and collected in purified water storage ta...
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 ...
Jan 28, 2025
Process Validation in Pharmaceutical Manufacturing
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1. Introduction Process validation is an essential part of good manufacturing practices (GMP) . It is, therefore, an element of the qu...
Jan 27, 2025
User Requirement Specification (URS) of Equipments
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User Requirement Specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased. URS is prepared by ...
Jan 24, 2025
Why Cold Chain Logistics are Required in Pharmaceuticals?
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Over the years the pharmaceutical industry has used non-temperature specific drugs as pills for most of its purposes. Cold chain pharmaceuti...
Jan 22, 2025
Contamination Control Strategies for Manufacturing Area
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Contamination is a very serious issue in pharmaceutical manufacturing especially in sterile manufacturing. It is important to control the co...
Jan 21, 2025
Mode of Action of Disinfectant Solutions
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A lot of disinfectants are used for sanitization and disinfection in pharmaceutical industries. These have different antimicrobial proper...
Jan 16, 2025
Validation of Compressed Air
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Compressed air is used in the different areas of the pharmaceutical manufacturing facility. Compressed air may contain contaminants those ma...
Jan 14, 2025
Three Consecutive Batches for Validation in Pharmaceuticals
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This is a common concept to validate three consecutive batches in pharmaceuticals. In process validation , initial three batches are take...