Jan 4, 2026
Building Better Pharmaceutical Manufacturing Facilities | A Guide to GMP Compliant Design
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The quality of pharmaceutical products starts long before the actual manufacturing process starts. It starts with the infrastructure of the ...
Jan 3, 2026
Ultrasonic Cleaning in Pharmaceuticals | Process, Validation and Benefits
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Pharmaceutical cleaning is not only the best practice to keep your manufacturing operation clean. It is also a critical regulatory and quali...
Jan 2, 2026
How FDA Inspections are Conducted in Pharmaceutical Manufacturing Facilities
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FDA is responsible to make sure that pharmaceutical products in the market are safe, effective and of high quality. FDA regularly inspects d...
Jan 1, 2026
Performance Qualification (PQ) in Pharmaceuticals | Process, Protocol & GMP Compliance
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In the field of pharmaceutical manufacturing, producing a high-quality product is not related to how well you design and install equipment b...
Dec 31, 2025
Operational Qualification (OQ) in Pharmaceuticals | Steps, Testing & GMP Requirements
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All processes and equipment within pharmaceutical manufacturing must function correctly at all times, not just sometimes or nearly correctly...
Dec 30, 2025
Installation Qualification (IQ) in Pharmaceuticals | Purpose, Procedure and Documentation
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The qualification of equipment in pharmaceutical manufacturing is not simply a compliance requirement. But it is part of the scientific proc...
Dec 29, 2025
Design Qualification (DQ) in Pharmaceuticals | Purpose, Process and Documentation
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Equipment, systems, and components used throughout the pharmaceutical manufacturing process are essential to ensuring the safety, quality an...
Dec 28, 2025
Quality Risk Management (QRM) in Pharmaceuticals | ICH Q9 Guidelines, Process & Tools
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To guarantee that their products are safe, effective, and of the best quality before being distributed to patients, the pharmaceutical indus...
Dec 27, 2025
User Requirement Specification (URS) in Pharmaceuticals | Purpose, Format and Examples
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The User Requirements Specification (URS) is the initial document that establishes the quality and regulatory compliance of all instruments,...
Dec 26, 2025
Site Acceptance Test (SAT) in Pharmaceuticals | Process, Protocol & GMP Compliance
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The qualification of equipment in the manufacturing of pharmaceuticals is an organized approach to confirm that the systems perform as expec...
Dec 25, 2025
Factory Acceptance Test (FAT) in Pharmaceuticals | Process, Protocol & Importance
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In the pharmaceutical industry, the equipment and automated systems must be tested for reliability before being installed into a manufacturi...
Dec 21, 2025
GMP in Detail | Components of Good Manufacturing Practices
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Pharmaceutical Quality Assurance is established through Good Manufacturing Practices (GMP). GMP provides a structured framework to ensure th...
Dec 20, 2025
Difference Among Calibration, Validation and Qualification | Explained with Examples
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To ensure the quality, consistency, and compliance of pharmaceutical products, controlled and reliable equipment, systems and processes are ...
Dec 19, 2025
Validation of Excel Calculation Sheets in Pharmaceuticals | Complete Step by Step GMP Guide
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The pharmaceutical industry relies on Microsoft Excel very much for several GMP related activities such as calculating assay results, genera...
Dec 18, 2025
Facility Qualification in Pharmaceuticals | Steps, Stages & GMP Requirements
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Facility qualification is an essential step at the beginning of implementation of Good Manufacturing Practices in any pharmaceutical manufac...
Dec 9, 2025
Current Good Manufacturing Practices (cGMP) | Complete GMP Guide for Pharmaceuticals
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All products manufactured in pharmaceutical facilities must meet three criteria; safety, effectiveness and consistency in their quality. To ...
Dec 8, 2025
Understanding 21 CFR | FDA Compliance Guidelines for Pharmaceutical Manufacturers
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Companies in the pharmaceutical industry focused on meeting regulatory and international standard requirements must be aware of the regulati...
Dec 6, 2025
Quality Management System (QMS) in Pharmaceuticals | Complete Guide to GMP Compliance
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Product quality in pharmaceutical industry is not optional but it is a primary regulatory requirement for every company those manufactures p...
Dec 4, 2025
Schedule M Compliance | Complete Guide for Pharmaceutical Manufacturers
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Schedule M is a part of Drug and Cosmetic Rules, 1945. It provides good manufacturing practices (GMP) requirements for pharmaceutical indust...
Dec 2, 2025
Validation of Shelf Life for 70% v/v Isopropyl Alcohol | IPA Efficacy Validity Determination
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Isopropyl alcohol 70% is one of the most commonly used disinfectants and the pharmaceutical industry. It is used for surface disinfection, e...
Dec 1, 2025
USFDA Guidelines for Pharmaceuticals | Complete FDA Compliance Guide
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USFDA has great importance in ensuring the safety, efficacy and quality of pharmaceutical products sold in the United States market. The gui...
Nov 29, 2025
Purified Water Systems in Pharmaceuticals | Types, Design and Uses
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One of the most pronounced ingredients in any pharmaceutical engineering is water. Water serves as a solvent and ingredient for formulation ...
Nov 28, 2025
Color Codes for the Gas Cylinders in Pharmaceuticals | ISO and BIS Color Codes
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Gas cylinders are widely used for various purposes in pharmaceutical industry from sterile operations and laboratory testing to manufacturin...
Nov 26, 2025
Understanding GxP in Pharmaceuticals | Types, Purpose and Importance of GxP
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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 24, 2025
Different Mesh Sizes and Mesh to Micron Conversion
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Sieves and screens are widely used in pharmaceutical manufacturing as well as in the quality control to determine the particle size of the r...
Nov 21, 2025
Purified Water System Validation | Steps, Phases and Compliance Guide
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In pharmaceutical industry, water is the most critical utility used in manufacturing process and washing of equipment. It is used as the raw...
Nov 20, 2025
Sustained Release and Prolonged Release Tablets and their Difference
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In modern drug delivery the focus is not just on developing new molecules but on achieving maximum therapeutic benefits from the dose with m...
Nov 18, 2025
Lessons from Major Regulatory Non-Compliance Cases
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In the pharmaceutical industry, regulatory compliance is not optional but it is the foundation of trust, product safety and patient health. ...
Nov 16, 2025
Basics of HVAC System | HVAC Components, Working and Airflow Diagram
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Air conditioning has changed over the years, the HVAC system is used to control the environment in the manufacturing as well as the storage ...
Nov 14, 2025
21 CFR Part 11 Requirements for Laboratories | Tips for Compliance
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In pharmaceutical laboratories electronic data systems have replaced paper documentation. Instruments like HPLC, GC, Spectrophotometer and s...