Category: Manufacturing

The Manufacturing category covers the processes, equipment, and controls that ensure pharmaceutical production meets GMP requirements.

Topics include raw material handling, granulation, packaging, process validation, cleaning validation, qualification activities, and risk-based approaches in line with EU GMP and FDA standards. Supporting areas such as environmental controls, batch records, and manufacturing documentation are also addressed.

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Challenge Tests for Blister Machines

Challenge Tests for Blister Machines

Explore the significance of challenge tests for blister machines in the pharmaceutical industry, ensuring the detection and rejection of defective...
Laminar Flow Cabinets - LFC - Types and Applications in GMP Facilities

Laminar Flow Cabinets in GMP Facilities: Types & Application

Discover the importance, types, and regulatory requirements of laminar flow cabinets in GMP regulated environment....
The role of Batch Manufacturing Records - BMR in GMP

The Role of Batch Manufacturing Records (BMR) in GMP

Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards....
Worst Case Selection in Cleaning Validation

Worst Case Selection in Cleaning Validation

Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy....
Person Performing Process Validation Lifecycle

Process Validation Lifecycle: Risk-Based Approach

Discover the essentials of Process Validation Lifecycle with a risk-based approach. Learn how to ensure product integrity from development to...
People performing Process Validation in GMP facility

Process Validation in GMP

Discover the essentials of Process Validation in GMP, ensuring pharmaceutical quality through scientific and regulatory practices....
FAT and SAT in GMP Importance in Equipment Validation

FAT and SAT in GMP: Importance in Equipment Validation

Exploring Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) - essential steps in ensuring equipment quality and compliance in...
GMP vs GLP - 10 Key Aspects for Quality and Compliance

GMP vs GLP: 10 Key Differences for Quality and Compliance

Explore the key differences of GMP vs GLP and how these practices warrant the highest industry standards....
Cleaning Validation of Equipment in Pharmaceutical Industry

Cleaning Validation In the Pharmaceutical Industry

Explore the essentials of cleaning validation in the pharmaceutical industry, including all necessary steps, challenges, and regulatory standards....

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