Tag: Environmental Monitoring

If you don’t find what you are looking for, try using a different term or contact us.

Mold contamination in cleanrooms featured image showing mold growth on an agar plate under laboratory light.

Mold Contamination in Cleanrooms: An Invisible but Critical Threat

Even modern cleanrooms face mold risks from HVAC systems, materials, and humidity. Understand how maintenance and monitoring programs can prevent...
fda-warning-letter-analysis

FDA Warning Letter to Somerset Therapeutics Pvt. Ltd. (India) Issued September 2025

FDA issues Warning Letter to Somerset Therapeutics citing major cGMP failures in aseptic practices, investigations, and reporting....

Cleanroom Classification According to ISO 14644-1

ISO 14644-1 cleanroom classification explained: particle limits, GMP grade mapping, and key compliance insights for sterile pharma manufacturing....
environmental monitoring in pharmaceutical industry - featured image

Environmental Monitoring in the Pharmaceutical Industry

Essential strategies for environmental monitoring in pharma to ensure GMP compliance, prevent contamination, and maintain cleanroom control....
Contamination Control Strategy Featured Image

Risk-Based Contamination Control Strategy (CCS)

Learn how to build a risk-based Contamination Control Strategy (CCS) that meets Annex 1 (2022) expectations. Discover the key elements,...
rabs-vs-isolators-fi

RABS vs Isolators: Which Barrier System Meets Annex 1 Expectations?

RABS vs Isolators: Key differences, Annex 1 expectations, and how to choose the right barrier system for your aseptic manufacturing...
fda-warning-letter-analysis

FDA Warns Aspen SA Sterile Operations for CGMP Violations in Lab Controls, Aseptic Practices, Data Integrity, and Environmental Monitoring

The FDA has issued a warning letter to Aspen SA Sterile Operations for serious CGMP violations, including failures in lab...
Types of Sampling Methods in Environmental Monitoring

Types of Sampling Methods in Environmental Monitoring

Explore key sampling methods in environmental monitoring, like air, surface, and personnel sampling, to ensure GMP compliance and maintain cleanroom...
Cleanroom Qualification and Validation in GMP

Cleanroom Qualification and Validation in GMP

Explore the critical steps of cleanroom qualification and validation within GMP environments, emphasizing the importance of design, operational standards, and...

BECOME A GMP INSIDER

Stay in touch and be the first to get the latest GMP News!