GMP Insiders - Your trusted source for GMP compliance!

Category: Articles

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

Improve supplier qualification management through practical GMP steps, detailed checklists, audits, and ongoing performance monitoring....
IDMP Ontology explained: how it supports regulatory data, improves data governance, and prepares your pharma organization for SPOR and ISO...
Explore the critical role of Clean Hold Time (CHT) and Dirty Hold Time (DHT) in cleaning validation. This in-depth guide...
GMP vs cGMP—understand what “current” means for today’s quality standards, compliance expectations, and pharma manufacturing practices...
Media fill tests verify aseptic process integrity by simulating sterile drug manufacturing under worst-case conditions to ensure contamination control....
Overview of Bill of Materials in GMP-compliant pharmaceutical manufacturing, including materials, compliance, traceability, version control, and integration....
Essential strategies for environmental monitoring in pharma to ensure GMP compliance, prevent contamination, and maintain cleanroom control....
Growth Promotion Testing (GPT) verifies culture media performance to support microbial growth in pharmaceutical microbiology applications....
Discover global strategies for FDA Inspection Readiness, real-time GMP compliance, and regulatory confidence....
Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the...

BECOME A GMP INSIDER

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