contract manufacturing – Pharma GMP

FDA Data Integrity Expectations for Contract Manufacturing and Testing

digi — Sat, 15 Nov 2025 08:20:47 +0000

FDA Data Integrity Expectations for Contract Manufacturing and Testing Comprehensive Guide to FDA Data Integrity Expectations for Contract Manufacturing and Testing Pharmaceutical and biopharmaceutical companies increasingly rely on contract manufacturing organizations (CMOs) and contract testing laboratories to support production and analytical services. Alongside this trend, regulatory agencies such as the United States Food and Drug...

ICH Q7 for APIs: A Step-by-Step, Inspection-Ready Guide from Starting Materials to Release

digi — Tue, 04 Nov 2025 20:13:23 +0000

ICH Q7 for APIs: A Step-by-Step, Inspection-Ready Guide from Starting Materials to Release ICH Q7 for APIs — Step-by-Step, Inspection-Ready Guide ICH Q7 defines Good Manufacturing Practice for active pharmaceutical ingredients (APIs) used in human drug products. The guideline covers chemical synthesis, fermentation, recovery, purification, and—where relevant—post-isolation processing steps such as milling and micronization. While...