Articles tagged with “process-validation”

FDA First AI cGMP Warning Letter: Manufacturing Lessons

Examine the FDA's first warning letter for AI misuse in cGMP manufacturing. This review details compliance lessons and human oversight requirements for QA.

40 min read

4/23/2026

fda warning letter ai in manufacturing cgmp compliance pharmaceutical quality system process validation quality assurance regulatory compliance

Process Validation for Biotech: A PPQ & CPV Guide

Lifecycle approach to biotech process validation: PPQ and CPV planning, execution, and monitoring under FDA, EMA Annex 1/15, ICH Q9(R1), Q12, and Q13 guidance.

45 min read

1/8/2026

process validation biotechnology ppq cpv quality by design (qbd)fda guidance ema annex 15 gmp manufacturing control strategy

Pharma Tech Transfer: A Guide to the R&D to CDMO Process

Learn the critical steps for successful pharmaceutical technology transfer. This guide covers the R&D to CDMO process, key documents, and how to avoid scale-up

40 min read

1/6/2026

cdmo drug manufacturing scale-up process validation quality agreement ich q10 biopharma outsourcing