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Gilead, Pfizer and GSK Warn on AI; Fix GMP Workflows Before Scaling

Senior quality leaders from Gilead Sciences, Pfizer and GSK used the Bioprocessing Summit in Boston to caution pharmaceutical companies against rushing weak processes into digital and AI systems. Their message was consistent: digital technology can improve quality operations, but poorly
  • News
Gilead, Pfizer and GSK Warn on AI; Fix GMP Workflows Before Scaling

AstraZeneca–BMS $400B Merger Talks; Could GxP Integration Trigger a Quality Crisis?

AstraZeneca and Bristol Myers Squibb have reportedly discussed a potential combination that could value the new group at nearly $400 billion. The talks remain preliminary, and neither company has announced a transaction. However, its scale and overlapping oncology portfolios matter
  • News
AstraZeneca–BMS $400B Merger Talks; Could GxP Integration Trigger a Quality Crisis?

FDA Proposes One Registration: Can Quality Systems Control Every Manufacturing Unit?

The FDA proposed a new registration pathway on July 10, 2026, for distributed manufacturing networks that operate through a hub-and-spoke model. If finalized, the FDA distributed manufacturing rule would let qualifying networks register as one establishment instead of registering every
  • News
FDA Proposes One Registration: Can Quality Systems Control Every Manufacturing Unit?

CSV Documentation in 2026: GMP Compliance, Data Integrity, and Inspection Readiness

This article explains how CSV Documentation supports GMP compliance in computerized systems, focusing on validation traceability, IQ OQ PQ documentation, and data integrity requirements aligned with FDA 21 CFR Part 11 and EU Annex 11 expectations.
  • Blog, Validation and Qualification
Pharmaceutical validation documentation workflow for Computer System Validation (CSV) in GMP computerized systems, highlighting validation traceability matrix, IQ OQ PQ documentation, and compliance with GAMP 5 validation and data integrity standards.

GMP regulations in 2026: FDA EU Inspection Checklist Guide

This article provides a practical overview of GMP regulations in 2026, covering FDA 21 CFR 210/211, EU GMP guidelines EudraLex Volume 4, and WHO expectations. It explains inspection trends, audit readiness, and regulatory compliance gaps in pharmaceutical manufacturing systems.
  • Blog, Quality Management System
GMP regulations checklist pharma visual illustrating EU GMP guidelines EudraLex Volume 4, FDA 21 CFR 210 211 compliance guide, and data integrity requirements GMP inspections in pharmaceutical manufacturing environment.