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GMP Audit Preparation: Why QA Departments Scramble, and How to Build Continuous Inspection Readiness

by Gregory Sivo | May 31, 2026 | General

By Gregory Sivo | Truex Consultancy | Updated May 2026 | 12-minute read GMP audit preparation has a way of turning into a last-minute scramble. This article explains why that happens, what the scramble reveals about the underlying quality system, and how...

GMP Change Control: Requirements, Common Failures, and What Inspectors Actually Find

by Gregory Sivo | May 25, 2026 | General

By Gregory Sivo | Truex Consultancy | Updated May 2026 | 12-minute read Learn what EU GMP and ICH Q10 require from a change control system, why change control programmes fail in practice, and what a compliant, inspection-ready process looks like from the inside. One...

Data Integrity in GMP: What Inspectors Are Actually Looking For in 2026

by Gregory Sivo | May 4, 2026 | General

Why Data Integrity Is the Dominant GMP Finding of 2026 If you are preparing for a regulatory inspection in 2026, there is one area above all others where preparation must be demonstrably robust: data integrity. Between 2016 and 2023, the FDA issued 1,766 Warning...

Recent Posts

  • GMP Audit Preparation: Why QA Departments Scramble, and How to Build Continuous Inspection Readiness
  • GMP Change Control: Requirements, Common Failures, and What Inspectors Actually Find
  • GMP Management Review: Requirements, Common Failures, and What Inspectors Find
  • GMP Continuous Improvement: A Practical Framework for Pharmaceutical and Life Sciences Manufacturers
  • Data Integrity in GMP: What Inspectors Are Actually Looking For in 2026

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