In every FDA inspection, whether GCP, GMP, or GLP, the fundamental question is the same: can the organisation prove that what it says happened actually happened, in the way it says it happened, when it says it happened? That question is answered t
EU Directives & Inspection Readiness: Complete Guide
Inspection readiness is not something an organisation builds in the weeks before a regulator arrives. It is the condition the organisation is in every other day of the year. For companies operating in or supplying to the EU market, that condition
How FDA Inspections Enforce Postmarketing Adverse Drug Experience Reporting
A practical guide to understanding how FDA inspections enforce postmarketing reporting rules and protect public health. Table of Contents Introduction Understanding Postmarketing Adverse Drug Experience Reporting FDA’s Autho
Safe Handling Practices During Product Destruction in Regulated Industries (USA)
In regulated industries, like pharmaceuticals, biotech, chemicals, and food, product destruction is a serious task. Whether the product is expired, recalled, contaminated, or simply unsellable, it must be destroyed properly. This keeps workers safe,
How FDA Inspects Computerized Systems Under cGMP: A Legal Overview
LAW: FDA cGMP Compliance How FDA Inspects Computerized Systems Under cGMP: A Legal Overview Computerized systems in pharmaceutical and biotech manufacturing are subject to FDA inspection under 21 CFR Parts 211 and 820, the agency's data integ
Food Safety Violation Identification and Correction Guide
Food safety inspections play a key role in protecting public health. When violations are spotted and fixed, foodborne illness risks go down for everyone. This guide helps health inspectors spot and fix four major issues: employee hygiene, equipment s
Food Establishment Inspection Readiness: Trends and Gaps
Food safety is a top priority for public health, and inspections play a vital role in keeping restaurants, processing plants, and retail vendors safe. In recent years, data shows that most food establishments are well-prepared before their inspection










