Inspection
Anatomy of an FDA Inspection | Part 2 of 2
Winning the Inspection Game – The Habits of Inspection-Ready Companies LIVE THE CULTURE: The entire organization, from top management to line operators, knows that quality isn’t a department—it’s a mindset. It’s part of the air you breathe, the decisions you make. Follow SOPs consistently, encourage employees to report and fix ... Read More
Anatomy of an FDA Inspection | Part 1 of 2
Inspections are how the FDA checks that what’s promised is real: FDA inspections can occur for various reasons – a routine schedule, a follow-up to a prior issue, a pre-approval for a new product, or “for-cause” in response to a specific problem. What Happens During an FDA Inspection? (And What ... Read More
US FDA Inspection and SMEs Role
Before Inspection During Inspection Key Phrases Best Practices Common FDA Inspection Questions After Inspection Additional Tips By following these guidelines, SMEs can effectively communicate with US FDA inspectors. Read also: Resource Person: Rajesh Jain
Audits and Inspections in Pharmaceutical Industries | Similarities and Differences
Audit: ensure quality and compliance with systematic, independent examination and documented process Inspection: determination of conformity to specified requirements “Audit” can be seen as an umbrella term, whereas “inspection” is one concrete type of audit. Similarities 1) Both involve a review of processes, procedures, and records.2) Both aim to determine ... Read More
Common Terms Used in USFDA Inspections
Types of USFDA Inspections The agency also conducts inspections to verify the reliability, integrity and compliance of r&d facilities, testing labs, cmo, clinical and non-clinical research being reviewed in support of pending applications. FDA Forms 482, 483 and 484 Establishment Inspection Report (EIR) A comprehensive report that provides a detailed ... Read More
Criteria of Maintaining Audit and Inspection Readiness in Pharmaceutical Industry
To maintain audit and inspection readiness at all times in pharmaceutical industry, following criteria are to be maintained: 1. Clear Communication Channel 2. Document Control and Management 3. Effective Training and Competency Programs 4. Robust Change Control Processes 5. Real-time Monitoring and Data Analytics 6. A Culture of Continuous Improvement ... Read More
FDA Findings and Remedies on cGMP Violations
The U.S. Food and Drug Administration (FDA) recently inspected a US drug manufacturing facility and identified several significant cGMP violations, resulting in a Warning Letter (#649198). The violations include: Here are five remediation actions that the company should take: Cleaning and Maintenance Procedures: Investigations and Deviations: Production and Process Control ... Read More