Inspection
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 Remdies 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