Australia's TGA Good Clinical Practice (GCP) Inspection Program
Malaysia’s NPRA: Guidance for Bioequivalence Inspection
USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product
USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System
EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information
USFDA Guidances: Preapproval Inspections & Drug Manufacturing Inspections
USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A
SAHPRA Guidance on Pharmacovigilance Inspections for Human Medicinal Product
Voluntary GVP Inspection on Pharma Product Registration Holders- Malaysia’s NPRA
Unannounced Inspections in India And China to be Resumed Soon: USFDA
Malaysia release GUIDANCE on "FOREIGN GMP INSPECTION"- NPRA