SERVICES
GMP Auditing & GMP Inspection
Audit & Inspection
Audits provided by KRB GMP team:
• Gap analysis prior to the initiation of an internationalization project
(NMPA/EU/USFDA/TGA/PMDA/WHO/PICS) for drug product & drug substance to fullyidentify the possible gaps against with the target GMP
• Mock audits before the official inspection to challenge the relevant systems, processes and documentation and to strengthen SME present practices
• Third-party audit to support for self-inspection for the purpose of upgrading
• Supplier audit and qualification confirmation
• Pre-audit or periodic audits to the contracted organization for MAH
• Audit to supply chain, warehouses and distributors (GDP)
• Audits to IMP site
• GLP and non-GLP audit for pre-clinical studies
• GCP audit to CROs, centers and other parties
• GCLP and GLP audit to Bioanalytical laboratories
• Pharmacovigilance Audit
Key words：
GMP Auditing & GMP Inspection
Audit & Inspection
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Phone number：400-0123-669
Address：A805, Tower A, Chaowai SOHO, 6B Chaowai Street, Chaoyang District, Beijing 100020
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