• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Services

Inspection Support

ServicesGlobal ComplianceInspection Support

As the global pharmaceutical market continues to integrate, drug and medical device manufacturers are subject to inspections by GMP authorities from different countries. Whether foreign companies entering the Chinese market or domestic companies expanding internationally, all face significant challenges in responding to on-site inspections within unfamiliar regulatory systems. Companies often lack adequate preparation due to unfamiliarity with target market regulations, regulatory and cultural differences, language barriers, inspection processes, and inexperience—leading to inspection failures and even impacting product launch timelines and corporate reputation.

gempex leverages the global expertise (covering China, the U.S., and Europe) and professional regulatory knowledge to provide precise support for domestic and foreign official inspections. We have a deep understanding of the regulatory differences and key focus areas across major markets, enabling us to help companies quickly identify gaps and develop effective response strategies. Our services not only enhance inspection readiness through customized training and mock inspections but also provide on-site interpretation and emergency support during inspections to ensure smooth communication and appropriate responses. Until now, we have successfully guided numerous companies pass the GMP inspections by official authorities such as NMPA, FDA, and EMA, supporting their products’ entry into target markets.

Service Advantage

International Team: Experts with backgrounds in China, Europe, and the U.S., capable of accurately interpreting and translating requirements across different regulatory systems;

Customized Services: Offer prioritized service packages ranging from "rapid assessment" to "in-depth correction" based on inspection urgency and client readiness, meeting individualized needs;

Extensive Practical Experience: Over 20 years of GMP service experience, including direct participation with clients in various official inspections;

Efficient Implementation: Provide risk-based and resource-appropriate response strategies, avoiding unnecessary large-scale corrections and focusing on key regulatory priorities to achieve maximum readiness within limited time;

End-to-End Support: Deliver hands-on guidance throughout the entire process—from training and mock inspections to corrective action tracking and deficiency response—ensuring thorough preparation.

advantage

GMP Inspection Support Service

Our end-to-end support covers the entire process from preparation and simulation to inspection support, covering bidirectional needs (foreign companies facing Chinese inspections and domestic companies facing international inspections). Specific services include:


1. Customized Training, including but not limited to:

  • GMP Overview:GMP introduction, regulatory systems, etc.;
  • Regulatory and Cultural Differences:Overview of target market official authorities, market access processes, key GMP differences (including product-specific requirements), official inspection processes and checklists, cross-cultural communication considerations, and focus points from product development to market launch;
  • Facility and Equipment:Basic GMP layout and zoning concepts, analysis of personnel, material, and waste flows, design review and compliance strategies for utility systems (water, gas, HVAC), pressure differentials, etc.;
  • Quality Management System:Comprehensive coverage of change management, deviation handling, complaint management, risk management, training systems, gowning procedures and related training confirmation, contamination control, environmental monitoring, qualification and validation, data integrity, and other full-process topics.


2. Gap Analysis and Mock Inspections: Conduct systematic GMP gap analysis and perform on-site mock inspections focusing on key inspection points, providing detailed reports and corrective action recommendations.


3. Comprehensive Inspection Preparation: Assist in developing inspection agendas, planning inspection routes, preparing presentation slides, and compiling documentation checklists (including the bilingualversions).


4. On-site inspection support: Provides on-site or remote support, including inspection route guidance, translation, preparation of post-inspection materials, submission of pre-inspection materials, real-time problem response guidance, and serving as a communication bridge.


5. Response Support for Findings: Assist companies in accurately understanding inspection findings and guide the preparation of responses.

Service Workflow