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

Services

GMP Upgrade

ServicesGlobal ComplianceGMP Upgrade

GMP compliance is the "lifeline" for enterprise survival in the pharmaceutical and medical device industry - a inspection defect may lead to heavy fines, product recalls, and even loss of market access qualifications. However, despite having a basic quality management framework, many enterprises often suffer from "compliance anxiety" due to issues such as tightening global regulation, rapid updates of regulations, deviations in internal management systems and standards, and inadequate employee implementation: they are both concerned about passively responding to regulatory risks and struggling with the lack of systematic solutions.

gempex specializes in providing enterprises with compliant, efficient and executableGMP upgrade compliance. We are well-versed in the regulatory logic of mainstream markets such as China, US, and EU. From gap analysis to identify risk points, to modular services such as document optimization, hardware upgrade, and validation guidance, we ultimately assist enterprises not only in meeting inspection requirements but also in establishing a robust and internationally compatible quality system through simulated inspections and defect closed-loop support.

Service Advantage

Professional team: All team possess profound knowledge of regulations and extensive practical experience. Some members have participated in the formulation of industry regulations or served as review experts for regulatory agencies, enabling them to provide the most cutting-edge and professional compliance guidance.

Global compliance integration capability: The team comprises regulatory experts from multiple regions including China, US and EU, capable of simultaneously meeting GMP requirements in China, US, EU and other regions. It assists enterprises in establishing a unified and compatible quality management system, supporting market access both domestically and internationally.

Customized services: We tailor GMP compliance improvement plans based on the enterprise's products, scale stage, and compliance status, ensuring that the services are highly aligned with the enterprise's needs.

Full-process coverage: We provide one-stop full-process services from early diagnosis to continuous tracking in the later stage, eliminating the need for enterprises to interface with multiple suppliers and saving communication and time costs.

Efficient implementation: Emphasizing "minimizing compliance disruptions", focusing on key risks and high-value improvements, and assisting enterprises in achieving maximum compliance benefits with minimal investment.

advantage

Service Scope

We provide comprehensive and multi-level GMP upgrade services, covering the following key areas:


1. Gap analysis

Through systematic on-site audits and document reviews, we accurately identify the gaps between the existing system of the enterprise and the target GMP regulations, and provide a clear and feasible roadmap for rectification.


2. Regulatory consulting and interpretation

We provide precise and forward-looking regulatory interpretations and applicability guidance for different market regulations such as China, EU and US FDA cGMP, helping enterprises avoid compliance risks caused by misunderstandings.


3. Quality system Optimization


  • Standard Operating Procedure (SOP): Develop or optimize the SOP system for core processes such as production, quality, and equipment to ensure compliance, clarity, and executability of operations.
  • Record management: Optimize various record templates such as batch records, inspection records, and logs, to comprehensively enhance data reliability and traceability.



4. Hardware improvement

Conduct GMP compliance assessments for production workshops, warehousing and logistics facilities, and other relevant areas. Propose targeted improvement plans covering aspects such as layout, clean environment, equipment management, and labeling.


5. Customized training

Based on the actual needs of enterprises, we provide a series of training courses ranging from high-level awareness promotion to frontline operational skills, covering topics such as GMP fundamentals, specific SOP implementation, data integrity, and audit techniques.


6. Qualification & Validation Guidance

We provide comprehensive verification support for key business processes, covering the following types:


  • Equipment validation (including risk assessment)
  • Process validation and cleaning validation
  • Computerized system validation (CSV)
  • Analysis method validation/qualification
  • Others: such as temperature distribution validation



7. Mock inspection

Mock inspection process of regulatory agencies to help enterprises identify risk points in advance, improve inspection preparation strategies, and enhance confidence in response.