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

Services

GMP Upgrade

ServicesGlobal ComplianceGMP Upgrade

Compliance with GMP regulations is vital for companies in the pharmaceutical and medical device industries - inspection findings can result in heavy financial loss, product recalls, and even loss of market access. However, despite having a fundamental quality management framework, many enterprises often suffer from "compliance anxiety" due to issues such as tightening global regulation, rapid regulatory updates, deviations in internal management systems and standards, and inadequate implementation by employees: they are not only worried about passively responding to regulatory risks, but also troubled by the lack of systematic solutions.

gempex specializes in providing enterprises with compliant, efficient and executable GMP upgrade services. We are well-versed in the regulatory systems of the most important markets such as China, US, and EU. From gap analysis to identify possible weaknesses, to modular services such as document optimization, adjustments of rooms, equipment and accessories, and validation support, we ultimately assist companies not only in meeting inspection requirements but also in establishing a robust and internationally compliant quality system. The services are complemented by simulated inspections – Mock inspections - and professional follow-up and responses to findings.

Service Advantage

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

Multinational Compliance System
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 companies 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.We offer tailored GMP compliance plans based on the company’s products, scale stage, and compliance status, ensuring that the services are highly aligned with the customer’s needs.

Full-process coverage
We provide one-stop-services for the entire upgrade process - from early diagnosis to continuous follow-up in the later phase, so that customers do not have to work with various service suppliers, saving communication and time costs.

Combining efficiency with cost
We emphasize on "minimizing compliance disruptions", focusing on key risks and high-value improvements, and assisting companies in achieving a maximal compliance security 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 quality management system and the relevant GMP regulations and provide a clear and feasible roadmap with proposed actions.


2. Regulatory consulting and interpretation

We provide precise and forward-looking regulatory interpretations and applicability guidance for different market-specific regulations such as China, EU and US FDA cGMP, helping companies 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.
  • Documentation management: Optimize various record templates such as batch records, audit records, and any other records and logs, to comprehensively enhance data reliability and traceability.


4. Equipment and facility improvement

We conduct GMP compliance assessments for production workshops, warehouses 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 companies, we provide a series of training courses ranging from high-level awareness to shop-floor operational skills, covering topics such as GMP fundamentals, specific SOP implementation, data integrity, and audit techniques.


6. Qualification & Validation Guidance

We provide comprehensive qualification and validation support for key business processes, covering the following types:

  • Equipment qualification (including risk assessment)
  • Process validation and cleaning validation
  • Computerized system validation (CSV)
  • Analysis method validation
  • Others


7. Mock inspection

Mock inspection process to mimic regulatory agencies inspection processes and to help companies identify weaknesses and pitfalls in advance, to improve inspection preparation strategies, and to enhance responsiveness.

Service Workflow