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

Services

CCS Support

ServicesPlant QMSCCS Support

In the pharmaceutical industry, the quality and safety of sterile drugs is vital for companies. With the increasingly stringent global drug regulation, establishing a Contamination Control Strategy (CCS) that covers the entire lifecycle of drugs has become a core component of corporate compliance and quality systems, encompassing all aspects from factory design, material control, process operations to final product release. However, many companies still face multiple challenges in developing a CCS, including inadequate understanding of new regulations, lack of systematic control measures, weak data integration and analysis capabilities, and difficulties in implementing new strategies.

gempex can provide customers with a one-stop CCS solution, encompassing strategy planning, system design, and implementation. We not only assist companies in accurately interpreting domestic and international regulations but also develop tailored practical control strategies based on product processes and company’s actual situation. This helps companies establish a CCS system, pass official inspections, and achieve continuous compliance and optimization of contamination control.

Service Advantage

Experienced expert team
gempex experts cover fields such as regulations, processes, quality control, and validation, with years of practical experience in CCS for sterile drugs.

Up to date with regulatory changes
We continuously track the updates from guidelines from China, the USA, and EU to ensure that strategy design complies with latest international regulatory requirements.

Customized strategy
We develop tailor-made control strategies based on the actual situation of the company, accurately identifying Critical Control Points (CCPs).

Comprehensive one-stop service
We comprehensively cover all stages of CCS from strategy development to operational optimization, reducing customer coordination costs.

Reliability of service
We emphasize project timelines and quality, providing clear project milestones and deliverables.

Continuous optimization mechanism
Establishing a system is not enough. We also support its long-term iteration and improvement.

advantage

Service Scope

We are committed to providing professional support covering the entire CCS cycle for sterile active pharmaceutical ingredients, sterile preparations, and biopharmaceutical manufacturing, including but not limited to:


1. Document design

  • CCS related documents: Elaborate on the overall framework, control measures, monitoring plans, and other aspects of CCS, ensuring the systematisms and operability of the documents.
  • CCS plan development: Based on the individual situation of the company, such as production processes, product characteristics, equipment and facilities, and in combination with regulatory requirements, we develop a comprehensive CCS plan.
  • CCS evaluation matrix: Based on the CCS plan, we develop an evaluation matrix to provide a tool and framework for subsequent risk assessment.
  • Contamination risk assessment: We conduct a comprehensive assessment of potential contamination risks in the production process, identify critical control points (CCPs), and define specific control measures monitoring methods, assignment of responsibilities, and corrective actions for each control point.
  • Validation documents: We assist in completing CCS-related verification based on the evaluation results.


2. Implementation and optimization

  • On-site execution guidance: We assist companies in implementing CCS strategies for the entire production processes, ensuring the effective execution of various control measures.
  • CCS in practice - monitoring and optimization: CCS is considered a “living” document. Thus, we regularly assess and review the application of the CCS system, clearly identify potential issues, define improvement suggestions, and continuously optimize the CCS system.


3. Training and technical support

  • Specialized training: We provide specialized training on CCS, including interpretation of regulations, contamination control knowledge, operational specifications, etc., to enhance employees' awareness of contamination control and operational skills.
  • Technical support: We provide technical support and consulting services during the operation of the CCS system, and answer questions that arise during the practical use of CCS in companies. 

Service Workflow