• 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 are the lifeblood of enterprises. 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 enterprises still face multiple challenges in advancing CCS, including inadequate understanding of new regulations, lack of systematic control measures, weak data integration and analysis capabilities, and difficulties in implementing strategies.

gempex can provide customers with a one-stop CCS solution, encompassing strategy planning, system construction, and implementation. We not only assist enterprises in accurately interpreting domestic and international regulations, but also tailor practical control strategies based on product processes and enterprise realities. This helps enterprises establish a CCS system, pass official inspections, and achieve continuous compliance and optimization of pollution control.

Service Advantage

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

Precise regulation control
Continuously tracking the latest guidelines from China, the USA, and EU to ensure that strategy design complies with international regulatory requirements.

Customized strategy
Tailor control strategies based on the actual situation of the enterprise, accurately identifying CCPs.

Full-cycle one-stop service
Covering the complete lifecycle of CCS from strategy to operational optimization, reducing customer coordination costs.

Efficient response
Emphasize project timeliness and quality, providing clear project milestones and deliverables.

Continuous optimization mechanism
It not only aids in establishing a system but also supports 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 companies, including but not limited to:


1. Document system construction

  • CCS program documents: Elaborate on the overall framework, control measures, monitoring plans, and other aspects of CCS, ensuring the systematicness and operability of the documents.
  • CCS plan development: Based on the actual conditions of the enterprise, such as production processes, product characteristics, equipment and facilities, and in combination with regulatory requirements, develop a comprehensive CCS plan.
  • CCS evaluation matrix: Based on the CCS plan, construct an evaluation matrix to provide a tool and framework for subsequent risk assessment.
  • Pollution risk assessment: Conduct a comprehensive assessment of potential pollution risks in the production process, identify critical control points (CCPs), and clarify specific control measures, monitoring methods, division of responsibilities, and corrective actions for each control point.
  • Validation documents: Assist in completing CCS-related verification based on the evaluation results.


2. Implementation and optimization

  • On-site execution guidance: Assist enterprises in implementing CCS strategies into their actual production processes, ensuring the effective execution of various control measures.
  • CCS operating monitoring and optimization: Regularly assess and review the operating of the CCS system, promptly identify potential issues, propose improvement suggestions, and continuously optimize the CCS system.


3. Training and technical support

  • Specialized training: Provide specialized training on CCS, including interpretation of regulations, pollution control knowledge, operational specifications, etc., to enhance employees' awareness of pollution control and operational skills.
  • Technical support: Provide technical support and consulting services during the operation of the CCS system, and answer questions encountered by enterprises in practical operations.

Service Workflow