cGxP

Consulting

 

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5: Lab/Manufacturing Validation/Qualification Services
 

cGxP can do it alone and interface within your organization
Special Focus on Qualification and Validation
Processes
Test Method and Analytical Method Validation
Cleaning
GHTF/USP/ICH/ ANSI/ ISO
2001 Guidance for Bioanalytical Method Validation

 

Test Method, Product or Process Validation(s) are critical steps necessary to assure that a product will be safe and effective under the actual conditions of use.  Lack of appropriate Validation is the major source of regulatory actions Worldwide. cGxP can assist in validation or re-validation. Our validation services include: 1) Design Review/ Project Coordination; 2) Master Plan; 3) Protocol Development; 4) Field Execution; and 5) Reports and Certification. Further we excel in integration of risk assessment into the validation or verification decision making process.

 

 

healthcare

medical devise

laboratory

   cGxP can provide documented systems and infrastructure to meet all regulatory requirements for their facilities and processes. Our validation specialists have extensive experience in validating all types of systems and equipment. cGxP has a wide variety of experience and can assist in any or all of the following elements:
  • Validation Master Plans
  • Process Characterization and Validation (protocols and Reports)
  • Documentation programs
  • Project master plans
  • Protocols (IQ, OQ, PQ, PV)
  • Field execution data sheets
  • Final reports
  • Process equipment qualification
  • Utility systems qualification
  • Cleaning validation
  • Test method validation
  • Computer system validation
  • Facility (Clean Rooms) qualification
  • Change Control System design and implementation.
  • EtO Sterilization 
  • Electronic Assembly (PCB and component assembly) 
  • Commissioning
  • Test and release of Disposable component mold and assembly validation 
  • Filling and Lyophilization 

 

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