Good Manufacturing Practice

About Good Manufacturing Practice (GMP)


biocontainment

CCTech believe in providing an efficient and cost effective approach to the validation of new facilities.

To achieve this we use leveraging of the commissioning results into the qualification protocols. This requires:

  • Review and pre-approval of the commissioning protocols.
  • Selection of competent sub-contractors and commissioning teams.
  • Effective management.

Failure mode and effects analysis (FMEA)

The Regulatory Authorities expect that risks are assessed and mitigating actions implemented. FMEA provides the ideal tool to fulfil this requirement.

CCTech build the FMEA process into the Design Qualification stage of the project to identify design risks. These are then reassessed on completion of the Installation and Operational Qualification, to verify that any risks which were deemed to be a “Medium or High” risk have been satisfactorily addressed.

We work on projects which handle therapies derived from pluripotent stem cells, mesenchymal stem cells, other somatic cell therapies, immune therapies (including gene modified therapies) and tissue engineered products.

  • Contained and non-enclosed manufacturing processes
  • Segregation of materials, processes and people
  • Maximum flexibility to facilitate many process types
  • Autologous and Allogeneic Products

Biomedical & Precision

To ensure success these laboratories need to be designed and project managed by those who understand the needs and requirements.

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Biocontainment

CCTech provides key services in delivering new biocontainment research laboratories.

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