service nettoyage Cebiphar

Cleaning validation

As a cleaning validation CRO, CEBIPHAR provides, alongside UPS Consultants, consultancy to define the cleaning validation strategy suitable to your production site.

Customized support

CEBIPHAR can fit your needs

Our cleaning validation services:

Summary of requirements and regulatory framework (Europe and US): human and veterinary medicines and medical devices

Development of validation strategies and project management:

  • Organization of the steering committee and planning
  • Optimization of methods, groupings, worst case
  • Definition of contaminants and determination of relevant tracers
  • Calculation of acceptance criteria

Documentary writing: validation master plan, protocols, final reports

Training of managers and operational teams, qualification of sampling procedures

Development, validation and transfer of cleaning verification methods

Development and validation of sampling techniques and determination of recovery

Samples management and analysis

Business process

Discover the 4 phases of the life cycle of the analytical method

Interactions process

Our approach

1

Flexibility

A study design adapted to the number of sampling media and the specifications set for each media

2

Expertise

Support from UPS Consultants specialist

3

Partnership

Support for the transfer of the analytical method to your production site

4

Agility

Implementation of a checklist to speed up the quotation writing phase and shorten the project start-up time

CEBIPHAR provides you with full support from the development of the analytical method to the training of operators on your manufacturing site

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