service contrôle qualité Cebiphar

Quality Control

CEBIPHAR sets up a specific organization to secure your Supply Chain. We perform Quality Control of raw materials, packaging items and finished products

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CEBIPHAR can fit your needs

Our quality control laboratory (QC testing CRO) supports you for the following activity:

  • Control of raw materials and finished products according to the different Pharmacopeias (European Pharmacopeia (EP), United States Pharmacopeia (USP), British Pharmacopeia (BP), Japanese Pharmacopeia (JP), Chinese Pharmacopeia))
  • Equivalence of EP / USP monographs
  • Development and writing of control monograph
  • Method verification and analysis of residual solvents according to CEP / DMF
  • Import, EU re-testing and release of products manufactured outside the European Union (in partnership for import)
  • Qualification of raw material sources: Comparison of batches from different suppliers
  • Counterfeits: batch comparative analysis
  • Product Quality Annual ReviewAnalysis of non-clinical formulations
Business process

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

Development - Validation - Transfer - Verification
Processus métier

Stability
Processus métier

Quality control
Interactions process

Our approach

1

Anticipation

Optimal management of stocks of consumables and reference substances

2

Security

Co-validation strategies between the production site and CEBIPHAR laboratories

3

Partnership

Robust procedure for OOS management

4

On Time Delivery

Frequent and personalized reporting for results delivery

CEBIPHAR teams make every effort to meet the essential needs in a Quality Control partnership: communication and on time delivery

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