Pharma D&S

 

APPROACH to the FUTURE based on EXPERIENCE, INNOVATION and FLEXIBILITY

 

Process & Quality Services - Quality Risk Management

  • Quality Risk Management

 

Since 2008, GMPs (Eudralex Annex 20) envisage the application of Risk Management techniques during the development and production of a pharmaceutical product, in order to avoid exposing patients to risks caused by an inadequate drug safety.

Pharma D&S realizes several QRM projects concerning:

• Production (sterile processes, tablets, liquids, multi-purpose plants/cross contamination, etc.)

• Quality System (trend analysis, frequency of internal and external audits, management change, training, etc.)

• Pharmaceutical development (process parameters, raw material criticalness, packaging material, supplier evaluation etc.)

• Regulatory activities (impact of variations and changes)

• Implementation of a company QRM plan

Pharma D&S supports several API-producing companies in QRM projects.

 

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