Process Validation

Product & Process Division

Validation meets the international regulatory compliance requirements

DOC performs validation for new or already existing processes, in case of process improvements or changes to introduce into your manufacturing area. Our study approach is designed in order to meet the international regulatory compliance requirements for process validation. Each process validation will vary in its scope, based on the reason for the validation, criticality and complexity of the process and associated equipment.

 

Mainly focused on pharmaceutical and cosmetic liquid applications, in this area DOC is able to offer the following Validation Services:

  • In process qualification studies for:
    • Tubing
    • Connection
    • Process equipment or material in contact with the pharmaceutical formulation
  • Single Use System Validation
  • Process Optimization Study
    • Screening
    • Filterability
    • Scale-up studies
  • Product and Process Filter Validation
    • Compatibility Studies
    • Extractables and Leachables Studies
    • Adsorption Studies
    • Viability Studies (using reference standard and bioburden isolate microorganisms)
    • Bacterial Retention Studies (using reference standard and bioburden isolate microorganisms)
  • Toxicological Evaluation and Assessment
  • Cleaning Validation
    • Validation Master Plan
    • Risk Assessment
    • S.O.P. Development and Review
    • Cleaning Validation Protocols and Reports
    • Grouping & Bracketing Approach
    • Toxicological Assessment (PDE)
  • Sanitizing Efficacy Validation (in vivo and in vitro testing) on
    • Stainless Steel
    • PVC
    • Plastic Laminate
    • Glass
    • Plexiglass
    • Manufacturing Surface Material
  • Analytical Method Development, Validation and Transfer under cGMP Compliance
  • Particle Release Testing
  • Endotoxin Retention Studies

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