Why Choose Reliant FDA Experts?

Validation

The goal of a validation program is to establish a system which provides a high degree of assurance that every step, process, and change has been properly evaluated against predetermined criteria before its implementation. Ultimately, it’s all about making sure the product you manufacture is consistently what you’re intending (and claiming) to produce. This means everything involved in the manufacturing process that could impact the quality of the product needs to validated: the equipment that’s used, the manufacturing process itself, any software involved, how cleaning is performed, and even the analytical methods used to check the quality.

WHO SHOULD DO VALIDATION?

Industry Code of Federal Regulation (CFR) References
Pharmaceutical Method Validation, Equipment/Utility/Facility Qualification, Process Validation, Software Validation, Cleaning Validation
Medical Device Method Validation, Equipment/Utility/Facility Qualification, Process Validation, Software Validation, Cleaning Validation
Biologics Method Validation, Equipment/Utility/Facility Qualification, Process Validation, Software Validation, Cleaning Validation
Dietary Supplements None
Human and Pet Food None
Cosmetics None

COMPONENTS OF A VALIDATION PROGRAM

  • Prequalification/Prevalidation Documentation
  • Validation Master Plan or SOPs
  • Validation Project Plan
  • Protocols
  • Reports
  • Additional Software Validation Documentation

COMMON ISSUES, MISTAKES AND PITFALLS

  • Not having clearly preapproved specifications
  • Poor or insufficient traceability
  • Missing or inadequate re-qualification
  • Use of vendor protocols without tailoring to meet needs
  • Deviations from defined methodology without justification

EXAMPLES OF THE HELP RELIANT CAN PROVIDE

  • Build a Sustainable Validation Program
  • Audit, Assess, and Provide Recommendations on an Existing Validation Program
  • Generation Validation/Qualification Protocols
  • Execution Validation/Qualification Protocols
  • Generation Validation/Qualification Reports
  • Perform a Validation Status Gap Assessment

ASSOCIATED JOURNAL ARTICLES AND COMPLIANCE TIPS

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