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Supplementary Training Modules on Good Manufacturing Practices. Validation. Validation. Part I: Introduction and The Validation Master Plan (VMP) Part 2: Cleaning validation Part 3: Process validation Part 4: QC-related validation Part 5: Review and summary.

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Presentation Transcript
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Validation

Part I: Introduction and

The Validation Master Plan (VMP)

Part 2: Cleaning validation

Part 3: Process validation

Part 4: QC-related validation

Part 5: Review and summary

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Validation

Objectives of Part 1

  • To provide an introduction to the subject of Validation
  • To provide information on the Validation Master Plan
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Validation

Introduction

Three basic principles of Quality Assurance:

  • Quality, safety, effectiveness
  • Cannot inspect quality into a product
  • Processes must be under control
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Validation

WHO validation definition

  • The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.
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Validation

Qualification or validation?

  • A system must be qualified to operate in a validated process
  • Qualify a system and/or equipment
  • Validate a process
  • Qualification versus validation, e.g. you

qualify an autoclave, whereas you validate

a sterilization process

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Validation

Qualification and validation work require:

  • Collaboration of experts
  • Budget
  • Meticulous and careful planning

A Validation Master Plan helps the manufacturer and inspectorate

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Validation

The Validation Master Plan

(VMP)

  • Philosophy
  • Content
  • Strategy
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Validation

Validation Master Plan

  • Recommendation only
  • Cover manufacturer’s validation policy and needs
  • Provides information on validation organization
  • It should describe:
    • why?
    • what?
    • where?
  • by whom?
  • how?
  • when?
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Validation

Validation Master Plan

  • Prospective validation
  • Concurrent validation
  • Retrospective validation
  • Revalidation
  • Change control
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Validation

The VMP helps:

  • Management
  • Validation team members
  • Project leaders
  • GMP inspectors
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Validation

The VMP

  • Identifies validation items (products, processes, systems)
  • Definesnature and extent of testing expected
  • Outlines test procedures and protocols
  • Summary document
  • Management agreement
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Validation

Validation Activities in VMP

  • Every validation activity included
  • Revalidation
  • Validation of new process cycles
  • Large validation projects have separate VMPs
  • Include reasonableunexpected events
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Validation

The VMP:

  • Enables overview of entire validation project
  • Lists items to be validated with the planning schedule as its heart
  • Is like a map
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Validation

The “Introduction” to the VMP

  • Validation policy
  • Project scope
  • Location and timing (including priorities)
  • Validation procedures
  • Standards
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Validation

VMP should state who is responsible for:

  • Preparing the VMP
  • The protocols and SOPs
  • Validation work
  • Report and document preparation and control
  • Approval/authorisation of validation protocols and reports in all stages of validation process
  • Tracking system
  • Training needs in support of validation
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Validation

VMP should contain:

  • Cross references to documents
  • Specific process considerations
  • Specific characteristicsbriefly outlined
  • Validation list (What to validate)
    • premises, systems and equipment
    • processes
    • products
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Validation

VMP should contain:

  • Descriptions of
    • plant (where to validate)
    • processes
    • products
  • Personnel attributes
    • expertise and training
  • Key acceptance criteria
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Validation

VMP should contain:

  • Format for protocols and other documentation
  • List of relevant SOPs (How)
  • Planning and scheduling (When)
  • Location (Where)
  • Estimate of staffing requirements (Who)
  • A time plan of the project (When)
  • Annexes
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Validation

VMP should contain change control

  • Policy and procedure
  • Risk assessment
  • Authorization
  • Failure to properly document changes to the system means invalidation of the process
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Validation

Changes that require revalidation

  • Software changes;Controllers
  • Site changes; Operational changes
  • Change of source of material
  • Change in the process
  • Significant equipment change
  • Production area changes
  • Support system changes
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Validation

In summary, a VMP should contain at

least:

  • Validation policy
  • Organizational structure
  • Summary of facilities, systems, equipment, processes to be validated
  • Documentation format for protocols and reports
  • Planning and scheduling
  • Change control
  • Training requirements
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