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Validation

Supplementary Training Modules on Good Manufacturing Practices

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Part I: Introduction and The Validation Master Plan

(VMP)Part 2: Cleaning validationPart 3: Process validationPart 4: QC-related validationPart 5: Review and summary

Validation

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Objectives of Part 1 To provide an introduction to the subject

of Validation To provide information on the Validation

Master Plan

Validation

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Validation

IntroductionThree 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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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

Validation

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Qualification and validation work require:

Collaboration of experts

Budget

Meticulous and careful planning

A Validation

Master Plan helps

the manufactur

er and inspectorat

e

Validation

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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) Defines nature and extent of testing

expected Outlines test procedures and protocols Summary document Management agreement

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Validation Activities in VMP Every validation activity included Revalidation Validation of new process cycles Large validation projects have separate VMPs Include reasonable unexpected events

Validation

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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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ValidationVMP 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 characteristics briefly outlined Validation list (What to validate)

premises, systems and equipment processes products

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ValidationVMP should contain: Descriptions of

plant (where to validate) processes products

Personnel attributes expertise and training

Key acceptance criteria

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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

Validation

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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 atleast: 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