essential elements for a successful validation master plan ... · essential elements for a...

Essential Elements

for a

Successful Validation Master Plan and Program

Connie Hetzler

October 2015

Validation Planning Process

Why do we need a “Road Map” ?

Validation Planning Process

What are Industry Expectations?

While a VMP is not a specific FDA requirement,

is often a best practice !

Very beneficial to organize a validation with a central

document.

GHTF – Process Validation Guidance January 2004

Pages 8,13 : “Create a Master Validation Plan”

Validation Planning Process

Who benefits from Validation Planning?

Project Leader & Team Management Auditors

Validation Planning Process

Site Validation Master Plan

OR

Product Line/Project Validation Master Plan

Validation Planning ProcessSite Validation Master Plan

Describes general validation approach for the site

Roles and Responsibilities

References procedures that are followed

How risk model is applied to Validation

Can include flow chart summarizing validation

documentation hierarchy

Includes table or index summarizing completed

and planned validations

Concise document illustrating an organized

approach and understanding of industry

requirements

Validation Planning ProcessSite Validation Master Plan

ExamplesValidation

Scope

VMP or VP

Reference

Validation

Report

Date

Re-Validation

Assessment Date

Production Line 1

Blood Collection Device

VMP-2801 09/04/13 09/04/15

Production Line 2

Blood Collection Device

VMP-2801 12/15/14 09/04/15

Production Line 3

Blood Collection Device

VMP-2801 02/09/15 09/04/15

Production Line 1

Lancet Mechanical Assembly

VMP-2901 08/17/11 08/17/13

Facilities and Utilities Production Areas VMP-2802 08/01/13 08/01/15

Facilities and Utilities Assembly Area VMP-2802 08/01/13 08/01/15

Cleaning Validations VMP-3001 07/13/14 09/04/15

Analytical Test Method Validations VMP-3101 07/02/13 09/04/15

Enterprise Wide Software Validations VMP-3201 05/12/13 05/12/16

Validation Planning ProcessSite Validation Master Plan

Examples

Table of Contents Page

Purpose 5

Document Scope 5

References 5

Responsibilities 6

Site and Process Description 7

Products Manufactured 8

Validation Methodology 9

Critical to Quality Equipment, Processes, Systems 10

Validated Processes 11

Re-Validation Assessments 12

Project Schedule 13

Validation Planning ProcessSite Validation Master Plan

Documentation Hierarchy Example

Validation Planning ProcessSite Validation Master Plan

Criticality/Risk Example

Category 1: Equipment, methods, systems or processes

considered critical to quality will be validated

prospectively.

Category 2: Equipment, methods, systems or processes

not considered critical to quality, are 100% verified or

require only calibration are not validated.

Validation Planning ProcessProduct Line/Project Validation Master Plan

Describes validation approach for the Product Line

Product Functional Description and Process Flow

Diagrams (unit operations)

How risk model is applied to Validation

Measurement Systems Analysis and Treatment of Data

Validation Index indicating required validations

Special Environmental Controls

Still high level, but more detailed document

illustrating an organized approach and

understanding of how to apply industry

guidelines to a specific product situation.

Validation Planning Process

Index Example

Unit Operation Description and

Number

IQ OQ PQ

Film Unwind and Cut x x x

Heat Sealer Module x x x

Rotary Table Based Attachment x x x

Adhesive Dispense Unit x x x

Card Transport Conveyor x x x

Integrated Assembly Unit x x x

Validation Planning Process

Index Example

Unit Operation

Description and

Number

IQ pFMEA

Risk

OQ Test

Level

TMV SW PQ

Film Unwind and Cut x Med x Med x x

Heat Sealer Module x High x High x x

Rotary Table Based

Attachment

x Med x Med x x

Adhesive Dispense Unit x High x High x x x

Card Transport

Conveyor

x Low x

Integrated Assembly

Unit

x High x High x

Validation Planning ProcessSite Validation Plan

Supporting Systems

Facilities/Utilities

Measurement Systems

Cleaning Processes

Validation Planning ProcessFacilities/Utilities Validation Master Plan

Example

Risk Assessments need to identify which

facility elements and utilities impact

product manufacture and performance.

Controls and monitoring are important for

facilities/utilities.

Critical Utilities Index IQ OQ PQ SW

Compressed Air Generation and Distribution x x x

Deionized Water Generation and Distribution x x x

Nitrogen Generation and Distribution x x x

Walk-in Cold Rooms x x

Data Quality Triangle [USP<1058>]

Validation Planning ProcessMeasurement Systems Validation Master Plan

Example

OR ICH Q2 (R1)

Test Instrument IQ OQ PQ Calibration

Agilent HPLC 1260 x x x x

Waters LC-MS System x x x x

Toc Analyzer x x x Vendor

Identification Impurity Quant Impurity

Limit

Assay

Content/Potency

Accuracy x x

Repeatability Prec. x x

Intermediate Prec. x x

Specificity x x x x

Detection limit x

Quantitation limit x

Linearity x x

Range x x

Validation Planning Process

References

validation-online.net

thefdagroup.com

ivt.network.com