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