Post on 05-Jun-2018
EFFECTIVE VALIDATION
PLANNING IN
A PRODUCTION FACILITY
FONT COLOR, AHAS
By: Justin RooseHead Validation Engineer – Product Quality Assurance (Global Compliance)
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Session Agenda
• Open-forum training session
• What do you want to learn?
• Two-way / Your experiences
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1. Instruction
2. Questions
3. Do it! (Exercises)
3 Keys to Success
• Well-Developed Strategy
• Don’t miss anything
• Proper Resourcing & Support
• Validation is executed
• Communication
• Properly & Efficiently
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“Let’s not let our success
overshadow our how we did it.
We had a good plan, and
diligence against that plan. This
victory wasn’t coincidence…it
was the result of good planning,
hard work, and communication.”
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Skills & Qualities• Leadership
• Communication
• Written, Oral, Presentation
• Project Management
• Organized, Scheduling, Planning,
Coordination
• Subject Matter Expertise
• Collaboration & Teamwork
• Technical Writing
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Validation
Equipment
(incl. Facility & Utilities)
Process
Packaging
Control & Information
Systems Software
Test Methods
Laboratory Equipment
Sanitizing
Cleaning
Types of Validation
Verification(Med Device)
Assess & Identify Activities
• How is each one is impacted?
• What are the Product, Regulatory,
Company requirements?
• Leverage team expertise & peers
• Team buy-in & resources
• How will we prove capable equipment &
effective processes?
• Validation Requirements
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Activities (con’t)
• How to explore & develop
capability?
• Do your homework…understand it!
• Develop plan, schedule & expectations
• Things go wrong…include contingency.
• Master Validation Plan
• Organized summary of requirements
• Written rationale & justification
• Documents risk-based approach
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Timing of Validation Activities
Key Preparation Validation
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Equipment Qual(IQ/OQ/PQ)
Cleaning & Sanitizing Validation
Process & Packaging Validation
Specs, FAT, SAT
Coverage, Cleaning & Sanitizing Trials
Product Specs/Formulae, Instructions, Plant Trials
Full-scale Production
Facility & Utility Qual(IQ/OQ/PQ)
Standards, Specs, SAT
Classroom Discussion
• BEST Validation Projects
• Examples
• Why?
• CHALLENGING Validations
• Examples
• Why?
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Planning Best Practices
• Clear path & expectations
• Team developed & vetted plan
• History, relationships & expertise
• Good communication
• Thorough FAT, SAT, Plant Trials
• Contingency timing
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Development Phase
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• Over half of your validation work is
spent in the “Development” phase,
before you begin drafting a protocol
• The #1 Cause of Deviations is
insufficient development
• Equipment – Debug / FAT / SAT
• Process/Clean/Sanit – Plant Trials
Equipment Qualification
Pre-requisites
• Classroom Exercise
• Facility, Utility & Production Equipment
• (Critical, SISPPQ)
• What activities & documents are
required to perform a qualification?
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Qualification Development• Approved Specification
• URS, FRS, Scope, Functions, MOCs, Controls
• Timing, Plan & Resources Identified
• FAT Executed / Report
• Materials for SAT/OQ
• Vendor Documentation
• Manual(s), MOCs, Spare Parts, Drawing, Preventive
Maintenance info, I/Os, Calibration info, etc
• Align SAT, Routed & Approved (team)
• Facility Readiness
• Permits, install personnel, install equipment15
Qualification Pre-requisites
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• Quality Standards Approved
• Utilities are Installed (Water, Elec, Comp Air, etc)
• Equipment Delivery
• Equipment Installation
• Auxiliary Eqp, Calibration
• Safety Checklist
• Equipment Functional & “De-bugged”
• IOPQ Drafted, Approved
• Test Plan, Acceptance Crit
• Approved SOPs, Training
• Approved Drawings
Cleaning & Sanitizing
Validation Pre-requisites
• Teams – 3 minutes
• Discuss & Present top 3
• What activities & documents are
required to perform Cleaning &
Sanitizing Validation?
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Definitions
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• Cleaning Validation – Docu-
mented evidence that cleaning
process removes product and
cleanser to acceptable limits.
• Sanitizing Validation – Documented
evidence that sanitizing process reduces
microbes to acceptable limits
Cleaning Validation Development
• Proposed Product Families & Cleanser(s)
• Cleanliness Standards
• MACO, cleanser carryover, visual standard
• Swab Qualification & Analyte Swab Lab Method
• Worst-case locations Identified
• Draft cleaning process & SOP
• Qualified Equipment
• CIP/Coverage Tests
• Cleaning Trial Protocol(s)
• Team collaborated, approved
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Cleaning Validation Pre-requisites
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• Product for testing
• Successful Cleaning Trial(s)
• Approved Product Families
• Qualified Cleansers (Released)
• Approved Cleaning SOPs
• Trained Staff
• Cleaning Validation Protocol
• Test Plan, Acceptance Crit
• Timing, Resources Identified
Sanitizing Validation Development
• Proposed Sanitizer(s)
• Microbial Standards
• Coliform/Obj.Org./Yeast&Mold
• Micro Swab Qualification
• Micro Recovery Lab Method
• Worst-case locations Identified
• Draft sanitizing process/SOP
• Clean Equipment (CV)
• Sanitizing Trial Protocol(s)
• Team collaborated, approved
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Sanitizing Validation Pre-requisites
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• Successful Sanitizing Trial(s)
• Qualified Sanitizer(s)
• Log-reduction, Obj. Organisms
• Released Chemicals
• Approved Sanitizing SOPs
• Trained Staff
• Sanitizing Val Protocol
• Test Plan, Acceptance Criteria
• Timing, Resources Identified
Process & Packaging
Validation
Pre-requisites
• Teams – 3 minutes
• Discuss & Present top 3
• What activities & documents are
required to perform Process Validation
(& Packaging)?
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Definitions
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• Process Validation – Documented
evidence (scientific evidence) the
chemical characteristics of the
formula during the production
process consistently meets quality
requirements (strength, potency, purity, safety)
• Packaging Validation – Evidence…the physical
aspects of the product…meets quality
requirements (safety, identity, quality)
Validation Development
• Salable Goods!
• Qualified Equipment, Facility, Utilities
• Clean & Sanitized Equipment
• All Manufacturing SOPs – Approved & Trained
• Logs & In-process Tests – In Place & Effective
• Proposed Product Families
• Analyte Lab Method
• Draft documents
• Formula, Product Spec, Raw Spec, Instructions
• Component Specifications, Instructions
• Plant Trial Protocol(s)
• Team collaborated, approved
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Process Validation Pre-requisites
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• Successful Plant Trial(s)
• Approved Product Documentation
• Formula(e), Raw & Product Specs,
Manufacturing Instructions
• Standards (Product, Quality)
• Trained Staff
• Approved & Released Raw Materials
• Process Validation Protocol
• Test Plan, Acceptance Criteria
• Timing & Resources Identified
Packaging Validation Pre-requisites
• Successful Plant Trial(s)
• Approved Product Documentation
• Component Specifications, Packaging Instructions
• Standards (Product, Quality)
• Approved & Released Components & Bulk Product
• Packaging Validation Protocol
• Test Plan, Acceptance Criteria
• Timing & Resources Identified. And…trained staff.
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Considerations – Planning
• Make requirements clear early in a project
• Use of Project Management Tools
• Propose Schedule, Resource Plan,
Communication Plan, Critical Path
• Identify & notify departments needed for
support, for each validation phase:
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Develop Draft Execute Deviation Report
Planning Considerations (con’t)
• Support needed…all aspects of execution?
• Who – Draft, Train, sample, test
• Ensure Availability & transfer of knowledge
• What are the requirements?
• Criteria, Sampling, Testing, Results
• When – Our schedule…
• Where – Per the defined plan
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Scheduling Resources
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• Establish R&R
• RACI charts, procedures
• Identify departments needed for support
• Plant, Engr, R&D, QA, QC/Lab, Planning
• Work with departmental management to
ensure allocation of resources
Examples of Management Tools
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Appropriate for the volume of work…
• Project – 4 Levels
1. Individual Level – Checklists
2. Detail Level – Gantt Chart
3. Team Level – 2 Month Forecast
4. High Level – Monthly, by type (ie Eqp)
Management Tool Examples
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An Established Plant
Nashville Plant Validation Tracking
Type Description Date Status / Comments Owner PhaseIOPQ New Transfer Pump April Spec Issued B Marley 1 Plan
IOPQA Motor drive upgrade 13-Apr Drafting, CC approved A Rose 2 DraftIOPQ Filler #4 Done Executed Protocol Review J Lennon 5 Report
CV New Transfer Piping June Getting quotes S Davis Jr 1 Plan
SV New Sanitizer - Pumps 15-Mar Protocol & comm issued G Brooks 3 ExecuteSV New Sanitizer - Fillers June Cleaning Trial May 15 R Starr 1 PlanPV New product X Late May Product ships NLT Apr 15 S Dogg 3 ExecutePV Upcoming Product August Feasibility D Parton 1 Plan
Communication Tips
• Clearly identify activities & responsibility
• Requirements, Action Items, or Expectations
• Status & Progress (management)
• Help people understand “why”
• Training, training…training!
• Communication ensures priority
• Be clear who does what, when.
• Engage affected groups earlier
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Training Tips
• “Here’s what matters to you”
• Make it simple
• Be clear who does what, when.
• Protocol/Test training within 24hr
• Include all those involved
• Assume they didn’t read the protocol
• Visually demonstrate: what, where, how
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Sample Communication Tools
Sampling EmailTo: QA, Manufacturing
Cc: Project Manager
Subject: Upcoming Cleaning Validation: *Title*
In case of a failure/issue/questions, stop immediately and call Who
Execution
When: Target to run late 1st/early 2nd shift
What to Sample: Active Ingredient Swabs (5), Rinse (3),
Sampler: Who?
The protocol & sample supplies are located where. Who delivers samples Where,
and communicate samples are delivered via email/phone to whom
Testing
When: Should be dropped off 2nd shift
What to Test: Active Ingredient X (5), pH Rinse (3),
Communicates results to Who
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Sample Communication Tools
Sampling Instructions (print & deliver with samples)Product Name: _________________ Protocol #: __________________
Validation Contact: ______________ Target Run Date: __________________
Location # of Samples Qty Required Testing (Lab)
Top 1 - N 3 sample jars 500mL Active #1, Active #2, Viscosity
Top 2 - S 3 sample jars 500mL Active #1, Active #2, Viscosity
Bottom 1 - N 3 sample jars 500mL Active #1, Active #2, Viscosity
Bottom 2 - S 3 sample jars 500mL Active #1, Active #2, Viscosity
Transfer - 1 2 sample jars 300mL Active #1, Active #2
Transfer - 2 2 sample jars 300mL Active #1, Active #2
Transfer - 3 2 sample jars 300mL Active #1, Active #2
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Execution Tips
• Try not to schedule too many concurrent
validation activities
• What’s the #1 cause of deviation?
• Ensure processes are well-developed
• Process/Cleaning/Sanitizing
• Be clear who is responsible for what
• Training & Communication
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3 Keys to Success
• Well-Developed Strategy
• Don’t miss anything
• Proper Resourcing & Support
• Validation is executed
• Communication
• Properly & Efficiently
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Group Exercise
• OTC manufacturing plant makes suspension
drug products. The company has decided to
build an expansion for its Blending operation.
• Team 1 - New Equipment:
• Three (3) 6,000L Mix Vessels
• Agitation – Turbine, 0-100rpm
• Team 2 - Daytime Cold & Flu (suspension)
• Acetaminophen 325mg
• Guaifenesin 300mg
• Dextromethorphan HBr 20mg
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Group Exercise
• Validation Requirements?
• What development work is needed?
• High-level schedule:
• Development, Trial, Protocol, Execution
• Resource Plan (who, and when)
• Training & Communication Plan
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Thank you!Justin B. Roose, Head Validation Engineer
Product Quality Assurance, Amway Corp.
7575 Fulton St. East, Ada MI, 49355. Bldg 52-2J
616-787-0031
jroose@amway.com
Biography
Justin is a Lead (Head) Validation Engineer at Nutrilite / Amway Corp in Ada, MI. He & his team
recently completed validation of a 3-phase supplement production facility. His team is
responsible for: equipment & utility qualifications, as well as process, packaging, cleaning,
sanitizing and software validation. He also supports a software validation team responsible for
37 corporate software systems used to govern GMP functions in North American Operations.
Justin received his BS in Chemical Engineering from Calvin College. He has enjoyed over 18
years of experience across the pharmaceutical, vaccine, biologics, foods and nutritional
supplements fields. Since joining Amway Corp in 2006 Justin has created and implemented an
effective change control program, led the Validation Department, and created both software &
process/packaging validation programs.
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