ABB

Application of the
C&Q Baseline Guide
to Streamlining
Validation
Lynn Edwards
Principal Consultant
Covered today
n Guidance from Baseline Guide
n Good Engineering Practice
n Relevant experience old and new system
n Validation of both systems
n What went well and not so well
n Comments on the baseline guide
n Learning points.
The View from the FDA
n Back to Basics
n Protect Public Health
n Risk Based Approach (from baseline C & Q guide)
n Underpinned by validation
n End user accountability
Risk
Assessment
CGMPs
Validation
Security
systems
Documentation
Baseline
Guides
GAMP PIC/S
The C & Q Guide Overview
Three Key Concepts
n Impact assessment (IA)
n Good Engineering Practice (GEP)
n Qualification Practices
Four Philosophies
n GEP critical to success of approach
n Baseline approach restricts qualification to Direct Impact
systems
n If Direct Impact then GEP + Qualification
n GEP only for Indirect Impact systems.
Impact Assessment
n Impact is used at system level
n Critical is used at component level
n Only direct impact systems have critical components
n As with anything you could have an exception if you want to!
n Support with rationales. Components
Critical Non-Critical
Direct
Impact
Indirect
Impact
D
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Systems
GEP only!
GEP + Qualification Practices
Good Engineering Practice
n Competent project management
n Competent engineering design, procurement,
construction and commissioning
n Operation and maintenance requirements understood
n Work to industry standards
n Fully documented.
Qualification Practices
Process
Validation
Scope of Guide
Engineering Change Control
QA Change Control
GEP Contribution
Of Interest to the Regulator
IQ & OQ
Commissioning
Impact Assessment
Enhanced Design
Review
Design Development
PQ
Design for Impact
A thought
n 80% Project Deliverables involve the supplier
n Why would you not work with them?
n What is the cost of validation to your product?.
User Requirement
(i.e..What)
Functional Design
(i.e. How as Schematic)
Detail Design
(i.e. How to make)
Physical Completion
& Inspection/ IQ
Setting-to-work
Regulation & Adjustment
Testing/ OQ
Performance
Testing/PQ
Commissioning Plan/PQ
Test Plan
Build
(FAT) / OQ Test Plan
Impact Assessment
Design
Development
(PDI) / IQ Test Plan
USER
USER AND
SUPPLIER
SUPPLIER
The project (s)
n New facility, utilities,equipment
Baseline approach from the start (well alomost)
n Old facility
Poor previous validation
Equipment quality not of a good standard
Unknown ownership
Baseline approach to create a line in the sand.
Old Sytem Detail
n Sterile products line
n Equipment older than the ark
Filling machine supplier no longer exists
Computer systems unsupported
Would not meet current standards
n No URS
n No drawings
n No user manuals
n No validation to speak of.
Old System Validation Approach
n Complete GA/IA confirm direct impact system/equipment
n Basic IQ catalogging and locating data where available
n Basic OQ confirmation of suitability of existing SOPs
n Introduction of backup systems, tighter production control, etc
where possible
n Position statement detailing suitability of system to todays
standards
n Ongoing trending of data
Note:
n This is not watertight!!
What if the
FDA arrive?
New System Detail
nSterile products line
nEquipment new and shiny
nURS defined and approved
nDrawings, user manuals etc available
nTeam defined for all aspects of work (part dedicated).
New System Validation Approach
n Detailed URS problems from the start
A good start
Asked for the right things
Covered validation and documentation requirements
n Requirements from supplier at every stage:
Planning phase
Design Phase
Construction Phase
Testing Phase
n The Purchase Order
n The attempt to fix things.
New System Validation Approach
nIQ
- not all documentation arrived
nOQ
- problems but not major
temperature control freezers
HVAC control
vendor documents
nPQ (some equipment)
- amount of data difficult freezers, autoclaves
-highlighted more info early on reduces work at PQ.
The Good
n New Facility
Highlighted what needed to be validated up front
Rationalised why certain items would not be validated
Documented approvals
Clear minimalist approach to validation
Use of commissioning data
n Old facility
Highlighted gaps/problem areas up front
Put fixes in place ahead of validation work completion
Created review of existing data and cross referenced
where applicable.
The Bad
n New Facility
Small project team, difficult to review all documents
Different agendas for different departments
No clear project manager until late into the project
Changes to protocol formats
n Old Facility
Attempts to get data for old equipment difficult
Engineering/Production understanding poor
Site management expectations difficult to manage
SOPs vague.
The Down right ugly!!
n New facility
Project planning out of sync
FMS system pressure transducers blown
Validated freezer to wrong set point
HVAC validation started too early, repeated
Underestimated autoclave load patterns
Change of cleaning agents
n Old System
Autoclave cycle failures
Vial washer failures
Filling machine now obsolete
Half fridges/freezers/incubators failed mapping.
Comments on the baseline guide
Issues
n Approval bottlenecks
n Support/technical bottlenecks i.e engineering,
production access, etc).
n Baseline guide helps in streamlining but it is limited
in its application without the project efficiency &
support structure
n With no support structures in places (which aren't as
visible and measurable).... you'll struggle
n Does not set out approach for indirect systems (well
enough, some take longer to validate and impact
upon direct systems so should be done 1st.
n More guidance is needed on standard rationales.
Aim of the guide is consistency across industry.
More examples of equipment impact by processes /
stage of processing would be useful.
Comments on the baseline guide
Positives
n It works..... it helps with planning, resourcing up and actually
presents you with a standard risked based model of what to validate
and when......
n Comforting to know it echoes ISPE white paper and the new FDA
thinking on risk assessment
n The process highlighted the direct and critical direct systems quickly
n In a fashion its helped us define our critical spreadsheets to validate
also...... those that are directly affect product release / recall, etc.
The guide and rationale can be applied to IT systems and
spreadsheets /databases
n Having a fixed approach is great, but every company needs to take
the same approach
n Relies heavily on good commissioning data.
Learning Points
n Always appoint a project manager
n Ask for the information, tie it into the purchase order
n Control access to buildings at all stages
n Get handover certificates from suppliers
n Dont try to nurse equipment through validation
n Internal expert/external help do you know what you have?
n Training time is essential
n 24 hour working is not always the answer
n Plan to have more people than you need
n Agree protocol formats early on
n Validation tells it like it is!
Validation
the Easy
Way
Thank you for your attention
lynn.edwards@gb.abb.com
Questions?
Questions?