Transcript Document

Best Automation Practices
in a Greenfield Startup
10 March 2015
Jay Roderick
Sr. Validation Mgr.
Baxter Healthcare
Jonathan Wood
Sr. Mgr. Engineering
Sequence
AGENDA
• Introduction
• Baxter Overview
• Regulatory Objectives
• Automation Design Workflow
• Obstacles to Overcome
• Revised Automation Design Workflow
• Effect on Automation and Equipment C&Q
• Summary
• Q&A
Baxter Overview (Program Covington)
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Announced plans in April 2012 to build a
greenfield campus near Covington, Georgia
Capital investments at site to exceed $1 billion over next 5 years
Create more than 1,500 full-time positions in Georgia and more than
2,000 jobs in total across multiple US locations
More than 1 million total gross square feet on 160-acre site
Program Covington by Sub-project
S
Y2
Y1
U
W2
W1
F
I
D
Q
A
E
C
B
Support Growth of PlasmaBased Therapies
• Covington site will significantly increase Baxter
network capacity for biotherapeutic therapies
• Products to be manufactured include:
– Immunoglobulin (IG) therapy for patients with
primary immunodeficiency diseases (PI) and
multifocal motor neuropathy (MMN)
– Albumin products, which are primarily used as
plasma-volume replacement therapy in critical
care, trauma, and burn patients
Regulatory Landscape
Regulatory Foundation
Quality Expectations
2005:
ICH Q8, ICH Q9
2006:
FDA: Quality Systems Approach to
Pharmaceutical cGMP Regulations
2007:
ASTM E2500-07
2008:
ICH Q10, EU GMP Vol. 4 update,
Annex 20
2011:
FDA: Process Validation: General
Principles and Practices
Pharmaceutical and
Biopharmaceutical Products:
- Safe
- Efficacious
- Correct Identity
- Perform consistently as
described in the label,
over their shelf life
- Manufactured in a
manner that ensure
quality
Commissioning, Qualification and Validation Planning
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Identify the requirements and impact of this project
Strategy Document
Define the scope
Identify activities that will be managed
Define company/department responsibilities
Site Validation Master Plan
Risk Assessments
Perform detailed process Risk Assessments
Perform robust Design Review / Design Qualification
Design Verification (DR/DQ)
Describe commissioning and leveraging strategy
Describe the strategy for computers/automation
Identify documents to be developed and managed
Identify a suitable approach to process validation
Validation Plans
Commissioning Plans
Quality System Integration for a Greenfield Project
Overall Project
Quality Systems
Good
Engineering
Practice (GEP)
Design &
Construction
Construction Quality
Management Plan
(CQMP)
Validation
Quality System
Design
Qualification
Risk
Management
Start-up
Vendor Quality
Commissioning
Qualification
Quality System Processes – Key to Regulatory Compliance
Ongoing Operations and Continuous Improvement
General Business
Process
Utilization and Cost
Accounting
Business
Improvement
Opportunity
Business Process for
Project Management
Owner Acceptance
of System / Facility
GEP Activities
Quality System Process
See Chapter 2. Figure 2.3
See Chapter 2. Figure 2.3
Start of Commercial
of Clinical Use
Acceptance and
Release – Cert. of
Qualification for Use
Routine Preventive
Maintenance and
Calibration
Audits and Reviews
Demand
Maintenance and
Changes
Quality Performance
Monitoring and
Periodic Review
Engineering Change
Management (Noncritical Aspects)
QA. Preapproved
Change Control
(Critical Aspects)
Design Reviews
Quality Risk
Assessments DQ (if
applicable)
Commissioning
(Verification) of
Drawings
C&Q Quality Plan
Commissioning
Reports
Review of Critical
Aspect Validation
Modified Facility for
System Returned to
Use
Acceptance and
Release Requalified
Early and continued investment
in:
• Design Reviews
• Quality Risk Assessments
• Design Qualification
[ISPE: Applied Risk Management for Commissioning and Qualification]
Quality System Processes1
design
development.
control,
communication
and review of risk
to the quality of
the product and
the safety of the
patient.
verification that
the proposed
design of the
facilities, systems
and equipment is
suitable for the
intended purpose.
A robust Design Review is critical to proper system operation obtaining
Regulatory Compliance within budget and schedule constraints
(1) Slide taken from ISPE Reg. Compliance Presentation (R. Chew, C. Susla)
Regulatory Compliance
Design Review
Quality Risk Assessment Part I
Planned and
systematic
Design Qualification
Systematic
reviews of
process for the
specifications,
QRA Part II
The documented
assessment,
designs and
Design Review / Design Qualification Approach
• Design Verification = 2 steps = DR + DQ
 Requirements defined in approved procedure and templates
 Assessment that the design is suitable for the intended
purpose
 For System’s Critical Aspects – DR/DQ provides traceability for
each requirement to the engineering control strategy
• ASTM E 2500-07
 Planned and systematic reviews of specifications, designs,
and design development and continuous improvement
changes performed as appropriate through the life-cycle of the
manufacturing system
ASTM E2500 – 07 Process Flow
PRODUCT
KNOWLEDGE
GOOD ENGINEERING PRACTICE
PROCESS
KNOWLEDGE
REQUIREMENTS
DESIGN
SPECS
VERIFICATION
REGULATIONS
RISK MANAGEMENT
COMPANY
STANDARDS
DESIGN REVIEW
CHANGE MANAGEMENT
ACCEPTANCE
RELEASE
V-Model (Ideal World)
PLAN
QP
REPORT
URS
Report
PQ
SPECIFY
VERIFY
FRS
OQ
SDD
IQ
CODE
Code
FAT/
SAT
Automation Design Workflow
Develop FRS
Team reviews
Design
Integrator
addresses
issues
Identify Design
Gaps
Integrator
releases Design
SAT with
Process and
Manufacturing
Preliminary
Design Review
Informal
Design Review
with Integrator
Perform Design
Qualification
Initiate
Engineering
Punchlist
Release FRS to
Integrator
Proceed to
Startup
Functional Requirements Compilation
P&IDs
SOO
CPPs
URS
Manufacturing
Input
FRS
Process Eng.
Input
FRS Content Variables
FRS Content = ƒ(a) + ƒ(b) + ƒ(c) + ƒ(d) + ƒ(e)
a = Sequence of Operations
b = P&ID (instrumentation feedback)
c = Process Engineering Input (Process Knowledge)
d = Manufacturing Input (Product Knowledge)
e = Varying experience (leads into inconsistency
across process areas)
Preliminary Design Review
• Assemble team of SMEs consisting of Process
Engineers, Automation Engineers, and
Manufacturing
• Systematically break down FRS with P&IDs to
ensure content achieves desired functionality
• Establish Engineering Punchlist to document
open issues that need to be addressed
Turnover to Integrator
• Approve FRS internally and turnover to
Integrator
• SMEs (Process, Manufacturing, and
Automation) to meet with Integrator to
ensure requirements are understood
• Answer questions from integrator throughout
software development period
Integrator Delivers Design…Now What?
• All SMEs from Design Review group
review and provide comments
• Integrator addresses comments
• SAT is scheduled
Site Acceptance Testing
• Attended by same SMEs (Process,
Manufacturing, and Automation)
• Also may include Validation representation, in
the event documentation will be leveraged
• Opportunity for team to see graphics,
equipment module functionality, and recipe
progression in an offline environment
Design Qualification
• Pre-requisite: Punchlist items from SAT are
resolved
• Documented verification that the proposed
design of the facilities, systems and
equipment is suitable for the intended
purpose
• Proven through traceability of URS, FRS, and
SDS
• Proceed to Start-up
Obstacles to Overcome
• Process Engineering and Manufacturing will be attending
Equipment FATs during same time frame as Software Design
Reviews, so limited time for thorough design reviews
• Design specs are typically code dumps that are difficult to navigate
through to provide meaningful input
• Design is constantly changing, which adversely impacts software
design
• Green-field projects are comprised of resources with various
backgrounds and have multiple opinions about functionality of
equipment
• Lack of Communication (As design changes, the team must be
notified)
• Multiple issues lists for documenting engineering changes
• Pressure to streamline C&Q activities leads to starting too early
with verification deliverables
Revised Automation Design Workflow
Identify Similar
Control
Schemes
Integrator
releases Design
Convert Design
to Reviewable
Format
Develop FRS
Informal
Design Review
with Integrator
Team reviews
Design
Identify Design
Gaps
Release FRS to
Integrator
Integrator
addresses
issues
Proceed to
Startup
Preliminary
Design Review
Initiate
Engineering
Punchlist
SAT with
Process and
Manufacturing
Perform Design
Qualification
Identify Similar Control Schemes
• Review P&IDs and Sequence of Operation
documentation to identify similar control
schemes for Utilities and Process
• Typically applies to Temperature Control,
Agitator Control, and Pressure Control
• Creates consistency and also eliminates
redundant testing downstream
• Only test unique schemes once
Design Specification Example
• Requires navigation through
multiple database (EMs),
recipe, and unit class docs
for thorough review
• Not a trivial task
• Review alone is an
insufficient Design Review
• Convert to more usable
format to ensure a robust
review from Process and
Manufacturing
Converted SDS Format
Example of an Inlet Header for a Buffer Vessel (EM-V100-INLT)
Header EM
Description
Initialize
Charge WFI
Charge GAA
V100-YV01
Sprayball Inlet
Closed
Open
Closed
V100-YV02
Diptube Inlet
Closed
Closed
Open
V100-YV03
GAA Inlet
Closed
Closed
Open
V100-YV04
Alcohol Inlet
Closed
Closed
Closed
V100-YV05
Agitator CIP
Closed
Closed
Closed
RECIPE PROGRESSION
Forces Process and Manufacturing to revisit P&IDs to ensure
software design achieves desired functionality
Effect on Automation and Equipment
CQV Activities
• If class-based functionality is not effectively
used, more unique testing will be required for
Automation and Equipment
• Inadequate Design Reviews will lead to issues
discovered as part of CQV activities and will
result in Over-budget and Delayed Schedule
• Waste commissioning that was intended to be
leveraged towards qualification
V-Model (Real World)
• Lack of Process/Product
Knowledge leads to reprogramming and multiple
iterations of qualification
OV
FRS
IV
SDD
Code
FAT/
SAT
• Design Qualification doesn’t
catch inadequate Design
Review
• Delays due to reprogramming will adversely
affect schedule and budget
• Introduces parallel activity of
validation and change
control
Ultimate Outcome
OV
FRS
SDD
IV
Code
FAT/
SAT
Better Outcome
Summary
• Variability identified as part of FRS Content
Equation can be mitigated by robust design
reviews with key personnel
• Risk-based testing methods will not be
effective if the design reviews are not
adequate
• Creates snowball effect that leads to a project
that is over-budget and delayed
Q&A
FRS Outline
1.
2.
3.
4.
5.
6.
7.
8.
Overview (includes Purpose and Scope)
Operator Interface (Graphics to reflect P&IDs)
Devices (Analog & Discrete that feedback to DCS)
General Control (Equipment Module Functionality,
i.e. TCMs, Agitators, Pressure Control)
Automated Operations (Batch Control – S88)
Interlocks
Alarms (CPPs)
Interface with Other Systems (Packaged Systems)