E D

R V
S E
R E
Demystifying Your Questions T S
on the
H
G Vol. 5
Revised C&Q Baseline Guide R I
Townhall and Panel Q&A L L
- A
7 July 2020
P E
1100 – 1200 EDT
I S
2 0
2 0
©
Moderators Panelists
E D
R V
S E
R E
T S
Stephanie White
Sr. Manager, Engineering
H Nicholas Haycocks
Senior Specialists QA
Zachary Luce
Senior Consultant

IG
Projects Amgen Inc. Project Pharma
Amgen, Inc.

L R
Steve Wisniewski
AL
Principal Compliance Consultant,
CAI
-
P E
I S
2 0 Nathan Temple
CQV Business Area Leader
Alexander Mendoza
C&Q Lead, Global Engineering

2 0 CAI Takeda Pharmaceuticals

© Connecting Pharmaceutical Knowledge ISPE.org

 Moderator
E D
Steve Wisniewski R V
Principal Compliance Consultant,
S E
CAI

R E
S
Topics: System Risk Assessment (SRA), IT/GAMP 5
T
Key Points:
H
•

R IG
SRA is a new Risk Assessment Tool developed to support the QRM,
C&A integrated lifecycle process. The Tool received input during
Regulatory and peer review prior to publishing.

L
• L
SRA deliverables include the engineering and automation design

- A elements, and procedures required to provide a focus for systems

being fit-for-purpose. In addition the SRA identifies critical

P E •
instruments associated with critical alarms.
SRA recognizes that major pharmaceutical equipment manufactures

I S have incorporated engineering and automation control elements into

their equipment.

20 • The C&Q Guide clearly notes that the QRM process applied to

20 software development defined in GAMP 5.

© Connecting Pharmaceutical Knowledge ISPE.org 3

 POLL #1
E D
What is your company’s status or plans for R V
moving forward its C&Q/Validation Quality
S E
System?
R E
 Implemented a QRM based CQV program. T S
H
principles
R IG
 Implement a QRM based CQV program based on the guide

company L L
 Implement a QRM based CQV program developed by our

- A
 Continue to implement our traditionally based CQV Program
E
 Continue to implement our V-Model/Leveraged CQV Program
P
I S
2 0
2 0
© Connecting Pharmaceutical Knowledge ISPE.org 4
 Panelist
E D
Stephanie White R V
Sr. Manager, Engineering Projects
S E
Amgen, Inc.

R E
Topics: User Requirements Specifications (URS)
Key Points:
T S
•
H
Critical Quality Attributes (CQAs) and Critical Process Parameters

IG
(CPPs) are key inputs into a URS required to support the Quality
Risk Management based Commissioning and Qualification process,
R
and are identified prior to User Requirement generation.
L
•

AL URS documents can be written around a platform to address the

requirements of a multi-purpose operation.

- • URSs are living documents that are updated as requirements

P E change during any phase of a project or additional risk controls are

identified.

I S • The URS document should not contain the content of engineering

20 specifications and standards, the means by which user

20 requirements are met, or contain contractual contract requirements.

© Connecting Pharmaceutical Knowledge ISPE.org 5

 Panelist
E D
Nicholas Haycocks R V
Senior Specialists QA
S E
Amgen Inc.

R E
T S
Topics: Quality Unit, System Risk Assessment (SRA)
Key Points:
H
•
IG
There are many ways of ensuring quality oversight of the C&Q
R
process – the guide provides some options for companies to

L L
consider.

- A• Steve has added a few notes about the SRA – let me add this - the
SRA provides benefits to Quality – essentially it’s a documented

P E rationale defining design aspects that are critical

I S
20
20
© Connecting Pharmaceutical Knowledge ISPE.org 6
 Panelist
E D
Zachary Luce R V
Senior Consultant
S E
Project Farma

R E
S
Topics: Verification (C&Q Execution)
T
H
IG
Key Points:
•
R
Verification is the activities within the C&Q process that document
the manufacturing facility, system, utility, and equipment are suitable
L
AL
•
for intended use.
Verification activities should be considered during planning in order
- to minimize need for retesting.

P E • Verification activities include FAT, SAT, RI, IQ/OQ, and PQ. The next
test activity may be started with acceptance of results and

I S assessment that open items will not impact subsequent testing.

20 • Acceptance of vendor testing is dependent on vendor qualification

process and alignment to C&Q planning.

20
© Connecting Pharmaceutical Knowledge ISPE.org 7
 Panelist
E D
Nathan Temple R V
CQV Business Area Leader
S E
CAI

R E
Topics:
T S
Design Review/Design Qualification (DR/DQ)
Key Points:
H
•
IG
DR is a key enabler for GEP and directly supports C&Q planning
R
scope and execution

L
• L
DQ is a recommended practice by BG5, EU requirement and

- A•
increasingly expected
DQ provides documented verification that the design will result in a

P E system that is suitable for the intended purpose.

I S • Expectation that commissioning protocols can be pre and post

approved by Engineering only since the Quality unit pre-approved

20 the CAs/CDEs, their associated acceptance criteria and verification

20 strategy within DQ

© Connecting Pharmaceutical Knowledge ISPE.org 8

 Panelist
E D
Alexander Mendoza R V
C&Q Lead, Global Engineering
S E
Takeda Pharmaceuticals

R E
Topics: Periodic Review
T S
Key Points:
H
•
IG
Periodic Review (also known as Validation Maintenance) ensures
R
that systems continue to be in a qualified state.

L
• L
Having an established Periodic Review program is a regulatory

- A•
expectation.
Frequency of periodic review activities is based on risk, level of

P E process understanding and process performance, and regulatory

requirements.

I S
20
20
© Connecting Pharmaceutical Knowledge ISPE.org 9
 E D
R V
S E
R E
T S
Q&A H
R IG
LL
- A
P E
I S
20
2 0
©
Moderators Panelists
E D
R V
S E
R E
T S
Stephanie White
H Nicholas Haycocks
Zachary Luce

R IG
Topic: User Requirements
Specifications (URS)
Topic: Quality Unit & System
Risk Assessment Topic: Verification (C&Q
Execution)

L L
Steve Wisniewski
Topic: System Risk Assessment,
IT/GAMP 5
- A
P E
I S
2 0 Nathan Temple Alexander Mendoza

2 0 Topic: Design Review/Design

Qualification
Topic: Periodic Review

© Connecting Pharmaceutical Knowledge ISPE.org

POLL #2
E D
What is your company’s status or plans for R V
moving forward its C&Q/Validation Quality
S E
System?
R E
 No changes. We have implemented a QRM based T S
CQV program. H
recommend R IG
 Based on the information I’ve learned today; I will

L
 Plan to implement a QRM based CQV program L
developed by yus
- A
 Continue to implement our traditionally based CQV
Program
P E
I S
 Continue to implement our V-Model/Leveraged CQV
Program
2 0
2 0
© Connecting Pharmaceutical Knowledge ISPE.org 12
Q&A D
V E
Contact Information Upcoming Webinars
E R
E S
Steve Wisniewski, CAI
Steve.Wisniewski@cagents.com GAMP® 5, FDA CSA,R and the Future of Computer
Stephanie White, Amgen
Wednesday,T
S
Systems Validation Extended Learning
swhite02@amgen.com

G H 29 July 2020, 1000 – 1130 EST

Nick Haycocks, Amgen
haycocks@amgen.com
R I
Nathan Temple, CAI
Nathan.Temple@cagents.com
L L More Than Just Technology: A Holistic Approach to
Zach Luce, Project Pharma
zacharyluce@projectfarma.com - A Pharma 4.0
Tuesday, 22 September 2020, 1100 – 1200 EST

P E
Alex Mendoza, Takeda Pharmaceuticals
alexander.mendoza@takeda.com
I S Topic Ideas or Feedback?
2 0 Send to ispeak@ispe.org
2 0
© Connecting Pharmaceutical Knowledge ISPE.org 1313