Professional Documents
Culture Documents
Presentation by
Sasidharan S Menon
Subject Matter Expert (SME) Design and Evaluation
Controlled Environments for Contamination Control
contact@sasidharanmenon.com
www.sasidharanmenon.com
contact@sasidharanmenon.com
www.sasidharanmenon.com
contact@sasidharanmenon.com
www.sasidharanmenon.com
Pharma Dev.
(Q8)
Pharma Quality
Quality Risk Mgmt.
Systems.
(Q9)
(Q10)
Q8 Pharma development
Collecting the knowledge needed.
Q9 Risk Management
Application to our needs using the knowledge.
QbD
Verification Vs Qualification
contact@sasidharanmenon.com
www.sasidharanmenon.com
Original C&Q
Guidance
Volume 5
Design
development
Enhanced design
review
PQ
Commissioning
Process
validation
IQ & OQ
New ASTM
Approach
Volume 12
QA change control
Design
development
Design review
Verification testing
contact@sasidharanmenon.com
www.sasidharanmenon.com
PQ
Process
validation
contact@sasidharanmenon.com
www.sasidharanmenon.com
contact@sasidharanmenon.com
www.sasidharanmenon.com
contact@sasidharanmenon.com
www.sasidharanmenon.com
contact@sasidharanmenon.com
www.sasidharanmenon.com
Elimination by Design
Elimination by Automated Control
Elimination by Procedural Controls
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Role of Design/Engineering:
Documentation
Clearly define design/engineering phases
Risk assessment becomes an integral part of design phase
Basis of design : Design development
Critical Process Parameters
Design review
C & Q Master plan
Vendors/Contractors producing design documents
Who is in control?
Documentation management
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Key Concepts
Good Engineering Practice (GEP):
Key Concepts
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Key Concepts
Use of Vendor Documentation
If inadequacies are found in the vendors quality systems,
technical capability, or application of GEP, then the user or
SME may choose to mitigate potential risks by applying
specific, targeted, additional verification checks or other
controls rather than simply repeating vendor activities and
replicating vendor documentation.
Key Concepts
Quality by Design
To ensure that quality attributes and requirements are
designed-in during the specification and design process.
Pre tender meeting of prospective vendors are important
to inculcate user requirements and expected quality
attributes.
Assurance that all systems are fit for purpose and not
relying solely on verification after installation, but be
achieved by a planned and structured verification
approach applied throughout the systems life cycle.
contact@sasidharanmenon.com
www.sasidharanmenon.com
contact@sasidharanmenon.com
www.sasidharanmenon.com
Be Aware
Understanding of the product, process, manufacturing
steps and facilities is critical.
Early agreement between Management, Engineering,
Quality & other stake holders is essential before moving
in new direction.
Clear understanding of Engineering Documentation is
required.
Identification of SMEs is of utmost importance.
contact@sasidharanmenon.com
www.sasidharanmenon.com