A brief description about second eddition of C&Q Volume 5. "V" module of validation system obsoluted and risk based aproach described as per cGMP requiremnet.

1. VOLUME 5
COMMISSIONING AND
QUALIFICATION
SECOND ADDITION
PREPARED BY: RAVINDRA KUSHWAHA

2. INTRODUCTION
• The second edition of the C&Q Volume-5 focuses in the approach; the
terminology used is not important as the approach.
• This guide Offer compliant, integrated commissioning and
qualification process that is based on the science risk based
approach.
• The term commissioning and qualification (C&Q) is used to describe
the process for establishing that facilities, systems, utilities and
equipment suitable for the intended use.

3. PURPOSE AND OBJECTIVES
• C&Q approach includes a system risk assessment process the identifies the critical
aspects or critical design elements.
• This guide recognizes industry best practices C&Q and presents concepts that can
assist organizations in meeting regulatory expectations for systems qualification
by:
✓Providing guidance how to apply Quality Risk Management process to C&Q to
establish Critical Design Elements.
✓Defining the focus of an integrated C&Q effort to be the Critical Aspects/
Critical Design Elements and Critical Process Parameters which provide the ability
to deliver the product Critical Quality Attributes.

4. PURPOSE AND OBJECTIVES
✓Defining best practices for User Requirement Specification, Design Review, Design
Qualification, and acceptance and release of the system.
✓Clarifying the change management processes required to support the C&Q
process.
✓Providing Good Engineering Practice Documentation standards.
✓Describing where testing should be duplicated and where it is acceptable to test
once.
✓Addressing integration of equipment automation systems.
✓Providing examples of appropriate C&Q deliverables.

5. SCOPE OF GUIDE
• This guide is applies to systems used by pharmaceutical manufacturers
of human and veterinary drugs, including biological drug products.
• Following areas are not the part of C&Q guide:
✓Product and process development, including identification of any
process requirements that influence system design.
✓Computerized systems software development and testing (ISPE
GAMP 5: A Risk-Based Approach to compliant GxP Computerized
System).

6. SCOPE OF GUIDE
✓Process validation,- including Process Performance Qualification and
Continued/Ongoing Process Verification (ISPE Good Practice Guide:
Practical Implementation of the Lifecycle approach to Process
Validation)
✓Cleaning Validation.
✓Sanitization and sterilization validation.
✓Analytical procedures and method validation.
✓Decommissioning activities (ISPE Good Practice Guide:
Decommissioning of pharmaceutical equipment and facilities.

7. SCIENCE AND RISK BASED C&Q PROCESS MAP
Product Risk
Assessment
Control Strategy
(ICH-Q8)
CQAs
CPPs
Regulatory
Organization/ site,
operational, and
Health/Safety/Env
ironmental
requirements
URS System
Classification
System Risk
Assessment
DR/DQ
C&Q Testing
and
Documentation
Acceptance
& Release
Operation
Periodic
Review
C&Q
Planning
Traceability
Inputs to
C&Q Process
Define
requirements
Design
Specify
Continued
Improvement
Build/
Verify
Accept and
Release
Shaded boxes indicate the major blocks within the process maps.
• The input to integrated C&Q processes include product and process CQAs/CPPs and the application of
QRM to define the control strategy.

8. PROCESS OVERVIEW AND STRUCTURE OF THE GUIDE
• The input to integrated C&Q processes include product and process CQAs/CPPs and the
application of QRM to define the control strategy.
• The steps in the integrated C&Q process are:
✓URS
✓System Classification
✓System Risk Assessment
✓Design Review/Design Qualification
✓Commissioning & Qualification Planning
✓Commissioning & Qualification Testing and Documentation
✓Acceptance and Release
✓Periodic Review

9. PROCESS OVERVIEW AND STRUCTURE OF THE GUIDE
• Support programs and strategies for implementation also included in
this Guide.
✓Vendor Assessment for C&Q Documentation purposes.
✓Engineering Quality Process
✓Change Management
✓Good Documentation Practices for C&Q
✓Strategies for implementations of Science and Risk Based C&Q
Process

10. RATIONALE FOR C&Q SECOND ADDITION
• C&Q also combines concepts from regulatory guidance like from EMA, FDA, ICH, and
the following ISPE documents that are superseded with this revision:
✓ISPE Baseline Guide: Volume 5 (First Addition)
✓ISPE Guide: Science and risk based approach for the delivery of facilities, system and
equipment
✓ISPE good practice Guide: Applied risk management for commissioning and
qualification

11. RATIONALE FOR C&Q SECOND ADDITION
• Certain aspect of C&Q described in previous edition of this guide are retired and
replaced with QRM and GEP. These include:
✓Component Criticality Assessment
Since CDEs are identified as an output of the System Risk Assessment, assessment of the
criticality of each system component is unnecessary.
✓Enhanced Commissioning
This guide describes how the level of testing can be aligned with criticality and intended
purpose of the system.
✓Enhance design Review
This guide describes an approach for performing effective DRs using the System Risk
Assessment to achieve DQ.

12. RATIONALE FOR C&Q SECOND ADDITION
✓Enhanced Documentation
Good Documentation Practice are defined in the guide.
✓Indirect Impact
The term is not used. The guide describes C&Q for systems based on whether a system
has direct product impact or not.
✓V – Model
The integrated C&Q approach provides a lifecycle C&Q approach and is represented
by a different process map. The V-model appropriately represented the links between
the design process and testing, but did not incorporate a risk assessment process based
on product quality.

13. REFERENCES
• ISPE Baseline Guide: Volume 5 (First Addition)
• ISPE Baseline Guide: Volume 5 (Second Addition)
• ASTM E2500-13
• GEP
• ICH Q8
• ICH Q9
• ISO/IEC/IEEE 24765
• FDA 2006 Quality System Guidance

14. END OF SLIDE
Thank You