Learn How to Perform a Risk-based Impact Assessment · Guidance for Industry Q9 Quality Risk Management page 3 ... Rational behind the scene ... How to Perform a Risk-based Impact
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[ 1 ]CONFIDENTIAL
Learn How to Perform a Risk-based Impact
Assessment
Jorge A. Cordero-Monroig; BSChE, MBA-GM
Site Validation and Metrology Lead
B+L Greenville Solutions Plant
Phone: 864-991-7638
Email: jorge.cordero@bausch.com / corderomonroig@yahoo.com
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Agenda:
Concepts and Definitions
Why use Risk- Based approach?
What are the ground rules?
How to Perform a Risk-based Impact Assessment?
Interactive Exercise:
Using real life examples, participants Risk-Based Impact Assessment
Q&A
Learn How to Perform a Risk-based Impact Assessment
[ 3 ]
Learn How to Perform a Risk-based Impact Assessment
Concepts and Definitions
Risk Management is the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks. http://www.businessdictionary.com/definition/risk-
management.html#ixzz3BVbyA7DN
“Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle” Guidance for Industry Q9 Quality Risk Management page 3 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073511.pdf
Impact assessment is the process of evaluating impact on product quality based on new or changes in equipment, components, facilities, process, and/or systems.
Equipment, components, facilities, processes, and/or systems shall be designed to meet the product intended use and suitable to meet the cleaning and maintenance
requirements.
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Learn How to Perform a Risk-based Impact Assessment
Concepts and Definitions
Two categories of Risk Management:
Quality Risk - Product Critical (GMP Risk)
Business Risk – Business Critical(Non-GMP).
Quality Risk Management Approach are based on clear process understanding and potential impact on patient safety. In other words, Quality Risk Management is based on GMPs equipment, components, facilities, processes, and/or systems and how the patient safety could be impacted.
Business Risk Management is focused to ensure that business goals are accomplished. Therefore, make sense for business implement Quality Risk Management.
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Learn How to Perform a Risk-based Impact Assessment
Concepts and Definitions
Risk Based Impact Assessment refers to the evaluation of the equipment, components, facilities, processes, and/or systems based on the intended use, product impact, and patient safety.
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Why use Risk- Based approach?
Regulatory background
Business benefits
Rational behind the scene
Learn How to Perform a Risk-based Impact Assessment
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Why use Risk- Based approach?
Regulatory / Industry Standard background:
ASTM E2500 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
GAMP 5 - A Risk-Based Approach to Compliant GxPComputerized Systems
ICH: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
Q9 Quality Risk Management
21 CFR Part 211 and 820 (Intended Use)
Clarification Note: ASTM E2500 is not a legal requirement but a standard guide with the purpose of providing guidance and best practice to validation activities.
Learn How to Perform a Risk-based Impact Assessment
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Why use Risk- Based approach?
Business benefits
Cost Effective:
Identify areas that will require more evaluation, adjustments, or re-design prior to the implementation.
Avoid waste effort and duplication while minimize down time.
Keep Us In Compliance:
Provide controls to identify risk.
Provides a clear justification of the decision made based on risk criticality.
Learn How to Perform a Risk-based Impact Assessment
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Learn How to Perform a Risk-based Impact Assessment
Why use Risk- Based approach?
Rational behind the scene
You know your process and the impact that change may have in your product.
Identify and evaluate every single risk during the impact assessment and focus in what is really important.
Classify the impact of the area to be assessed between Product Critical (Direct Impact) or Business Critical (Indirect Impact or No –Impact), and focus the effort based on criticality.
Minimize or redirect the workload to what is really important.
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Learn How to Perform a Risk-based Impact Assessment
What are the ground rules?
Risk Based approach Impact Assessment should be focusing on product and patient impact.
Every Equipment, Component, Facility areas, System, and Processes need to be classified between Direct impact, Indirect Impact, or No Impact to the product.
Direct Impact = GMP Critical
Direct impact in the safety, identity, potency-strength, quality and/or purity of the product.
Direct impact to regulatory aspect such as labeling, and evaluation, generation, archiving, and reporting data that is used for release
Maintain, control, and monitor environmental conditions to preserve product quality
Used to clean, sanitize, or sterilize to preserve product quality
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Learn How to Perform a Risk-based Impact Assessment
What are the ground rules?
Indirect/No Impact = Business Critical
Elements that affect the ability to manufacture and operate efficiently such as Boilers, Plant Steam, Compressed Air, Secondary / Tertiary Packaging
Elements that affect customer satisfaction such as cosmetic defects, failures in deliver on time, and missing promotional material
Systems that evaluate and monitor operation efficiencies.
Equipment that help to improve operation efficiencies
Must comply with GEP (Good Engineering Practice): Fitness to purpose, reliable, cost effective.
Design follow industries guidance and statutory requirements taking inconsideration GMP, Safety, Health, Environmental, ergonomic, operational, and maintenance requirements.
Proof professional and competent design, construction, installation testing, and commissioning including appropriate documentation such as design concepts, as build drawings, manuals, certifications, maintenance instructions, and test records.
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Learn How to Perform a Risk-based Impact Assessment
What are the ground rules?
Define the approvers
User
Stakeholder
Engineering / Technical Service
Validation
Quality
BE CONSISTENT
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How to Perform a Risk-based Impact Assessment?
Purpose of the Impact Assessment
Determine Equipment, Components, Facility areas, System, or Processes criticality based on impact to Product and Patient safety.
Determine level of qualification/validation required for new Direct Impact Equipment, Components, Facility areas, System, or Processes.
Determine level of qualification/validation required when changes are made in qualified/validated Equipment, Components, Facility areas, System, or
Processes.
Learn How to Perform a Risk-based Impact Assessment
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How to Perform a Risk-based Impact Assessment?
What areas are impacted?
Some of the areas to take in consideration are:
Products
Regulatory aspects
Environmental conditions
Cleaning, sanitization, or sterilization processes
Learn How to Perform a Risk-based Impact Assessment
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How to Perform a Risk-based Impact Assessment?
Identify risks specific to the patient safety, product quality, data integrity, process, and/or critical functions
First step is to develop a method that consistently identify the risk associated to equipment, components, facilities, process, and/or systems.
Learn How to Perform a Risk-based Impact Assessment
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Learn How to Perform a Risk-based Impact Assessment
How to Perform a Risk-based Impact Assessment?
E/C/F/S/P Impact to Product
1. Does E/C/F/S/P come in direct physical contact with the product?
2. Does E/C/F/S/P produce or distribute a material that has direct contact with product?
3. Is the E/C/F/S/P used in cleaning, sanitizing or sterilizing?
4. Does the E/C/F/S/P create or maintain a specified environmental condition required to preserve product quality?
5. Does the E/C/F/S/P produce, monitor, evaluate, store or report data used to accept or reject product or GMP materials or data used to support Regulatory Compliance-Practices?
6. Does the E/C/F/S/P perform a critical process step or operation in the manufacturing, processing, packaging, labeling testing or holding of the product?
No No No No No
Direct Impact
Yes
Indirect Direct Impact
7. Is the E/F/S/P linked to other direct impact systems?
No
No ImpactNo
Yes Yes YesYes Yes
Yes
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Learn How to Perform a Risk-based Impact Assessment
How to Perform a Risk-based Impact Assessment?
Qualification Requirements for New E/C/F/S/P
Does E/C/F/S/P have Operational Functions?
Installation Qualification
Operation Qualification
Is Functional Parameter testing required?
Complete
Is the E/C/F/S/P Function critical to key parameters in the Process?
Performance Qualification
Complete
NoNo
No
Process Validation
Yes
Yes Yes
Yes
Direct Impact
Does E/C/F/S/P support direct Impact System?
Indirect Impact
Commissioning , Eng. Studies, Calibration, etc…
Yes
No Impact
No
No
Does E/C/F/S/P directly Impact product Quality?
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Learn How to Perform a Risk-based Impact Assessment
How to Perform a Risk-based Impact Assessment?
Changes to Qualified/Validated E/F/S/P
Does change affect installation?
Does change affect operational functions?
Does change affect the performance of the EFSP?
Does change affect Process or CPPs?
Yes
Yes Yes Yes
Yes
No
NoNo
No
No change request or Qualif./Valid. needed.
Does change impact qualified / validated state?
Change Request required.
Installation Requalification
Operational Requalification
Performance Requalification
Process Revalidation
No
No Installation Requalification required
No Operational Requalification required
No Performance Requalification required
No Process Requalification required
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Learn How to Perform a Risk-based Impact Assessment
How to Perform a Risk-based Impact Assessment?
Establish Impact assessment rational
Answer Yes or No is not enough.
Generate a document, form, or report that define:
Rational of how the criticality of the E/C/F/S/P was assigned.
Rational of why qualification/validation requirements were assigned.
Rational why changes in E/C/F/S/P require or not require re-validation.
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Learn How to Perform a Risk-based Impact Assessment
"Determine Equipment/Facility/System/Process Impact to Product"
Project: Title/Number
Equipment/
Facility/ System/
Process (EFSP)
Brief description of
function
Does the
EFSP
come in
direct
physical
contact
with the
product?
Does the EFSP
produce or
distribute a
material that
has direct
contact with
product
Is the EFSP
used in
cleaning,
sanitizing or
sterilizing?
Does the
EFSP create
or maintain a
specified
environmental
condition
required to
preserve
product
quality?
Does the EFSP
produce, monitor,
evaluate, store or
report data used
to accept or reject
product or GMP
materials or data
used to support
Regulatory
Compliance-
Practices?
Does the EFSP
perform a
critical process
step or
operation in the
manufacturing,
processing,
packaging,
labeling testing
or holding of the
product?
Direct
Impact
Results
Fill out this section
only if EFSP is
NOT considered
Direct- Is the
EFSP linked to
other direct impact
systems?
Equipment 1 Description 1No No No No No No No Impact Yes
Indirect
Impact
Equipment 2 Description 2No No No No No No No Impact No
No
Impact
Equipment 3 Description 3No No No No No Yes
Direct
Impact N/A
No
Impact
Comments:
Comments and justifications here
Performed By/Date:
Validation Engineer:
Approved By/Date:
Validation Lead:
Area Owner Manager:
QA:
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Learn How to Perform a Risk-based Impact Assessment
"Determining Qualification Requirements for New Equipment/Facility/System/Process"Project: Title/Number
Equipment/
Facility/
System/
Process
(EFSP)
Brief description of
the change
Does EFSP
directly
impact
product
quality?
Does EFSP
have
operational
functions?
Does
Functional
testing
required?
Is the EFSP
function
critical to
key
parameters
in the
process?
ResultsDoes IQ
required?
Does OQ
required?
Does PQ
required?
Does PV
required?
Equipment 1 Description 1No No No No
No Change
Request No No No No
Equipment 2 Description 2
Yes Yes No No
Change
Request and
Qualification
Required Yes Yes No No
Comments:
Comments and justifications here
Performed By/Date:
Validation Engineer:
Approved By/Date:
Validation Supervisor:
Area Owner Manager:
QA:
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Learn How to Perform a Risk-based Impact Assessment
"Changes to Qualified/Validated Equipment/Facility/System/Process" Project: Title/Number
Equipment/
Facility/ System/
Process (EFSP)
Brief description of the
change
Does change
impact qualified
/ validated
state?
Does change
affect
installation?
Does change
affect operational
functions?
Does change
affect the
performance of
the EFSP?
Does change
affect Process or
CPPs?
Results
Equipment 1 Description 1 No No No No NoNo Change
Request
Equipment 2 Description 2 Yes Yes No No No
Change
Request and
Qualification
Required
Equipment 3 Description 3 Yes No Yes Yes No
Change
Request and
Qualification
Required
Comments:Comments and justifications here
Performed By/Date:
Validation Engineer:
Approved By/Date:
Validation Supervisor:
Area Owner Manager:
QA:
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Summary
Define the concept and process of your impact assessment in a SOP.
Develop a method or follow existing method to classify E/C/F/S/P between GMP Critical (Direct Impact) and Business Critical (Indirect Impact/No-Impact).
Focus your Impact Assessment on the intended use, product impact, and patient safety. This will help to minimize or redirect the workload to what is really important and focus the effort based on criticality .
Be consistent
Learn How to Perform a Risk-based Impact Assessment
[ 24 ]
Interactive Exercise:
Using real life examples, participants Risk-Based Impact Assessment
New Autoclave
Upgrade to Legacy HPW and Clean Steam Systems
Replacement of Environmental Monitoring Systems
Non-Validated Lab. Refrigerators/Incubators
Non-Validated Boilers
Update of Labeler control
Adding a new configuration to a Casepackers (Tertiary packaging)
New Mix Tank
Learn How to Perform a Risk-based Impact Assessment
[ 25 ]
Questions and Answers
Learn How to Perform a Risk-based Impact Assessment
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