learn how to perform a risk-based impact assessment · guidance for industry q9 quality risk...

[ 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: [email protected] / [email protected]

mailto:[email protected]

mailto:[email protected]

[ 2 ]

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

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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.

http://www.businessdictionary.com/definition/risk-management.html#ixzz3BVbyA7DN

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073511.pdf

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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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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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Regulatory background

Business benefits

Rational behind the scene


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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.


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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.


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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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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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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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Define the approvers

User

Stakeholder

Engineering / Technical Service

Validation

Quality

BE CONSISTENT

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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.


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What areas are impacted?

Some of the areas to take in consideration are:

Products

Regulatory aspects

Environmental conditions

Cleaning, sanitization, or sterilization processes


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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.


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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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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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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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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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"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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"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:


Approved By/Date:

Validation Supervisor:

Area Owner Manager:

QA:

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"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:


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


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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


[ 25 ]

Questions and Answers


learn how to perform a risk-based impact assessment · guidance for industry q9 quality risk...

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