Risk Assessment in Life Sciences

8/6/2019 Risk Assessment in Life Sciences

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RISK ASSESSMENT IN LIFE SCIENCES


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What Is Risk Assessment?

Risk assessment is the process of Identifying,

Estimating, and

Evaluating the nature and severity of risks associated with a product.

Risk assessment consists of identifying and characterizing the nature,frequency, and severityof the risks associated with the use of aproduct

Risk management is an iterative process designed to optimize thebenefit-risk balance for regulated products Requires ongoing review and evaluation


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Risk Assessment


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Risk assessment is the actuarial architectural development for valuebase processes ongoing in the organization

Life science validation is all time key vital process to deliver qualityproducts in to the market

The validation process is an extinguishing prominent procedure toimplement the quality driven methodologies to pertain the processparadox

The potential validation requirement commonly includes the GXP andPM of GXP for clearances of concerned regulatory body


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Pharmaceutical validation and R&D validation , Product development

validation and Drug lifecycle validation are comprised areas to have aprofound validating QMS

Of upgrading regulatory demands the flow of validation processmaintenance is defining criticality

Arisen criticality calling for the development of Risk basedValidation and Risk assessment in Life science Validation


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The business objectives achievement for particular pharmacorporations on global scale and to make finest due diligence withthe connected strake holders in paving the demand of definingstrategic solutions with Risk based Validation

Activity, risk factor and risk potential and predictiveassessments of these issues is the major task to provide Risk based

Validation


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How to assess the risks

Step 1: Identify the hazards

Step 2: Decide what might be harmed and how

Step : Evaluate the risks and decide on precautions

Step 4: Record the findings and implement

Step 5: Review the assessment and update


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a hazard is anything that may cause harm, suchas chemicals, electricity, working from ladders,an open drawer etc.

the riskis the chance, high or low, thatsomebody could be harmed by these and otherhazards, together with an indication of howserious the harm could be.


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How the risk is determined

Hazard Identification, aims to determine the qualitativenature of the potential adverse consequences of thecontaminant (chemical, radiation, noise, etc.) and the

strength of the evidence it can have that effect.

Dose-Response Analysis, is determining the relationshipbetween dose and the probability or the incidence of effect(dose-response assessment).

Exposure Quantification, aims to determine the amount of acontaminant (dose) that individuals and populations willreceive.


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Risk Management Process


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Life Sciences Industry Framework


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Risk & Compliance Intelligence

Corporate Compliance & Governance

Pharmacovigilance

GXPs

Validation

Pre-Approval Safety Assessment


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What is Validation?

According to the Food and Drug Administration (FDA), the goal ofvalidation is to:

establish documented evidence which provides a high degree ofassurance that a specific process will consistently produce aproduct meeting its predetermined specifications and qualityattributes. [1]


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What is Validation?

What does this mean?

An quantitative approach is needed to prove quality,

functionality, and performance of apharmaceutical/biotechnological manufacturing process.

This approach will be applied to individual pieces of equipmentas well as the manufacturing process as a whole.

Guidelines for validation are set by the FDA, but the specifics ofvalidation are determined by the pharmaceutical/biotechcompany.


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To ensure your product, process, or service: is the best it can be

is the best on the market

always performs as expected

continues to grow and/or improve over time

Why Validation?


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Validation Process The V Model


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Validation Master Plan (VMP)

Project Validation Plan (PVP) User Requirements Specification (URS)

Functional Specifications (FS)

Design Specification (DS)

Design Qualification (DQ) Test Protocols

Installation Qualification (IQ)

Operation Qualification (OQ)

Performance Qualification (PQ)

Summary Report(s)

Validation Components


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VMP in the V-Model


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Validation Master Plan (VMP) Defined

Overarching procedural document Illustrates Company commitment to quality

Comprehensive overview of Facilities, Equipment,Processes, Automation, Procedures, & Methods Guide to how validation is performed one approach Defines project responsibilities Defines Validation goals

Description of all equipment, systems, procedures,etc. that fall within scope of validation

Describes approach company will take to identify allmatters that require validation oversight


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Project Validation Plan - PVP PVP is a:

Structured way to evaluate and communicate the necessaryvalidation elements of a complex project or system

Useful means for driving the project schedule Method for obtaining pre-approval for a lot of work throughstakeholders before investing a lot of time.

Meaningful tool that should be used on a value-added basis

VMP vs. PVP

VMP applies to all validation projects

PVP applies to a specific project


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User Requirements Specifications URS

The most critical document in the process

Purpose To formally document the requirements of a piece of equipment, a

system, or process so we can:

x Demonstrate we understand our processes

x Demonstrate we understand our products

x Demonstrate quality control

x

Ensure all stakeholders that have important knowledge about theprocesses and products are on the same page


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URS in the V-Model


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Types of URS Requirements

Functional - what you want a system to do

Non-functional - restrictions on the types of solutions that areneeded by the user to meet the functional requirements

Design objectives - guides to use in selecting a solution


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Functional URS Requirements

Types of behavior you want the system to perform

If you were buying vehicles for a factory your functionalrequirement might be: Must be able to transport a load from the warehouse to the assembly

building

Similarly for a computer system you define what the system is to

do: The system must store all details of a customer and their order.


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Non-Functional Requirements

Restrictions or constraints to be placed on the system and how tobuild it

Two Main Types of Constraints:

Performance Constraints

How the system should perform when it is delivered

Development Constraints

Project management attributes that can restrict the types of solutionthat can be offered. Three general types:

Time - When a system should be delivered? Resources - How much money is available to develop the system?

Invest time for business staff to brief development staff?

Quality- Any standards which are used to develop the system project management, methods, regulations, consensus standards, etc.


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URS Design Objectives

Become increasingly important during project development

They assist in selecting a solution from the number that areoffered to meet the requirements

Only the Owner knows what is the most important feature of anew system

Compromises are almost always necessary


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Phases of Validation

Validation is broken down into three phases:

x Installation Qualification (IQ)

x Operational Qualification (OQ)x Performance Qualification (PQ)

These three protocols are used to define tests that willdemonstrate that the process consistently and repeatedly

produces the desired product.


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Installation Qualification (IQ)

This is the first step in validation.

This protocol insures that the system/equipment and itscomponents are installed correctly and to the originalmanufacturers specifications.

Calibration of major equipment, accessory equipment, and/orutilities should be performed in this step as well.


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Operational Qualification (OQ)

This step proceeds after the IQ has been performed.

In the OQ, tests are performed on the critical parameters of thesystem/process. These are usually the independent and/ormanipulated variables associated with the system/equipment.

All tests data and measurements must be documented in order toset a baseline for the system/equipment.


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Performance Qualification (PQ)

This is the third and final phase of validation.

This phase tests the ability of the process to perform over longperiods of time within tolerance deemed acceptable.

PQ is performed on the manufacturing process as a whole.

Individual components of the system are not tested individually.


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Thank you

Documents

Risk Assessment in Life Sciences