GAMP and V-Model

Presented By :- Divya Mode Subject Incharge :- Dr. M. C. Damle

Mpharm QA (First Year) Subject :- Pharmaceutical Validation

II Sem
 Contents

1. Introduction

2. Purpose

3. History

4. Categories

5. Structure

6. Key concepts

7. V-Model

8. Applications

9. References
GAMP 5 Guidelines
• A Risk-Based Approach to Compliant GxP Computerized
Systems

• Latest released on July 2022

• At the ISPE Manufacturing Excellence Conference in Tampa,

Florida.

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 GAMP
INTRODUCTION :-

• GAMP stands for “Good Automated Manufacturing Practices”.

• It is a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE).

• GAMP is a set of guidelines for manufacturers and users of automated systems in the pharmaceutical
industry.

• More specifically, it is a set of principles and procedures that help ensure that pharmaceutical products have
the required quality.

• GAMP 5 Objective:
It aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements,
by building upon existing industry good practice in an efficient and effective manner.

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 PURPOSE
To provide a cost effective framework of
good practice to ensure that computerized
systems are fit for intended use and
compliant with applicable regulations

To provide framework which aims to

safeguard patient safety, product quality,
and data integrity, while also delivering
business benefit.

It also provides suppliers to the life science

industry with guidance on the development
and maintenance of systems by following
good practice.
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GAMP History :-

• GAMP (Good Automated Manufacturing Practice) was started in 1991 by a group of pharmaceutical
experts in the UK who wanted to meet the changing FDA expectations for GMP compliance of
manufacturing and related systems.

• They joined forces with ISPE (International Society for Pharmaceutical Engineering) as a “technical
sub-committee” and in 1995 released the first GAMP guidelines.

• GAMP 4, which was released in 2001, has been one of the standards GxP companies have been using
for computerized system validation for the last seven years.

• Today GAMP is a global organization which has “communities of practice” (COP) in Europe, Japan,
and the Americas.

• The GAMP guidance are accepted by regulators worldwide and referenced by the FDA and PIC/S in
their documents.

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 GAMP
Categories

Software Hardware

Category 1 Category 1
Infrastructure Standard
software hardware
Components
Category 3
Non-configured
products
Category 2
Category 4 Custom Built
Configured Hardware
products Components

Category 5
Custom
application 6
 GAMP documentation Structure :-

Appendices
GAMP • Management
5 Guide • Special Interest
Principles • Development
• Operation
and Framework
• General

Good Practice Guides Other Information

Laboratory
Global Information Systems • Papers and Articles
Process Controls • Templates and Examples
Infrastructure • Training Materials
Calibration
Management
Testing Electronic Data Archiving
Electronic Records and Signatures

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There are five key concepts to GAMP 5 :-

1. Product and Process Understanding

2. Lifecycle approach within QMS

3. Scalable Lifecycle Activities

4. Science Based Quality Risk Management

5. Leveraging Supplier Involvement

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1. Product and process understanding :-

• Understanding the product and process is critical in determining system requirements

and for making science and risk-based decisions to ensure that the system is "fit for use."

• In determining "fit for use," attention should be focused on "those aspects that are critical
to patient safety, product quality, and data integrity.

• Incomplete process understanding hinders effective and efficient compliance and

achievement of business benefit.

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2. Life Cycle Approach within a QMS:-
• Adopting a complete computerized system life cycle entails defining activities in a systematic
way from system concept and implementation through operation to retirement.

• The QMS should enable continuous process and system improvements based on periodic
review and evaluation, operational and performance data, and root-cause analysis of failures.

• Identified improvements and corrective actions should follow change management.

• A suitable life cycle, enables the assurance of quality and fitness for intended use, and
achieving and maintaining compliance with regulatory requirements.

• There are four major phases defined for any system:-

1. Concept 2. Project
3. Operation 4. Retirement

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3. Scalable Life Cycle Activities :-

• Life cycle activities should be scaled according to:-

 system impact on patient safety, product quality, and data integrity (Risk Assessment)

 system complexity and novelty (architecture and categorization of system components)

 outcome of supplier assessment (supplier capability)

• Business impact also may influence the scaling of life cycle activities. The strategy
should be clearly defined in a plan and follow established and approved policies and
procedures.

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4. Science Based Quality Risk Management :-

• Quality Risk Management is a systematic process for the assessment, control,

communication, and review of risks.

• Application of Quality Risk Management enables effort to be focused on critical aspects

of a computerized system in a controlled and justified manner.

• Quality Risk Management should be based on clear process understanding and potential
impact on patient safety, product quality, and data integrity.

• For systems controlling or monitoring CPPs, these should be traceable to CQAs, and
ultimately back to the relevant regulatory submissions for manufacturing systems.

• Qualitative or quantitative techniques may be used to identify and manage risks. Controls
are developed to reduce risks to an acceptable level.

• Risks that have been identified can be mitigated by:-

a. Elimination by design
b. Reduction to suitable level
c. Verification to demonstrate that the risks are managed to an acceptable level
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Quality Risk Management Process 14
5. Leveraging Supplier Involvement:-

• Regulated companies should seek to maximize supplier involvement throughout the system
life cycle in order to leverage knowledge, experience, and documentation, subject to
satisfactory supplier assessment.

• For example, the supplier may assist with requirements gathering, risk assessments, the
creation of functional and other specifications, system configuration, testing, support, and
maintenance.

• Planning should determine how best to use supplier documentation, including existing test
documentation, to avoid wasted effort and duplication.

• Justification for the use of supplier documentation should be provided by the satisfactory
outcome of supplier assessments, which may include supplier audits.

• Documentation should be assessed for suitability, accuracy, and completeness. There should
be flexibility regarding acceptable format, structure, and documentation practices.

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SOME APPLICATIONS OF GAMP-5:-

1. Monitoring manufacturing, production and storage environments in the

pharmaceutical industry.

2. Monitoring the autoclaving process in the pharmaceutical industry.

3. Water purification in the pharmaceutical industry.

4. Freeze drying in the pharmaceutical industry

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 V-Model
• The GAMP 5 V-model describes the activities to be performed and the deliverables to be produced
during product development. The name refers to the shape of its common graphical representation: a V.

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The GAMP 5 V-model strategy has a descending (planning, specification, configuration) and
ascending (configuration, verification, reporting) phase, going back and forth from the customer to
the supplier.

• First, in the descending phase, input from the customer helps the validation vendor implement the
requirements at the bottom of the V-model.

• Then, in the ascending phase, the resulting development is compared to the original input
statement to verify that the customer’s requirements have been met.

Eg.
• To demonstrate the implementation of GAMP5, we will use the GAMP V model. This model flows
from the top left to the top right with corresponding verification across the V. Implementing a
GAMP5 RTMS is broken down into 4 phases.

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 Phase 1

• The first portion of the V model covers the groundwork

needed to implement a RTMS, which the most important
step.

• Proper User Requirement Specification (URS) based on

science and quality risk management is done in this
phase.

• Once URS is develop it is supplied to vendor, they will

determine if the requirements are sufficient.

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 Phase 2

• During Phase 2 Functional Specifications(FS)

are developed using the HW and SW
specifications and the URS.

• FS to illustrate how the RTMS will operate and

be designed and configured.

• It will also show which HW and SW will be

used.

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 Phase 3

• Phase 3 demonstrates how to assemble your

system based on your URS and FS.

• Sensors, system modules, digital output

devices, serial to internet converters, software,
database configurations, all are put together.

• This phase is primarily vendor’s

responsibility.

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 Phase 4

• System is developed and internally tested

in this phase.

• During this phase, testing of system is

done. These tests include:-
 SAT
 IQ
 OQ
 PQ testing.

• These validate system as fit for use. All

testing should be traceable back to the
URS.

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REFERENCES
1. P. Lalasa & Vishal Gupta et.al., A Review on applications of GAMP - 5 in Pharmaceutical Industry,
International Journal of Drug Development and Research , July- September 2013, Vol. 5, Issue 3,
ISSN 0975-9344.

2. GAMP®5: A Risk-Based Approach to Compliant GMP Computerized Systems. Copyright ISPE

2008. Available at : www.ispe.org/publications/gamp4togamp5.pdf

3. ISPE GAMP-5 A Risk-Based Approach to Compliant GxP Computerized Systems, International

society for pharmaceutical engineering (ISPE), Fifth edition, Febrauary-2008, – applying
management based on the business process. Available at:
www.techstreet.com/products/preview/1559506

4. Charan H.Y, N. Vishal Singh; GAMP 5: A Quality Risk Management Approach to Computer
System Validation; International Journal of Pharmaceutical Sciences Review and Research; January
– February 2016; Article No. 34, Pages: 195-198; ISSN 0976 – 044X

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5. GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11;Amplelogic; Accessed on 22
April 2024.
https://amplelogic.com/gamp-5-categories-v-model-and-21-cfr-part-11-eu-annex-11/

6. What is gamp5 and the gamp v model?; Lighthouse worldwide solutions, technology; accessed on
22 april 2024.
https://www.golighthouse.com/en/knowledge-center/gamp5-gampv-model/

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