GAMP 5 provides guidance for computerized systems validation. It focuses on risk-based approaches and scalability of efforts based on a system's risk, complexity, and novelty. GAMP 5 also emphasizes leveraging supplier activities and avoiding duplication of efforts. The document provides a framework for life cycle activities from concept to retirement, including planning, specification, development, operation, and retirement of computerized systems.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
This presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
Pharmaceutical Quality Management System describes the framework of planning, organizing, controlling and monitoring of activities throughout product life cycle. This presentation briefly describes the fabric of QMS which provides the foundation of quality products.
This presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
Pharmaceutical Quality Management System describes the framework of planning, organizing, controlling and monitoring of activities throughout product life cycle. This presentation briefly describes the fabric of QMS which provides the foundation of quality products.
Embedding GAMP Compliance into Digital Health Software - The Case of SpiraPlanInflectra
In this presentation, Dr. Sriram Rajagopalan of Inflectra covers the fundamentals of integrating GAMP compliance into digital health software. The presentation covers the Risk-Based Approach to Compliance for GxP Computerized Systems.
Enjoy.
Functional testing addresses particular aspect of the user experience, accessibility, and performance, so when your users receive the app's final version, they can be sure that it works seamlessly. Functional Testing is an essential aspect of application development and helps ensure the app that you are building is stable and works well
The functional or requirement specifications help define what QA engineers consider acceptable while running functional tests. These specifications are a document that tells the QA engineers what actions they must take to determine the conformance of the software system. This document can also ask them to run tests on specific business side scenarios for an overall system picture.
Hence, we understand that QA engineers can carry out functional testing in two ways:
- Requirements-based functional testing: This method contains instructions on validating the software system's functional aspects.
- Business scenarios-based functional testing: This method contains instructions on validating the software system based on business scenarios.
Functional testing is software testing that ensures a software system works according to its given specifications. This test's primary goal is to test the functional aspects of the application's software by providing the input and verifying the output based on requirements.
This test does not concern itself with the application's source code and mainly involves black box testing. It checks the APIs, security, client/server communication, database, UI, and other application functionalities. Testers can run functional tests either by using automation or manually.
What do you test in Functional Testing?
Testers primarily run functional testing to check the software system's functionalities. The areas this testing concentrates on are:
- Accessibility: Runs accessibility checks on the system to see if it meets accessibility requirements.
- Error Conditions: Whenever there is an error, the system usually provides a valuable error message. This test validates that your system works well and provides the appropriate error messages to debug.
- Mainline functions: The system has no value if its main functions do not work well. This testing runs to ensure this does not happen.
- Basic Usability: The test runs a usability test to ensure that users navigating your system can do so seamlessly.
The Different Functional Testing Types
- Unit Testing
- Smoke Tests
- Sanity Tests
- Regression Tests
- Integration Tests
- Usability Testing
Functional testing generally follows the steps mentioned below:
- Determine which aspect of the software system the testers need to test. These aspects or functionalities can vary from error conditions, product usability, messages, or central functions.
- Create input data according to specific requirements for the functionalities that need testing.
- Based on the outlined requirements, determine which output parameters are acceptable and which ones are not.
- Execute test cases.
- Finally, compare the expected output with the actual result you receive from the test. Tracking this will reveal if your software system works well.
This ppt contains ISPE guidelines for Pharmaceutical Engineering, activities in Good Engineering Practices, Risk Management in GEP, Cost Management in GEP, ISPE guide for GEP, SOP in GEP, project engineering,Change Management IN GEP.
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation.
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.
Software validation do's and dont's may 2013John Cachat
Software validation is often times a very misunderstood concept. For FDA regulated industries, there are clear expectations including “the least burdensome approach.” Validation alone does not guarantee software quality—many other aspects of software engineering are required.
Join software expert, John Cachat, as he discusses how to solve several software validation issues, including:
Requirements
Defect Prevention
Time and Effort
Software Life Cycle
Plans
Procedures
Software Validation After a Change
Validation Coverage
Independence of Review
Flexibility and Responsibility
A regression testing approach is needed to evaluate the overall working of the application after it has undergone a recent change.
- Examines the functionality of the upgrade
- Ensures that the change does not interfere with existing features
- Identifies any errors or bugs in the application's existing functionalities
- It helps determine bugs in the newly pushed code
## Strategy for regression testing - what to test, how often, and more
Regression testing strategy depends on several key factors, like how often developers upgrade the application, how significant the new change is, and what existing sections it could affect.
Here are some tried and tested proven strategies that you could follow during regression testing:
- Measure or change the scale of the upgrade to determine how likely it would affect the application.
- When introducing automation testing, outline the test cases and scenarios to know which should be automated and manually tested.
- The regression testing approach must cover all the possible test cases and impacted functionalities.
- Focus on the testing process, technology, and roles when automating regression testing
- Perform risk analysis based on the size of your business/project and its complexity, along with its importance
## Tips for managing regression risks
- Proactively identify and assess regression risks before starting the regression testing process. You can then focus all your efforts on the most critical areas.
- Use risk mitigation strategies to reduce the impact of identified risks. For example, if a particular threat could result in data loss, you could create backups to mitigate the risk.
- Use a structured approach for managing regression risks, such as a risk registry or risk management plan; this will help ensure that all threats are captured and tracked.
- Communicate any potential impacts of regression risks to stakeholders to make informed decisions about the release schedule.
## Steps to perform regression testing:
- Prepare for manual and automated tests: This involves getting the required tools and resources ready, such as test data, test cases, test scripts, and more.
- Identify which changes or upgrades on existing modules of the application will impact its functionalities: You need to specifically identify which areas of the application will be affected by the changes or upgrades to focus your testing efforts during regression testing on those areas.
- Use manual and automated tests accordingly: Once you have identified the impacted functionalities, you can use both manual and automation tests to validate that the changes or upgrades have not adversely affected those functionalities.
Some of the most common regressions that need testing include functionalities such as login, search, and checkout. To detect these regressions, you can use different methods such as checking the application's output against expected results, performing functional tests, and using automated tools.
NERC CIP - Top Testing & Compliance Challenges, How to Address ThemInflectra
The North American Electric Reliability Corporation's (NERC) Critical Infrastructure Protection plan is a set of requirements designed to secure the assets required for operating North America's bulk electric system. In this webinar, we will discuss the key challenges in testing and compliance with NERC-CIP and highlight best practices to comprehensively address these challenges. We will dedicate a portion of our conversation to discussing the tools and technology that can help increase the effectiveness of your NERC-CIP compliance efforts.
NIST RMF has over 900+ controls and each control has many sub-requirements, most security officers do not like this framework due to its high level of complexity compared to other frameworks. Ignyte assurance platform operationalizes all six steps of the NIST RMF to get you to ATO faster.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
3. INTRODUCTION
GAMP 5 leverages risk management from GAMP 4 and
addresses the entire lifecycle of automated systems
The biggest change being to provide more clearly defined
scalability for effort / deliverables versus the size /
complexity of projects, and to align with the various
regulatory bodies’ emphasis on risk / science-based GxPs.
GAMP 5 aligns with major industry developments including
PQLI1, ICH Q8, Q9, Q10, and ASTM E2500 and points to
the future of computer systems compliance
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4. INTRODUCTION…
GAMP 5 is applicable to a wide range of information
systems, lab equipment, integrated manufacturing systems,
and IT infrastructures
After over 4 years of re-work GAMP 5 was released in Feb
2008,and is a major rewrite of GAMP 4 with significant
changes having as primary goals:
Bringing procedures in line with the dynamic Life science
industry
reducing the cost of compliance
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5. Coupled to this there is the need to:
Avoid duplication of activities (e.g. by fully integrating engineering and
computer system activities so that they are only performed once)
Leverage supplier activities to the maximum possible extent, while still
ensuring fitness for intended use.
Scale all life cycle activities and associated documentation according to
risk, complexity and novelty.
Recognise that most computerised systems are now based on
configurable packages, many of them networked.
Acknowledge that traditional linear or waterfall development models are
not the most appropriate in all cases.
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9. Few of the Important Points:
GAMP 5 is not prescriptive. All lifecycle activities and associated documentation
are to be scaled according to risk, complexity, novelty. (Some examples):
• Risk: manufacturing process control = high risk, database containing
training records = low risk
• Complexity: SAP = high complexity, Excel spreadsheet calculating lab
results = low complexity.
• Novelty: Excel = used by millions worldwide, lab instrument PC
software = used by thousands worldwide, in-house developed
application - used only by the company that developed it.
GAMP 5 - all about risk. Increasing complexity and/or novelty = higher risk =
more effort and deliverables.
Moving away from traditional qualification terminology (e.g. IQ, OQ, PQ).
Terminology confuses people outside of the validation and QA departments.
Terminology is still available, but optional.
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10. Few of the Important Points. . .
Most computerized systems now based on configurable packages, many of
them networked.
Validate only if there could be an impact on patient safety, product quality,
data integrity. If none of these, no need to validate, good engineering
practice is sufficient.
Need to be clear on the differences between system owner and process
owner.
QA less involved than in the past. For example QA should review a URS
against the applicable regulations. URS technical review is for technical
subject matter experts. QA does not need to sign a design spec, as they do
not understand it.QA can verify that design specs are being produced for
projects but QA does not need to sign every document in a project.
GAMP 5 approach is consistent with ASTM E2500-07 Standard Guide for
Specification, Design, and Verification of Pharmaceutical and
Biopharmaceutical Manufacturing Systems and Equipment.
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11. LIFE CYCLE APPROACH
It entails defining and performing activities in a systematic way from conception,
understanding requirements, through development, release & operational use to
system requirement
Specification, Design and verification Process
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13. QUALITY RISK MANAGEMENT
It is a systematic process for the assessment, control,
communication & review of risk.
It is an iterative process used throughout the entire
computerized system life cycle from concept to retirement.
For a given organization, a framework for making risk
management decisions should be defined to ensure
consistency of application across systems and business
functions.
Terminology should be agreed upon, particularly regarding
definitions and metrics for key risk factors.
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16. RELATIONSHIP OF RISK,SEVERITY AND CONTROL
Effect on High Risk Priority
•Patient safety Use risk
•Data integrity assessment to
identify specific
controls and
rigor
Medium Risk
Priority
Use generic
checklist controls
Low Risk Priority
Use “Good
practice”
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17. SCIENCE BASED QUALITY RISK MANAGEMENT
Determining the risks posed by a computerized system
requires a common and shared understanding of:
Impact of the computerized system on patient safety, product
quality and data integrity
Supported business processes
CQA (Critical Quality Attributes) for systems that monitor or
control CPP (Critical Process parameters)
User requirements
Regulatory requirements
Project approach
System components and architecture
System functions
Supplier capability
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18. SCIENCE BASED QUALITY RISK MANAGEMENT…
Managing the risks may be achieved by:
Elimination by Design [EbD]
Reduction to an acceptable level
Verification to demonstrate that risks are managed
to an acceptable level
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19. Quality Risk Management Process
The ICH Guideline ICH Q9 describes a systematic approach to
quality risk management intended for general application within
pharmaceutical industry
It defines following two primary principles of quality risk
management
1.The evaluation of risk to quality should be based on scientific
knowledge and ultimately link to the protection of the patient.
2.The level of effort, formality and documentation of the quality
risk management process should be commensurate with the
level of risk.
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20. Quality Risk Management Process
• QRM structured according to
ICH Q9 & ISPE Guide
• Starts with system impact
• Including FMEA [Failure
Mode and Effects Analysis]
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22. GAMP CATEGORY
1
DIFFERENCE BETWEEN GAMP 4 AND GAMP 5
OPERATING INFRASTRUCTURE
SYSTEMS[GAMP-4] SOFTWARE[GAMP-5]
Only Operating Expanded greatly to
systems included cover established or
commercially available
layered software and
infrastructure software
tools
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23. GAMP CATEGORY
2
DIFFERENCE BETWEEN GAMP 4 AND GAMP 5…
FIRMWARE FIRMWARE
[GAMP-4] [GAMP-5]
Configurable and Discontinued-
non-configurable firmware is now
firmware only. treated as software
Custom firmware is in one of
Category 5 categories 3,4 or 5.
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24. GAMP CATEGORY
3
DIFFERENCE BETWEEN GAMP 4 AND GAMP 5…
STANDARD NON-CONFIGURED
SOFTWARE PRODUCTS[GAMP-5]
PACKAGES[GAMP-4]
Off-the-shelf products
Commercially available used for business
standard software processes, as well as
packages. those that are
Configuration limited configurable, but for
to establishing the which only the default
run-time environment configuration is used
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25. GAMP CATEGORY
4
DIFFERENCE BETWEEN GAMP 4 AND GAMP 5…
CONFIGURABLE CONFIGURED
SOFTWARE PRODUCTS[GAMP-5]
PACKAGES[GAMP-4]
Configured products
Configurable software provide standard
packages provide interfaces and functions
standard interfaces and that enable configuration
functions that enable of the application to
configuration of user- meet user specific
specific business or business processes.
manufacturing processes Configuration using a
vendor-supplied
language should be
handled as custom
components
(Category 5)
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26. GAMP CATEGORY
5
DIFFERENCE BETWEEN GAMP 4 AND GAMP 5…
CUSTOM (BESPOKE) CUSTOM
SOFTWARE[GAMP-4] APPLICATIONS
[GAMP-5]
These systems are These systems or
developed to meet the subsystems are
specific needs of the developed to meet the
user company specific needs of the
regulated company.
Inherent risk is high
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27. Regulated Company Activities
This involves activities at both the
organizational level and at the level of
individual system, therefore this section is
divided into..
1. Governance for achieving compliance
2. System specific activities
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28. 1.Governance for achieving compliance
ACTIVITIES…
Establishing computerized systems compliance
policies and procedures
Identifying clear roles and responsibilities
Training
Managing supplier relationships
Maintaining a system inventory
Planning for validation
Continuous improvement activities
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29. 2.System Specific Activities
ACTIVITIES…
Identify compliance standards
Identify system
User requirement specification
Determine strategy for achieving compliance and fitness for
intended use
Planning
System specifications
Development and review of software for custom applications
Test strategy and testing
Reporting and release
Maintaining system compliance during operation
System retirement
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30. Supplier Activities
Supplier products, applications and services
Supplier good practices
Quality management system
Requirements
Supplier Quality Planning
Sub-supplier assessments
Specifications
Design reviews
Software production/configuration
Testing
Commercial release
User documentation and training
System support and maintenance during operation
System replacement and retirement
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31. EFFICIENCY IMPROVEMENTS
Establishing verifiable and objective user
requirements
Use of risk based decisions
Leveraging supplier input
Leveraging existing documentation
Efficient testing practice
Well managed handover
Efficient change management
Anticipating data archiving and migration needs
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34. Critical Process Parameters (CPP’s)
“Process parameters whose variability impact a quality
attribute and therefore need to be controlled to ensure the
process produces the desired quality…….. and have an
effect on the CQA(s) of the drug substance or drug
product.”
A CPP remains critical even if it is controlled.
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35. Critical Quality Attributes (CQA’s)
“Physical, chemical, biological or microbiological
properties or characteristics that need to be controlled
(directly or indirectly) to ensure product quality.
(i.e. dissolution, potency, homogeneity, purity)”
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36. ASTM E2500
[American Standard for Testing Materials]
Provides a
Risk / Science Based Approach
for
Specification, Design & Verification
of
Manufacturing Systems and Equipment
using
Systematic, Efficient & Effective Methods
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37. LIFE CYCLE PHASE: CONCEPT
During concept phase, the regulated company
considers opportunities to automate one or more
business processes based upon business need and
benefits.
At this phase initial requirements will be developed
and potential solutions considered.
From initial understanding of scope, costs and
benefits, a decision is made on whether to proceed
to the project phase.
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38. LIFE CYCLE PHASE: PROJECT
The project phase involves…
planning,
supplier assessment & selection ,
various levels of specification,
configuration (or coding for custom applications) and
verification leading to acceptance and release for
operation.
Risk management is applied…
to identify risks and
to remove or reduce them to an acceptable level.
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39. LIFE CYCLE PHASE: OPERATION
System operation, typically, is the longest phase and is
managed by..
the use of defined, up to date, operational procedures
applied by..
personnel who have appropriate training, education and
experience.
key aspects :
Maintaining control (including security),
fitness for intended use and
compliance
important activity:
The management of changes of different impact, scope and
complexity.
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40. LIFE CYCLE PHASE: RETIREMENT
It involves decisions about…
Data retention,
Migration or destruction and
The management of this processes
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41. ICH: International Conference on Harmonisation of technical
Requirements for Registration of Pharmaceuticals
for Human Use
ICH Q-Documents
Q1 Stability
Q2 Analytical Validation
Q3 Impurities
Q4 Pharmacopoeias
Q5 Quality of Biotechnological Products
Q6 Specifications
Q7 Good Manufacturing Practice
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality Systems
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42. Pharmaceutical Development (Q8)
Past: Data transfer / Variable output
Present: Knowledge transfer / Science
based / Consistent output
Quality Risk Management (Q9)
Past: Used, however poorly defined
Present: Opportunity to use structured
process thinking
Pharmaceutical Quality Systems (Q10)
Past: GMP checklist
Future: Quality Systems across product
life cycle
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43. HACCP:
Hazard Analysis and Critical Control
Points
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44. PQLI
Physical Quality of Life Index
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45. ISPE:
International Society for
Pharmaceutical Engineering
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48. PLANNING
Planning should cover all required activities, responsibilities,
procedures and timeline
PLANNING • Activities should be scaled according to:
HIERARCHY
o System impact on patient safety, product
MULTI-SITE quality and data integrity (risk assessment)
o System complexity and novelty (Architecture
and categorization of system components)
SITE
o Outcome of supplier assessment Supplier
capability )
• User requirements are the responsibility
DEPARTMENT
of the user community and should be
OR AREA
maintained and controlled
• Approach should be based on product
and process understanding and relevant
SYSTEM regulatory requirements
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49. SPECIFICATION
The role of specification is to enable systems to be
developed, verified and maintained
The number and level of the detail of the
specifications will vary depending upon type of system
and its intended use
Before use ,regulated company should ensure that
they are adequate to support subsequent activities,
including risk assessment, further specification and
development of the system, and verification as
appropriate
Specification may be available from supplier
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50. CONFIGURATION AND CODING
The requirements for configuration and coding
activities depend on the type of the system
Any required configuration should be performed in
accordance with a controlled and repeatable
process
The need for code reviews should be addressed as
part of risk management
Configuration management is an intrinsic and vital
aspect of controlled configuration and coding
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51. VERIFICATION
Verification confirms that specifications have been met
This may involve multiple stages of reviews and testing
depending on the type of system, the development method
applied, and its use
Testing computerized systems is a fundamental verification
activity
Testing often is performed at several levels depending on the
risk, complexity and novelty
There is a range of different types of testing possible
including normal case (positive), invalid case (negative),
repeatability, performance, volume/load, regression and
structural testing
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52. REPORTING
Acceptance and release of the system for use in GxP
regulated activities should require the approval of…
the process owner,
system owner,
quality unit representatives
At the conclusion of the project, a computerized system
validation report should be produced summarizing…
the activities performed,
any deviations from the plan ,
any outstanding and corrective actions,
providing a statement of fitness for intended use of the
system
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