QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008
complete and detail study on the topic of validation used in pharmaceuticals industry and also in the learning purpose for the students in the classrooms. this ppt help a lot to the students as well as teachers to learn more on the validation topics.
PHARMACEUTICAL CALIBRATION & VALIDATION.
What is Validation?
What is calibration?
What are the types of Validation ?
Validation and calibration Basic Difference
Introduction to Pharmaceutical Validation, Scope & Merits of Validation, Validation and calibration of Master plan, Hrs ICH & WHO guidelines for calibration and validation of
equipment's, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
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.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
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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.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
2. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
IntroductionIntroduction
• Validation is an essential part of GMP, and an elementValidation is an essential part of GMP, and an element
of QAof QA
• Basic principles include:Basic principles include:
– Safety, quality and efficacy of productsSafety, quality and efficacy of products
– Built into the product – as it cannot be "inspected or testedBuilt into the product – as it cannot be "inspected or tested
into a product"into a product"
– Critical steps in the process need to be validatedCritical steps in the process need to be validated
• Need for confidence that the product will consistentlyNeed for confidence that the product will consistently
meet predetermined specifications and attributesmeet predetermined specifications and attributes
3. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Introduction (2)Introduction (2)
Documentation associated with validation:Documentation associated with validation:
• SOPsSOPs
• SpecificationsSpecifications
• Validation Master Plan (VMP)Validation Master Plan (VMP)
• Qualification protocols and reportsQualification protocols and reports
• Validation protocols and reportsValidation protocols and reports
4. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Introduction (3)Introduction (3)
Validation work requires considerable resources such as:Validation work requires considerable resources such as:
• Time:Time:
– work is subject to rigorous time scheduleswork is subject to rigorous time schedules
• Money:Money:
– may need specialized personnel and expensive technologymay need specialized personnel and expensive technology
• People:People:
– collaboration of experts from various disciplinescollaboration of experts from various disciplines
– a multidisciplinary team, comprising quality assurance,a multidisciplinary team, comprising quality assurance,
engineering, production, quality control (other disciplines,engineering, production, quality control (other disciplines,
depending on the product and process to be validated)depending on the product and process to be validated)
5. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Qualification and ValidationQualification and Validation
• Qualification and validation are essentially componentsQualification and validation are essentially components
of the same conceptof the same concept
• The termThe term qualificationqualification is normally used for equipment,is normally used for equipment,
utilities and systemsutilities and systems
• The termThe term validationvalidation is normally used for processesis normally used for processes
• In this sense, qualification is part of validationIn this sense, qualification is part of validation
6. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Validation: Approaches to validationValidation: Approaches to validation
• Two basic approaches:Two basic approaches:
1.1. Evidence obtained through testing (prospective andEvidence obtained through testing (prospective and
concurrent validation), andconcurrent validation), and
2.2. Analysis of accumulated (historical) dataAnalysis of accumulated (historical) data
(retrospective validation)(retrospective validation)
• Whenever possible, prospective validation is preferred.Whenever possible, prospective validation is preferred.
• Retrospective validation is no longer encouragedRetrospective validation is no longer encouraged
• Retrospective validation is not applicable to sterileRetrospective validation is not applicable to sterile
productsproducts
7. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Scope of validationScope of validation
• Validation requires an appropriate and sufficientValidation requires an appropriate and sufficient
infrastructure including:infrastructure including:
– organization,organization, documentation, personneldocumentation, personnel and financesand finances
• Involvement of management and quality assuranceInvolvement of management and quality assurance
personnelpersonnel
• Personnel with appropriate qualifications andPersonnel with appropriate qualifications and
experienceexperience
• Extensive preparation and planning before validation isExtensive preparation and planning before validation is
performedperformed
• A specific programme for validation activities in placeA specific programme for validation activities in place
• Validation done in a structured way according toValidation done in a structured way according to
documentation including procedures and protocols.documentation including procedures and protocols.
8. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Scope of validation (2)Scope of validation (2)
• Validation should be performed:Validation should be performed:
– for new premises, equipment, utilities and systems, andfor new premises, equipment, utilities and systems, and
processes and procedures;processes and procedures;
– at periodic intervals; andat periodic intervals; and
– when major changes have been made.when major changes have been made.
• Validation in accordance with written protocols.Validation in accordance with written protocols.
• A written report on the outcome to be produced.A written report on the outcome to be produced.
• Validation over a period of time, e.g.Validation over a period of time, e.g.
– at least three consecutive batches (full production scale) toat least three consecutive batches (full production scale) to
demonstrate consistency. (Worst case situations should bedemonstrate consistency. (Worst case situations should be
considered.)considered.)
9. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Scope of validation (3)Scope of validation (3)
• Demonstrate suitability for new manufacturing formulaDemonstrate suitability for new manufacturing formula
or methodor method
• Process, materials and equipment to prove consistentProcess, materials and equipment to prove consistent
yield of a product of the required qualityyield of a product of the required quality
• Significant changes (facilities, equipment, processes) -Significant changes (facilities, equipment, processes) -
should be validatedshould be validated
• Risk assessment approach used to determine the scopeRisk assessment approach used to determine the scope
and extent of validation neededand extent of validation needed
10. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
QualificationQualification
• Qualification should be completed before processQualification should be completed before process
validation is performedvalidation is performed
• A logical, systematic process followedA logical, systematic process followed
• Start from the design phase of the premises, equipment,Start from the design phase of the premises, equipment,
utilities and equipmentutilities and equipment
• Major equipment and critical utilities and systemsMajor equipment and critical utilities and systems
normally require IQ, OQ and PQnormally require IQ, OQ and PQ
11. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Qualification (2)Qualification (2)
• Some equipment, utilities and systems require only IQSome equipment, utilities and systems require only IQ
and OQ as the correct operation could be consideredand OQ as the correct operation could be considered
to be a sufficient indicator of its performanceto be a sufficient indicator of its performance
• The equipment, utility and system should then beThe equipment, utility and system should then be
maintained, monitored and calibrated according to amaintained, monitored and calibrated according to a
regular scheduleregular schedule
13. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Validation Master Plan (VMP)Validation Master Plan (VMP)
• Contains key elements of the validation programme.Contains key elements of the validation programme.
• Concise, clear, contain at least:Concise, clear, contain at least:
– a validation policya validation policy
– organizational structure of validation activitiesorganizational structure of validation activities
– summary of facilities, systems, equipment and processessummary of facilities, systems, equipment and processes
validated (and to be validated)validated (and to be validated)
– documentation format (e.g. protocol and report)documentation format (e.g. protocol and report)
– planning and schedulingplanning and scheduling
– change control and references to existing documentschange control and references to existing documents
14. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Qualification and validation protocolsQualification and validation protocols
• Describe the study to be performed:Describe the study to be performed:
– the objectives of the studythe objectives of the study
– the site of the studythe site of the study
– the responsible personnelthe responsible personnel
– description of SOPs to be followeddescription of SOPs to be followed
– equipment to be usedequipment to be used
– standards and criteria for the products and processesstandards and criteria for the products and processes
15. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Qualification and validation protocols (2)Qualification and validation protocols (2)
• Protocol contents (2):Protocol contents (2):
– the processes and/or parametersthe processes and/or parameters
– sampling, testing and monitoring requirementssampling, testing and monitoring requirements
– predetermined acceptance criteria for drawing conclusionspredetermined acceptance criteria for drawing conclusions
• Description (how results will be analyzed)Description (how results will be analyzed)
• Protocol approved prior to use - changes approvedProtocol approved prior to use - changes approved
prior to implementation of the changeprior to implementation of the change
16. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Qualification and validation reportsQualification and validation reports
• Written reports on the qualification and validationWritten reports on the qualification and validation
performedperformed
• Reflect protocols followed and include at least:Reflect protocols followed and include at least:
– title and objective of the study; reference to the protocol; detailstitle and objective of the study; reference to the protocol; details
of materialof material
– equipment, programmes and cycles used; procedures and testequipment, programmes and cycles used; procedures and test
methodsmethods
• Results evaluated, analyzed and compared against theResults evaluated, analyzed and compared against the
pre-determined acceptance criteriapre-determined acceptance criteria
17. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Qualification and validation reports (2)Qualification and validation reports (2)
• The results should meet the acceptance criteriaThe results should meet the acceptance criteria
• Deviations and out-of-limit results should beDeviations and out-of-limit results should be
investigated. If these are accepted, this should beinvestigated. If these are accepted, this should be
justified. Where necessary further studies should bejustified. Where necessary further studies should be
performedperformed
• Responsible departments and QA to approveResponsible departments and QA to approve
completed report, including the conclusioncompleted report, including the conclusion
18. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Qualification stagesQualification stages
• There are four stages of qualification:There are four stages of qualification:
– design qualification (DQ);design qualification (DQ);
– installation qualification (IQ);installation qualification (IQ);
– operational qualification (OQ); andoperational qualification (OQ); and
– performance qualification (PQ).performance qualification (PQ).
• All SOPs for operation, maintenance and calibrationAll SOPs for operation, maintenance and calibration
should be prepared during qualificationshould be prepared during qualification
• Training provided and records maintainedTraining provided and records maintained
19. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Design qualificationDesign qualification: Provides documented evidence: Provides documented evidence
that the design specifications were metthat the design specifications were met
Installation qualificationInstallation qualification: Provides documented: Provides documented
evidence that the installation was complete andevidence that the installation was complete and
satisfactorysatisfactory
• During IQ:During IQ:
– Purchase specifications, drawings, manuals, spare parts listsPurchase specifications, drawings, manuals, spare parts lists
and vendor details should be verifiedand vendor details should be verified
– Control and measuring devices should be calibratedControl and measuring devices should be calibrated
20. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Operational qualificationOperational qualification: Provides documented: Provides documented
evidence that utilities, systems or equipment and all itsevidence that utilities, systems or equipment and all its
components operate in accordance with operationalcomponents operate in accordance with operational
specificationsspecifications
• Demonstrate satisfactory operation over the normalDemonstrate satisfactory operation over the normal
operating range as well as at the limits of its operatingoperating range as well as at the limits of its operating
conditions (including worst case conditions)conditions (including worst case conditions)
• Operation controls, alarms, switches, displays and otherOperation controls, alarms, switches, displays and other
operational components should be testedoperational components should be tested
21. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Performance qualificationPerformance qualification: Provides documented: Provides documented
evidence that utilities, systems or equipment and all itsevidence that utilities, systems or equipment and all its
components can consistently perform in accordancecomponents can consistently perform in accordance
with the specifications under routine usewith the specifications under routine use
• Test results collected over a suitable period of time toTest results collected over a suitable period of time to
prove consistencyprove consistency
22. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
RequalificationRequalification
• In accordance with a defined scheduleIn accordance with a defined schedule
• Frequency to be determined (e.g. on the basis of factorsFrequency to be determined (e.g. on the basis of factors
such as the analysis of results relating to calibration,such as the analysis of results relating to calibration,
verification and maintenance)verification and maintenance)
• Periodic and after changesPeriodic and after changes
– e.g. changes to utilities, systems, equipment; maintenancee.g. changes to utilities, systems, equipment; maintenance
work; and movementwork; and movement
• Part of change control procedurePart of change control procedure
23. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
RevalidationRevalidation
• Processes and procedures - to ensure that they remainProcesses and procedures - to ensure that they remain
capable of achieving the intended resultscapable of achieving the intended results
• Periodic revalidation, as well as revalidation afterPeriodic revalidation, as well as revalidation after
changeschanges
• In accordance with a defined scheduleIn accordance with a defined schedule
• Frequency and extent determined using a risk-basedFrequency and extent determined using a risk-based
approach together with a review of historical dataapproach together with a review of historical data
24. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Periodic revalidationPeriodic revalidation
• To assess process changes that may occur graduallyTo assess process changes that may occur gradually
over a period of time, or because of wear of equipmentover a period of time, or because of wear of equipment
• Consideration given to:Consideration given to:
– master formulae and specificationsmaster formulae and specifications
– SOPsSOPs
– records (e.g. of calibration, maintenance and cleaning)records (e.g. of calibration, maintenance and cleaning)
– analytical methodsanalytical methods
25. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Revalidation after changeRevalidation after change
• After change that could have an effect on the process,After change that could have an effect on the process,
procedure, quality of the product and/or the productprocedure, quality of the product and/or the product
characteristics. (Considered as part of the changecharacteristics. (Considered as part of the change
control procedure.)control procedure.)
• Extent depends on the nature and significance of theExtent depends on the nature and significance of the
change(s)change(s)
• Changes should not adversely affect product quality orChanges should not adversely affect product quality or
process characteristicsprocess characteristics
26. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Revalidation after change (continuation)Revalidation after change (continuation)
• Changes of equipment which involve the replacementChanges of equipment which involve the replacement
of equipment on a “like-for-like” basis would notof equipment on a “like-for-like” basis would not
normally require a revalidationnormally require a revalidation
• For example, installation of a new centrifugal pump toFor example, installation of a new centrifugal pump to
replace an older model wouldreplace an older model would not necessarily requirenot necessarily require
revalidationrevalidation
27. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
Change controlChange control
• SOP followed - as changes may have an impact on aSOP followed - as changes may have an impact on a
qualified utility, system or piece of equipment, and aqualified utility, system or piece of equipment, and a
validated process and/or procedurevalidated process and/or procedure
• Describe the actions to be taken, including the need forDescribe the actions to be taken, including the need for
and extent of qualification or validationand extent of qualification or validation
• Changes should be formally requested, documentedChanges should be formally requested, documented
and approved before implementationand approved before implementation
• Records should be maintainedRecords should be maintained
28. QUALIFICATION & VALIDATIONQUALIFICATION & VALIDATION
PersonnelPersonnel
• Demonstrate that personnel are appropriately qualified,Demonstrate that personnel are appropriately qualified,
where relevantwhere relevant
• These include for example:These include for example:
– laboratory analysts;laboratory analysts;
– personnel following critical procedures;personnel following critical procedures;
– personnel doing data entry in computerized systems; andpersonnel doing data entry in computerized systems; and
– risk assessors.risk assessors.