Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
OOS and OOT investigation is always a challenging task. This slide may help for a better understanding of investigation procedure according to regulatory requrement.
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
OOS and OOT investigation is always a challenging task. This slide may help for a better understanding of investigation procedure according to regulatory requrement.
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
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.
vendor validation is important now a days in pharmaceutical industries.
vendor is authorizes seller of raw material,equipment and packaging material to the pharmaceutical organization.
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.
vendor validation is important now a days in pharmaceutical industries.
vendor is authorizes seller of raw material,equipment and packaging material to the pharmaceutical organization.
The requirements for supplying/purchasing material for Code stamped pressure
vessels within the nuclear industry are not always apparent.
This paper explains how the types of materials may be furnished by different entities with simple diagrams, rather than complex paragraphs.
Sourcing Success - How to Find a Clothing ManufacturerWave PLM
This presentation will provide you with the insights and tools needed to find and maintain a fruitful partnership with the right clothing manufacturer.
The Impact of BRC Food 7: Most Common Non-ConformitiesTraceGains
The 7th issue of the BRC Global Standard for Food Safety began audits July 1, 2015, and we now have almost 2 months’ worth of results. The information coming back paints a picture of readiness of sites for the changes, and a picture of what they have had to prepare for successful continuation of certification is forming.
The session will cover the most significant changes the 7th issue brought forward, why they were included, what BRC expected, and what impact the changes are actually having on the industry.
Specifically, the session will focus on:
-The top non-conformities seen in issue 7 audits
-Strategies for your operation to learn from these early audits
-What changes have been made, and why they make the BRC Global Standards the leading certification for food safety.
BRC is the leading and most recognized of the GFSI benchmarked programs, and is used at manufacturing sites, and by customers as a leading certification around the world. John Kukoly, our presenter, is the head of BRC activities in the Americas.
Auditing a vendor is truly an essential part of QMS. This presentation describes the terminologies used in vendor Audit & the way of selection, routine audi7 & approval procedure as per authority or institutional rules.
Thanks
Define, select, and apply various techniques including supplier qualification, certification, evaluation, ratings, performance
improvement, and so on.
The #DROOS_FLGAWDA channel is dedicated to providing scientific content that effectively contributes to building knowledge among interested and quality workers as well as manufacturers and service providers so that they can achieve their products better, faster and at the lowest cost.
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GMP Sub Part - "E" gives valuable information regarding Control of components and Product containers and closures during pharmaceutical manufacturing while Sub Part - "F" gives ideas about pharmaceutical production and process control. Very helpful to pharma professionals.
This is a copy of a presentation I made recently at the CALCE counterfeit symposium at the University of Maryland. It addresses avoiding counterfeit parts in the open market.
Paragon Scientific Ltd. Founded in 1994, we have developed an international reputation synonymous with quality, prompt delivery,
affordability and first class customer service. We are committed to develop, manufacture and supply the highest quality standards and reference materials available in the marketplace. We believe that this approach combined with key attention to customer service, technical support and prompt delivery is key to our business success.
Good pipetting technique helps scientists achieve more reliable results from their experiments. Nothing is more frustrating than having to repeat an experiment because poor pipetting technique offset the accuracy of aspirated volumes by 10-50%. Good pipetting technique may also help avoid embarrassing retractions of manuscripts from journals after peers fail to replicate an experiment. Proper pipette technique not only improves experimental outcomes, but it also helps protect the scientist from injury resulting from poor micropipette technique. As proper pipetting technique encompasses the use of ergonomic pipettes, this can also translate to a long-lasting investment for your laboratory. By choosing CAPP’s range of ergonomic pipettes labs have the benefit of long-lasting and robust tools that can be used for a very long time. When coupled with the use of CAPP’s premium filter tips and pipette cone filters that protect pipette shafts from potentially harmful splashes, good pipette technique will save on the cost of equipment replacement.
KF Titrandos' modularity provides it significant flexibility and customization. For example, this KF titrator series contains a variety of coulometric, volumetric, and combination titrators, allowing you to analyse any water content ranging from 0.001 to 100%.
KF Titrandos can be used as standalone titrators or as part of a larger network. The operation has been optimised for both scenarios: you can tap the full power of your Titrando system by using a handy Touch Control unit, the sophisticated tiamo software, or the current OMNIS software.
You also don't have to worry about assembling your titrator, electrode, sample changer, and accessories. We provide all-inclusive packages that include everything you need for a particular application.
Animals secrete pheromones to trigger many types of behaviors, including:
raising an alarm
signaling a food trail
triggering sexual arousal
tell other female insects to lay their eggs elsewhere
delineating a territory
bond between mother and offspring
warning another animal to back off
Nitric oxide supplements are a category of supplements that includes L-citrulline and L-arginine. Researchers have performed multiple clinical trials related to nitric oxide supplements and their effectiveness, often with mixed results.
Mitochondrial biogenesis is the process by which cells increase mitochondrial numbers. It was first described by John Holloszy in the 1960s, when it was discovered that physical endurance training induced higher mitochondrial content levels, leading to greater glucose uptake by muscles. Mitochondrial biogenesis is activated by numerous different signals during times of cellular stress or in response to environmental stimuli, such as aerobic exercise.
Melatonin is a hormone made in the body. It regulates night and day cycles or sleep-wake cycles. Melatonin in supplements is usually made in a lab.
Darkness triggers the body to make more melatonin, which signals the body to sleep. Light decreases melatonin production and signals the body to be awake. Some people who have trouble sleeping have low levels of melatonin. It's thought that adding melatonin from supplements might help them sleep.
Ion channels have many features of typical membrane proteins. They are synthesized and inserted into the membrane of the endoplasmic reticulum, glycosylated in the Golgi, and transported and inserted into target membranes by membrane fusion. They are regulated by trafficking, phosphorylation, ubiquitination, reversible interactions with other signaling proteins and second messengers, proteolytic cleavage, and other modifications. Like other signaling proteins, ion channels are flexible molecules that undergo conformational changes between open (active) and closed (inactive) states. They evolve and increase in number through phylogeny and can be placed in gene families and super families according to their sequence similarities.
Glucose transporters are a wide group of membrane proteins that facilitate the transport of glucose across the plasma membrane, a process known as facilitated diffusion. Because glucose is a vital source of energy for all life, these transporters are present in all phyla.
"A biological database is a large, organized body of persistent data, usually associated with computerized software designed to update, query, and retrieve components of the data stored within the system. A simple database might be a single file containing many records, each of which includes the same set of information."
The attractive force which holds various constituents (atom, ions, etc.) together and stabilizes them by the overall loss of energy is known as chemical bonding. Therefore, it can be understood that chemical compounds are reliant on the strength of the chemical bonds between its constituents; The stronger the bonding between the constituents, the more stable the resulting compound would be.
The attractive force which holds various constituents (atom, ions, etc.) together and stabilizes them by the overall loss of energy is known as chemical bonding. Therefore, it can be understood that chemical compounds are reliant on the strength of the chemical bonds between its constituents; The stronger the bonding between the constituents, the more stable the resulting compound would be.
organic compound, any of a large class of chemical compounds in which one or more atoms of carbon are covalently linked to atoms of other elements, most commonly hydrogen, oxygen, or nitrogen. The few carbon-containing compounds not classified as organic include carbides, carbonates, and cyanides. See chemical compound.
The health effects of hazardous chemicals are often less clear than the physical hazards. Data on the health effects of chemical exposure, especially from chronic exposure, are often incomplete. When discussing the health effects of chemicals, two terms are often used interchangeably - toxicity and hazard.
Biogas is produced after organic materials (plant and animal products) are broken down by bacteria in an oxygen-free environment, a process called anaerobic digestion. Biogas systems use anaerobic digestion to recycle these organic materials, turning them into biogas, which contains both energy (gas), and valuable soil products (liquids and solids).
mass spectrometry, also called mass spectroscopy, analytic technique by which chemical substances are identified by the sorting of gaseous ions in electric and magnetic fields according to their mass-to-charge ratios.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Recovery and purification of intracellular and extra cellular productsBangaluru
Product recovery and purification, such as centrifugal, chromatography, crystallization, dialysis, drying, electrophoresis, filtration, precipitation, etc., are essential finishing steps to any commercial fermentation process.
Iron is a mineral that the body needs for growth and development. Your body uses iron to make hemoglobin, a protein in red blood cells that carries oxygen from the lungs to all parts of the body, and myoglobin, a protein that provides oxygen to muscles. Your body also needs iron to make some hormones.
Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).
new guidance on good data management was discussed and its development
recommended. The participants included national inspectors and specialists
in the various agenda topics, as well as staff of the Prequalification Team
(PQT)–Inspections
Zymography is an electrophoretic technique for the detection of hydrolytic enzymes, based on the substrate repertoire of the enzyme. ... Zymography also refers to a collection of related, fermented products, considered as a body of work.
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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.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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.
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
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
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
1. Vendor Qualification
Identification of Vendor
Material code generation
RAW Material Packing Material
Consumable
Classification
Non Critical
Critical
Vendor questionaries
Review of filled vendor
questionaries
Procurement of 3 lot
sample
QC testing and release
based on approved
specification
Verification of results by
QA
Compliance
Inclusion in provisional
vendor list
Vendor Audit
Technical agreement
Approved vendor list
Vendor questionaries
Review of filled vendor
questionaries
Procurement of 3 lot sample
QC release based on vendor
CoA
Verification of results by
QA
Compliance
Inclusion in provisional
vendor list
Vendor Audit
Technical agreement
Approved vendor list
Classification
Critical Non Critical
Vendor questionaries Vendor questionaries
Review of filled vendor
questionaries
Review of filled vendor
questionaries
Procurement of 3 lot
sample
QC release based on vendor
CoA
QC testing and release
based on approved
specification
Verification of results by
QA
Verification of results by
QA
Compliance
Compliance
Inclusion in provisional
vendor list
Inclusion in provisional
vendor list
Vendor Audit
Technical agreement
Approved vendor list
Vendor Audit
Technical agreement
Approved vendor list
Classification
Critical Non Critical
Vendor questionaries Vendor questionaries
Review of filled vendor
questionaries
Review of filled vendor
questionaries
Material of construction and
technical package shall be
evaluatedd
Based on vendor certification
and availablity of
document,vendor shall be
Based on vendor certification
and availablity of
document,vendor shall be
Compliance
Compliance
Inclusion in provisional
vendor list
Inclusion in provisional
vendor list
Vendor Audit
Technical agreement
Approved vendor list
Vendor Audit
Technical agreement
Approved vendor list
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