In the pharmaceutical industry, “Technology Transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full-scale commercialization.
This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Technology transfer from Research and development to productionArchana Mandava
Technology transfer process from R&D to production, Granularity,Complete process from raw materials to finished products, analytical method transfer,Transfer protocol, responsibilities
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Introduction to Change Control.
Definition of Change Control.
Function of Change Control.
Area of Change.
Written Procedures and Documentation.
This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Technology transfer from Research and development to productionArchana Mandava
Technology transfer process from R&D to production, Granularity,Complete process from raw materials to finished products, analytical method transfer,Transfer protocol, responsibilities
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Introduction to Change Control.
Definition of Change Control.
Function of Change Control.
Area of Change.
Written Procedures and Documentation.
Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of technical and business knowledge along with the development of steps to define the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems.
technology transfer of liquid oral and supac guidelines ASHISH SUTAR
logical procedure that controls the transfer of any process together with its documentation and professional expertise between developments or between manufacture sites.
Pharmaceutical Technology Transfer Best PracticesAnthony Grenier
Key Takeaways from the Technology Transfer Guidelines
• Standardize checklist for transferring product development, process development, and analytical method development knowledge
• Requirements are summarized in key deliverables and reports
WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging, and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT-related documentation - confidentiality agreement, licensing, MoUs, legal issues
A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred
Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.
Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.
Overview of Technology Transfer in Pharmaceutical Industryijtsrd
This essay discusses technology transfer, its uses, and how important they are to the finding of new drugs and the creation of new pharmaceuticals. Additionally, it is necessary to improve the drug quality intended during research and development, to the finished product during production, and to ensure that consistent quality is needed. This research aimed to examine the significance of technology transfer, its components, and manufacturing unit technology transfer policies. The shift contributes to the technical advancement of succeeding companies through RandD and startup companies. A. Ezhilarasi | Dr. K. Devi | Shantaram Nangude "Overview of Technology Transfer in Pharmaceutical Industry" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd54023.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/other/54023/overview-of-technology-transfer-in-pharmaceutical-industry/a-ezhilarasi
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.
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.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
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.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
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
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
Technology Transfer portfolio in Pharmaceutical Industry
1. LOGO Seminar on
“Technology Transfer
portfolio in Pharmaceutical
Industry”
‘‘Technology is best when it brings people together’’
Presentation By:
Mr. Akshay S. Jirage
Formulation Development
2. 24/04/2017
Contents
Documentation Involved in TT
Anatomy component of TT
What is Technology transfer (TT)
Facets involved in TT
Importance of Technology transfer
Policy and factor of TT
1/16
Goals and steps involved in TT
References
In pharma industry Technology Transfer abbreviated as ‘TT’
3. 24/04/2017
What is Technology Transfer
❖In the pharmaceutical industry, “Technology Transfer” refers
to the processes that are needed for successful progress from
drug discovery to product development to clinical trials to full-
scale commercialization.
• Vertical Technology transfer (from R&D to full scale commercialization)
• Horizontal Technology transfer (From one commercial site to another commercial site)
❖ It enable to upgrade drug quality planned during research
development and to final product during manufacturing as well
as to guarantee that stable quality is transferred.
❖ According to WHO, Transfer of technology is defined as “a
logical procedure that controls the transfer of any process
together with its documentation and professional expertise
between development and manufacture or between manufacture
sites”.
2/16
4. 24/04/2017
Diagrammatic presentation
Production/commercial scale
Pilot scale
Scale up batch
Small scale laboratory
development
Batch size 200-1000kg*
Batch size 20-100kg
Batch size 5-10kg
Batch Size 05-2 kg
* Batch size may vary in commercial scale depend on availed capacity of equipment,
3/16
5. 24/04/2017
Cycle Diagram represents ‘TT’
Feasibility
study
Production
R&D
lab
Stability
studies
Validation
batches
Technology
transfer
Scheme of product
commercialization
Scale Up
4/16
6. 24/04/2017
Importance of Technology Transfer
As ‘TT’ has numerous importance in pharma sector for which
elaborate purpose are as follows:
❖ To elucidate necessary information to transfer technology
from R&D to actual manufacturing
❖ It provides an opportunity to reduce cost on drug discovery
and development
❖ For smooth manufacturing of commercialized product.
❖ Maintain quality of product and to achieve standardized
process.
❖ Documented evidence of the manufacturing process for drug
substance and drug products
❖ It provides an opportunity to reduce cost on drug discovery
and development
5/16
7. 24/04/2017
Facets for ‘TT’
❖ Premises involved in TT:
• Government lab to private sector firm
• Between private sector firm of same country
• Between private sector firm of different country
• From academia to private sector firm
• Academia, government and industry collaboration
❖ facets for TT:
• Lack of manufacturing capacity
• Lack of resources to launch product commercially
• Lack of marketing and distribution capability
• Exploitation in a different field of application
6/16
8. 24/04/2017
Policies involved in ‘TT’
❖ Policies:
• Experience in the business sector. It has to
demonstrate a reputable experience
• Cultural compatibility:It should belong to the same
geographic region
• Confidentiality: It should be guaranteed by signing a
secret agreement.
• Relations: with other institutions subcontracted in turn.
Application of the same rules as in the main contract.
• Financial solvency. Accreditation by a company
specialized in this kind of audits.
• The compliance with the regulatory requirements is
assured.
7/16
9. 24/04/2017
Factors involved in ‘TT’
Development
priorities
Factors
Technology Transfer
Viable market
Political stability
Economy
Regulations
Skilled workers
EnforcementIPR
8/16
10. 24/04/2017
Goals involved in ‘TT’
9/16
Goals:
❖To take all the gathered knowledge and use it as the basis for
the manufacturing control strategy, the approach to process
qualification and on-going continuous improvement.
❖
❖The transition of the product/process/analytical method
knowledge between development and manufacturing sites.
❖To ensure variability of process and parameters are controlled
and sufficient in the face of the rigors of a commercial production
environment.
❖To verify parameters established during development are still
within the determined design space and adjusted at scale-up.
11. 24/04/2017
Factors Affecting on ‘TT’
Development
priorities
Factors
Technology Transfer
Viable market
Political stability
Economy
Regulations
Skilled workers
Development
prioritiesIPR
There are list of factors affects technology transfer. From
which potential are as below.
10/16
12. 24/04/2017
Steps involved in ‘TT’
Development
Phase
Production
Phase
Research
Phase
▪Selection of
Excipients
▪Process Design
▪Pre-formulation
▪Improvement of
Efficacy
▪Product stability
It involves transfer
of product from
R&D to product
development
laboratory (PDL)
▪In this phase
Technology
Transfer Dossier
(TTD) handed over
to PDL
It involves
▪Validation
studies
▪Scale up
Parameters
•Flexibility
•Cost
•Dependability
•Innovation and
product quality
11/16
13. 24/04/2017
Anatomy component of ‘TT’
Technology
Transfer
B
E
C
D
A
‘Techno-ware’
▪Equipment
▪Physical objects
‘Human-ware’
▪Skilled personnel
▪Trainers
‘Info-ware’
▪Knowledge
▪Information
technology
Market
mechanism
▪Foreign direct
investment (FDI)
‘Orga-ware’
▪Knowledge of
organizational procedure
12/16
14. 24/04/2017
Documentation involved in ‘TT’
13/16
It involves data from initial development phase to successful
commercialization with critical aspects of manufacturing.
❖Research and development reports:
▪Detailed developmental outcomes from trails
▪Dosage form and formula design
▪Rationale for design of manufacturing methods
▪Rational and change histories of important processes and control
parameters
▪Quality profiles of manufacturing batches (including stability
data)
▪Specifications and test methods of drug substances,
❖Product Specification File (PSF):
▪Quality assurance of the product
▪Assurance of operation safety
Cont..
15. 24/04/2017
Documentation involved in ‘TT’
14/16
▪Environmental impact assessment
▪Information of costs
▪Other specific information of the product
❖Technology Transfer Plan:
▪Procedure of TT
▪Transfer Schedule
▪Establishment and judgment criterion
❖Technology Transfer Report (TTR):
▪Action points
▪Evaluation of technology plan
❖Approval by Quality Assurance Department
▪Confirm the process of technology transfer
Cont..
16. 24/04/2017
Documentation involved in ‘TT’
15/16
❖Technology Transfer Dossier (TTD):
Site designee shall receive TTD from R&D it include following parameters
of dossier:
▪Molecule information
▪Proposes Markets
▪Master Formula Card
▪Master Packaging Card
▪Critical process parameters
▪Shipping requirements
▪Standard test procedures for Raw materials/packing
materials/in-process/Finished product specifications.
▪Finished Product Specifications
▪Special Sampling requirements if any
▪Stability testing requirement
▪Product Development Report.
17. 24/04/2017
Conclusion
Action to transfer
of information and
technologies for
product realization.
Bridge between
‘Donor side’ (R&D
or knowledge
center) and
‘Receptor side’
(drug mfg. site).
Technology
Transfer
‘3P” evaluated
in ‘TT’ are:
Plan
Process
Personnel
16/16
18. 24/04/2017
References
1. Technology transfer in Pharmaceutical Industry: A review by Bharat
Bhusan et al. / Int. J. Pharm. Med. Res. 2014; 2(3): 94-99
2. Pharmaceutical technology transfer: an overview Alam and Ahmad,
IJPSR, 2013; Vol. 4(7): 2441-2449
3. Technology transfer in pharmaceutical industry- A Review Popat B.
Mohite and Sachin V. Sangle / International Journal of Advances in
Pharmaceutics 2017; 06(01): 01-07.
4. Rahul D Et.al. Technology transfer in pharmaceutical industry transfer
of process from development to commercialization. Int J pharm sci
res. 2013;4(5):1695
5. 2. Guidance for industry pharmaceutical quality system ICH Q10. FDA,
CDER, CBER. 2009;:08
6. Manish SM, Bharat P, Yakub S, Technology Transfer in Pharmaceutical
Industry; Facts and Steps Involved, American Journal of Pharmatech
Research, 2012; 2(4):78.
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