ICH CTD QUALITY Part -CMC Module 3 Drug Substance Video by Rajashri Ojha at Raaj PharmaeLearning
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- čas přidán 5. 09. 2024
- THE MODULAR FORMAT OF THE CTD -AN OPPORTUNITY
All departments of a pharmaceutical company can contribute to the efficient compilation of the dossier.
The guidelines provide clear advice on the content of each module.
Individual modules can be prepared as original documents by the appropriate R&D department. The Regulatory Affairs Department of the company needs to provide clear guidance on the requirements on content and format for each module. Company templates can be prepared for each module.
ABOUT US:
RAAJ GPRAC PVT. LTD, India incorporated in the year 2010 which is directly benefiting the society with well-planned welfare projects in Life Sciences; Pharma industries. The Management of RAAJ GPRAC, duly incorporated / registered under the relevant Act and based in Thane district.
RAAJ GPRAC was founded by Rajashri Survase Ojha in 2010 and have been successfully completed 10 years as a Global RA CONSULTANT, TRAINERS & AUDITORS. We offer services into Pharma, Biotech/Biosimilars, Medical Devices, Neutraceuticals, OTC, Foods, and Veterinary after having 27+ years of industrial experience from Sandoz, Ciba-Geigy, Local FDA, Glenmark, GSK-TCS, Novartis, Famycare, Pregna International, Cognizant, Spectrum Pharmatech, Synergy Pharma UAE etc, We do provide GMP, GLP, GCP , GDP & Regulatory services and Pharma TRAININGs across the world through CLASSROOM [CL] Training & DISTANCE learning [DL] education.
Mission of RAAJ GPRAC is to empower the employees productivity and skills development through relevant education/Skill development and market-focused livelihood programs. Education and knowledge is very important for a better life. So knowledge is the power and there is no bigger power than the knowledge of power itself. We conduct various Technical Sessions, Awareness Session and also Power pack sessions for employee productivity.
We are specialized into customized certified Skill Development Programs as per the need of the organization so that manpower will be readily available with the set skills.
Our courses are recognized by Government and NSDC accredited through LSSSDC[Life Science Sectors Skill Development Council]. Our institute is ISO 29990-2010 certified which provides all Advanced knowledge to Fresher’s skilling and Up-skilling for working professionals from Pharma, Biotech, industries and CRO, BPO, KPO etc to BOOST their career. All trained candidates get jobs very easily and prosper into their career very fast. We offer courses as CLASSROOM LEARNING (CL) on Sat/Sunday or through DISTANCE LEARNING (DL) programs. We have trained more than 9500 candidates till date on various subjects across the GLOBE.
The organization profile of RAAJ GPRAC PVT LTD is attached herewith for your ready reference and we can offer a wide range of diversified services as per customer specific requirements:
RAAJ GPRAC regulatory consulting and intelligence team is comprised of senior Regulatory & GMP experts with extensive experience(More than 25yrs) in product development, preparation of global registration strategies and successful registration of drug substance & drug products with different regulatory authorities worldwide. Our team helps in development of drug products as per global regulatory strategies that enable the most efficient registration pathway(s) and yield a high probability of approval success as per country-specific requirements.
We mainly provide services under broad categories;
Ø The portfolio has been developed specifically to help customers expedite the regulatory submission & APPROVAL process and speed time to reach out
GLOBAL market in DRUGS, DRUG PRODUCTS, MEDICAL DEVICES, BIOTECH/BIOSIMILARS, VETERINARY, FOODS & NEUTRACEUTICALS ETC..
Ø GxP compliance services which includes [GMP, GLP, GCP, GDP, Validations, CSV, Data integrity etc.
Ø Audits & PAI as per country-specific requirements. REMEDIATION & SOLUTIONS after 483's & Warning letters.
Ø Regulatory Compilation and Global Submissions (pCTD, eCTD, ACTD, NEES formats) and Technical , CMC, GMP Validation documentation support as per USFDA, EMA, TGA, MCC, UK-MHRA, SFDA, GCC, CFDA , RoW, Russia & CIS, Indian DCGI & CDSCO and other country-specific requirements.
Ø Structured Product Labeling (SPL) for US. Regulatory Operations; Support in submission management planning and publishing strategy, Assist in Document Level (DLP) and Submission Level Publishing (SLP)
Ø MAA CTD for Europe Submission, South Africa-CTD, Australia-CTD, Kenya & Uganda CTD
Ø ACTD ie. ASEAN CTD (Malaysia, Thailand, Philippines, Singapore, Myanmar, Cambodia, Vietnam, Indonesia, Brunei, Laos)
Ø Labeling Management - Preparation of draft Labels for Primary and Secondary Packaging Materials, Patient Information Leaflet &SPC. Side by Side comparison of Labels in reference to innovator
Ø Dossier writing from Module 1 to Module 5 for generic and new drug application [IND, NDA, ANDA, BLA, DMF, ASMF, CEP etc
CTD. eCTD, Nees, ACTD, MRF and RoW formats.
Hi. I am pharmacist from Pakistan, ma'am superb and fruitful lecture. some of points were confusing now it clear after listening your lecture. kind regards,
Thanks
Explained in very simplest way such as complicated module
czcams.com/video/uEtaCc11KP8/video.html
Simply wonder.
Fantastic lecture. Thank you madam for your wonderful service.
It's my pleasure
@@rajashriojha9139 Madam, Do you have books of all your lecture classes? Have you written any books for Pharmaceutical students ?
Thanks a lot for your kind words. Rajashri
Within short presentation everything is relevant. Thank you.
Glad it was helpful!
Thanks a lot for your kind words. Rajashri
Excellently explained. Waiting for more such videos. Requesting you to explain everything by giving some examples as you have given an example of 'Roti', which made it easier to understand.
Thanks a lot for your kind words. Definitely will add few more videos. Rajashri
czcams.com/video/uEtaCc11KP8/video.html
Thanks for d awesome video......pl mk more schools videos
This is really helpful mam thank u so much.
Most welcome 😊
Mam... Thank u very much for your explanation with Very simple english
Useful video. But 8.45 the slide has typo;
Wrong heading, it is not M2; it is 32S. And subsection numericals are also wrong.
Good effort
Mam have you a video on module 2 so please inform me as soon as possible
Thank you for this detailed teaching.
Very clear, excellent explanation
Thanks dear
Asmf is active substance master file.
Who will be submitting the post marketing changes related to ds manufacturing afetr approval of drug? Is it dmf holder or the generic drug company?
Maam y didnt you talk about kitchen? I mean facilities section as a part of module 3?
Sorry I missed your query. DMF holder should maintain Life cycle magmt and Anual updates to keep his DMF ACTIVE status
Mam can you plz guide regarding ,while generating module 3..How to proceed?.. once ..we are aware about all the data available?
Please join our course and you will learn in details about each aspects. You can write to us at rajashrio@gmail.com
Yes, we should get all documents for CMC[Chemistry, Mfg and Control] about Drug substance and Drug products so that you can start your compilation of modules in CTD or eCTD formats
Nice presentation mam.. can you pls explain about how to review the BMR and bpr record for ANDA submission
Hi, please call me next week on 9819125208 and I will explain
@@rajashriojha9139 sure mam
Thanks a lot for your kind words. Rajashri
Ma'am, please recommend a book in which everything is mentioned in detailed about Regulatory.
We have our own book written on CTD eCTD course and Global Regulatory affairs. You will get a copy only after admission to our course. You may please contact us at 9819125208 or write an email at rajashrio@gmail.com
czcams.com/video/uEtaCc11KP8/video.html
What is mean by validation of ctd format?
Profound thanks for your impeccable lectures. Always indebted to you. Could please upload video on module 5 ?
What are the Modules of DMF? For this Question what we have to write please tell me the modules
For dmf module 1, 2 &3 are important. You have to module3 CMC for Drug Substance. CMC is Chemistry, Manufacturing and Control
@@RaajGpracRaajpharmaeLearning means we can write CTD modules in that??
Hi madam I have experience in QA& QC department but I have interest in RA department,is it possible to get job in RA department, please explain me how to get the job and what concept I want learn and interview questions explain me
Hi, you can complete certification courses and can enter into RA field. Give me your email id and whatsapp number to share details about course curriculum. My contact is 9819125208
Hi, yes its possible to make career in RA. Please give me your email id and whatsapp number to send details. Or else you may chat with me on whatsapp at 9819125208
Disliking bcoz of example of roti
That is example for the fresher who want learn cmc