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Biocon Malaysia 483 Observations July 2023 | Learning from USFDA 483s
Biocon Malaysia 483 Observations July 2023 | Learning from USFDA 483s
USFDA Issued 8 483 observations to Biocon Malaysia facility for the inspection conducted in July 2023. The observations are specifically related to investigations of discrepancies like OOS, deviation. It also includes details about discrepancies in sterile practices.
Your queries:
Biocon Malaysia 483 observations 2023
Biocon 483 Observations
USFDA 483 observations
USFDA observation
USFDA non-compliance
USFDA Inspection
#usfda #USFDA Inspection #USFDAobservations #USFDA483
About the Channel:
The channel provides details of pharmaceutical guidelines, important updates on pharmaceuticals and other professional topics like interview preparation, personality development etc.
Contact us at:
shanu4777@gmail.com
ProfTalks1680
www.linkedin.com/groups/13995930/
Subscribe to our channel for more informative videos: ua-cam.com/channels/is3Rsw8ev1d68OC1prwiNQ.html
Переглядів: 932

Відео

Nitrosamine Impurities-Aug 2023 NDSRIs Limit USFDA Guidance | Control of Nitrosamine Guidance Feb-21
Переглядів 14 тис.11 місяців тому
Nitrosamine Impurities - Comprehensive Presentation | USFDA Guidance for Control (Feb-2021) | Limit for NDSRI (Aug-2023) The presentation describes the details of Nitrosamines, their control limits and the determination of AI limit for NDSRIs. #Nitrosamine impurities #Nitrosamine impurities FDA Guidance #Nitrosamine impurities NDSRI Guidance Aug 2023 #USFDA Guidelines #pharmaceutical Your Queri...
Medgel Pharma Indore Warning Letter 20 July 2023 | Learning from USFDA Warning Letters
Переглядів 79411 місяців тому
USFDA Issued Warning letter to Medgel Private Ltd, Indore India (Pithampur) for violations of GMP on 20th July 2023 Your Queries: USFDA Warning Letters 2023 Warning Letters Medgel Warning Letter About the Channel: The channel provides details of pharmaceutical guidelines, important updates on pharmaceuticals and other professional topics like interview preparation, personality development etc. ...
Baxter Pharma Warning Letter 25 July 2023 Ahmedabad | Learning from USFDA Warning Letters
Переглядів 1,6 тис.11 місяців тому
USFDA Issued warning letter to Baxter Ahmedabad facility siting inappropriate investigations and failure to address the visual inspections, repeated and recurrent issues. Your queries: USFDA Warning Letters 2023 Warning Letters Baxter Warning Letter About the Channel: The channel provides details of pharmaceutical guidelines, important updates on pharmaceuticals and other professional topics li...
Intas Pharma Warning Letter 28 July 2023 | Learning from USFDA Warning Letters | 2023 Warning Letter
Переглядів 2,7 тис.11 місяців тому
USFDA issued warning letter to Intas Pharmaceuticals Sanand Facility in Gujrat with 5 observation details for inspection conducted in Nov-Dec 2022. Several Data integrity concerns were noted and other concerns related to OOS investigation, control on computerized systems and process validation were also identified. Your queries: USFDA Warning Letters Warning Letter 2023 Warning Letters About th...
QR Code for Top 300 Medicines in India | Government of India Directive to Curb counterfeit drugs
Переглядів 37111 місяців тому
Government of India has directed all drug manufacturers of the listed 300 medicines to incorporate QR code on the primary or secondary packing labels. This includes tablets like Dolo 650, Glycomet etc. This move is directed to reduce the use of counterfeit and falsified medicines. The Government of India Gazette Notification can be found at: cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB...
Ipca Laboratories Indore USFDA 483 June 2023 | learning from 483's
Переглядів 1,1 тис.11 місяців тому
USFDA conducted inspection for Ipca Laboratories Indore Facility in June 2023 and published an 483 observation report with 8 observations. Your queries: Ipca Indore 483 observations 2023 USFDA 483 observations USFDA observation USFDA non-compliance USFDA Inspection #usfda #USFDA Inspection #USFDAobservations #USFDA483 About the Channel: The channel provides details of pharmaceutical guidelines,...
USFDA Inspections: Overview | Difference between USFDA Inspection & Other Authority Inspections
Переглядів 858Рік тому
This presentation details about the USFDA Inspection process and the compliance aspects to it. It explains about inspection outcomes like USFDA 483 observations, No action indicated, Official action indicated, Voluntary action indicated, Warning letters and import alert. Your queries: USFDA Inspection USFDA Inspection Process USFDA 483 observations USFDA Warning Letter USFDA Import Alert USFDA ...
Centaur Pharma Warning Letter June 2023 USFDA | Learning from Warning Letter
Переглядів 1,6 тис.Рік тому
Centaur Pharmaceuticals Ambernath received a Warning Letter from USFDA in June 2023 for the inspection conducted in Nov-2022. The observations cited include control on document issuance and control by Quality Unit and equipment cleaning. Your Queries: USFDA Warning Letters 2023 Warning Letters USFDA Observation Centaur Warning Letter #usfda #USFDA483 #USFDAInspectionObservations #pharmaceutical...
Intas Ahmedabad 483 Observation May 2023 | Learning from 483s
Переглядів 1,1 тис.Рік тому
Intas Ahmedabad india formulation facility was inspected by USFDA in May 2023 and this resulted in 16 483 observations. The observations are mainly related to below aspects - Aseptic processing - Media Fill interventions - APQR - Investigations - Data Integrity Your queries: USFDA 483 observations Intas 483 Observations Indian Pharmaceutical Company 483 observations #usfda #USFDAInspection #USF...
IPCA Laboratories Ratlam 483 Observation June 2023 | Learning from Observations | API Facility
Переглядів 847Рік тому
Ipca Laboratories Ratlam facility in Madhya Pradesh India was inspected by USFDA in June 2023 which resulted in 11 483 Observations. The observations are related to inadequate investigations for deviations, complaints and OOS, product recall, peak integration in chromatography. Your queries: Ipca 483 observations USFDA 483 Observations USFDA Inspection #usfda #USFDAInspection #USFDA483 #pharmac...
Revised ICH Q9 (R1) Quality Risk Management Guideline | Jan 2023
Переглядів 3,8 тис.Рік тому
ICH Published revised Q9 Guidance as Ver (R1) on 18-Jan-2023. This presentation is aimed at understanding this revised version specifically with reference to the changes. A detailed full explanation of concepts of Quality Risk management with practical example can be visited at: This revised version specifically has 4 major changes as below: 1. Formality in QRM approach 2. Risk based decision m...
Quality Metrics Data Submission USFDA Guidance| USFDA Guidelines |
Переглядів 1,1 тис.Рік тому
The draft guidance for Submission of Quality Metrics data was published in 2016. The Guideline gives details about estimation of quality metrics data, what metrics to report and the frequency. The organizations submitting the data are covered organizations and products are the covered products. The metrics data include: 1. Lot acceptance rate (LAR) 2. Invalidated OOS rate (IOOSR) 3. Product com...
ICH Q12 Product Lifecycle Management
Переглядів 2,5 тис.Рік тому
ICH Q12 Guideline defines the requirement for Pharmaceutical Product Lifecycle Management specifically related to Post approval CMC changes, risk based categorization for submission of CMC changes, established conditions (ECs), Critical Process Parameters (CPPs), Post Approval Change Management Protocol (PACMP), Product Lifecyle Management Document (PLCM) and Post approval commitments. Give det...
ICH Q3C Guidance for Residual Solvents | Class of Residual Solvents | PDE Values of Residual Solvent
Переглядів 3,6 тис.Рік тому
The presentation details the ICH requirements for Residual solvents, the class of residual solvents, calculations of PDE values for residual solvents, steps taken to limit the solvents. Your queries: ICH Guidelines ICH Quality Guidelines Residual Solvents PDE Value for Residual Solvents Classes of Residual Solvents #ich #ichguidelines #ICHQ3C #pharmaceutical About the Channel: The channel provi...
21 CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System requirements
Переглядів 14 тис.Рік тому
21 CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System requirements
Revised EU Annex 1- Manufacture of Sterile Products (25 Aug 2022) | Comprehensive Training Module
Переглядів 13 тис.Рік тому
Revised EU Annex 1- Manufacture of Sterile Products (25 Aug 2022) | Comprehensive Training Module
ICH Q3D Guidance for Elemental Impurities | Example for calculating | Permitted Daily Dose (PDE)
Переглядів 10 тис.Рік тому
ICH Q3D Guidance for Elemental Impurities | Example for calculating | Permitted Daily Dose (PDE)
Revised Out of Specification (OOS) Guidance | USFDA Guidance | OOS Guidance May 2022
Переглядів 10 тис.Рік тому
Revised Out of Specification (OOS) Guidance | USFDA Guidance | OOS Guidance May 2022
ICH Q9 Guidance for Quality Risk Management | With simplified example
Переглядів 14 тис.2 роки тому
ICH Q9 Guidance for Quality Risk Management | With simplified example
USFDA Guidance for Data Integrity | USFDA Guidelines for Pharmaceutical | Easy Explanation
Переглядів 5 тис.2 роки тому
USFDA Guidance for Data Integrity | USFDA Guidelines for Pharmaceutical | Easy Explanation
ICH Q10 Guidance for Pharmaceutical Quality System | Guideline for Pharmaceutical Industry
Переглядів 12 тис.2 роки тому
ICH Q10 Guidance for Pharmaceutical Quality System | Guideline for Pharmaceutical Industry
USFDA Guidance for Pharmaceutical Quality System | USFDA Guidelines for Pharmaceuticals |
Переглядів 2,8 тис.2 роки тому
USFDA Guidance for Pharmaceutical Quality System | USFDA Guidelines for Pharmaceuticals |
How to answer the interview question on 'What are your strengths?' | Interview question
Переглядів 2663 роки тому
How to answer the interview question on 'What are your strengths?' | Interview question
Don'ts of Interview | Things not to talk about in the interview
Переглядів 2873 роки тому
Don'ts of Interview | Things not to talk about in the interview
How to prepare for interview | Tips for Interview Preparation | 5 Steps for Interview Preparation
Переглядів 6363 роки тому
How to prepare for interview | Tips for Interview Preparation | 5 Steps for Interview Preparation
How to introduce youself in interview | Tell me about yourself | Describe Yourself | Interview Prep
Переглядів 9323 роки тому
How to introduce youself in interview | Tell me about yourself | Describe Yourself | Interview Prep

КОМЕНТАРІ

  • @willsshepherd2976
    @willsshepherd2976 Місяць тому

    ua-cam.com/video/PTVcIp8p-jQ/v-deo.htmlsi=0YdwvBfq6F7kvJx7 nitrosamine as party drugs.

  • @shaikhmerajuddin5045
    @shaikhmerajuddin5045 Місяць тому

    Plz make more videos on FDA observation these are very knowlegeable

  • @user-sc7sv8nm6s
    @user-sc7sv8nm6s Місяць тому

    what is b(4)

  • @manojmodi414
    @manojmodi414 Місяць тому

    Thank you very much Sir,

  • @thetenderloins6564
    @thetenderloins6564 Місяць тому

    Thanks a ton for clearly explaining! Really helpful and crisp!

  • @vinitpatil862
    @vinitpatil862 2 місяці тому

    Thank you... nicely compiled.

  • @harishasnayak5249
    @harishasnayak5249 2 місяці тому

    Hi can u conduct more training on nitrosamine

  • @purnachandraraokolli2581
    @purnachandraraokolli2581 2 місяці тому

    good explanation with real time exposure.....

  • @drvica7633
    @drvica7633 3 місяці тому

    Thank You so much, greeting from México, it was a very useful example for a Work Medicine class, Im a First Year resident of this speciality, and that example works a lot, than you!

  • @SateeshKumarSingh-we9jv
    @SateeshKumarSingh-we9jv 3 місяці тому

    Great easy way to understand ich q9

  • @syedsartajpeeran2251
    @syedsartajpeeran2251 3 місяці тому

    Very useful, could you share this presentation

  • @bkalyan7555
    @bkalyan7555 3 місяці тому

    Good contemt..

  • @PramodKumar-mu9bn
    @PramodKumar-mu9bn 3 місяці тому

    Nice presentation but you are saying grams as mg

  • @mohitjhansi
    @mohitjhansi 4 місяці тому

    Lage raho bhai outstanding effort

  • @charan2804
    @charan2804 4 місяці тому

    But as of today also why it us not implemented in the medicines as we cant see any qr in the medicine will it be implemented

  • @yadhavaable
    @yadhavaable 5 місяців тому

    Sir plase share the pdf of this presentation.

  • @krishnanallagorla
    @krishnanallagorla 5 місяців тому

    Exalent gathering

  • @swapnilwalekar2926
    @swapnilwalekar2926 6 місяців тому

    Well explained ,i want ppt form for this

  • @satya10drl
    @satya10drl 6 місяців тому

    Excellent

  • @prady654
    @prady654 7 місяців тому

    i love the way it is presented, and would be happy to see many topics in your channel, best wishes.

  • @prady654
    @prady654 7 місяців тому

    i should really appreciate the way it was explained, big thanks.

  • @vijaysm7557
    @vijaysm7557 7 місяців тому

    Please provide an example, how the revised guidelines used in API industries

  • @vijaysm7557
    @vijaysm7557 7 місяців тому

    It's very nice addressed

  • @sejalkale3957
    @sejalkale3957 7 місяців тому

    Reference of this information

  • @Ishika_712
    @Ishika_712 7 місяців тому

    Please share pdf file of this presentation

  • @Ishika_712
    @Ishika_712 7 місяців тому

    Hi

  • @neeldave007
    @neeldave007 7 місяців тому

    Please prepare CCS guideline video

  • @neeldave007
    @neeldave007 7 місяців тому

    Superb video...

  • @abhishekjoshi9650
    @abhishekjoshi9650 7 місяців тому

    Thank you

  • @yongmoonlee750
    @yongmoonlee750 8 місяців тому

    thanks for reviewing USP guideline

  • @user-iq5hz1tj6c
    @user-iq5hz1tj6c 8 місяців тому

    Hi Sir, Nice information. Can you able to provide the presentation if possible.

  • @054phatangareshraddha6
    @054phatangareshraddha6 8 місяців тому

    Very much helpful..plz upload such videos and cover whole ich guidelines..it seems easy by virtual explanation rather then reading..

  • @sspodcasts2236
    @sspodcasts2236 8 місяців тому

    Thank you so much sir 🎉.. I was going through guidelines pdf i couldn't understand but this helped

  • @VijayKumar-hu7ou
    @VijayKumar-hu7ou 8 місяців тому

    Sir ,diring traing you mention we can take pharmaceutical issue as an example plese make one more video ,so that we can understand in depth.thank you sir

  • @VijayKumar-hu7ou
    @VijayKumar-hu7ou 8 місяців тому

    Good information sir

  • @rajtigris
    @rajtigris 9 місяців тому

    Very well presented! Thanks ProfTalks

  • @ashleyparker9143
    @ashleyparker9143 9 місяців тому

    This is great, please do another video including the practical implementation of the guidance with a examples/case studies

  • @narendragirase36
    @narendragirase36 9 місяців тому

    Nice presentation sir plz also provide presentation on EU inspection

  • @ahmedginidi2020
    @ahmedginidi2020 9 місяців тому

    More than perfect, sir

  • @pottasiri
    @pottasiri 9 місяців тому

    Hi Never seen such video in youtube about 483 interpretation. Really appreciate your patience for interpretation of long 483 form. Could you please let us know what is escalation 161 given in this 483 by 3rd party consultant

  • @pottasiri
    @pottasiri 9 місяців тому

    Hi Though this was posted 3 yrs ago, I could able to reach this video. It's amazing content even after 3 yrs.

  • @bhavanigandi3859
    @bhavanigandi3859 10 місяців тому

    Please do vedio in QRM tools

  • @rakeshscetic
    @rakeshscetic 10 місяців тому

    very useful information. May I have your contract details..

  • @bhavanigandi3859
    @bhavanigandi3859 10 місяців тому

    Thank you sir for providing valuable information. Request to make more presentations on ICH guidelines, Relavent USP chapters and CFR guidelines.

  • @ramakrishnaguttula7941
    @ramakrishnaguttula7941 10 місяців тому

    Thanks for sharing sir

  • @ramakrishnaguttula7941
    @ramakrishnaguttula7941 10 місяців тому

    Excellent video sir

  • @manojmodi414
    @manojmodi414 10 місяців тому

    Thank you very much Sir

  • @narendrarahangdale5702
    @narendrarahangdale5702 10 місяців тому

    Very good information

  • @sowndaryam2491
    @sowndaryam2491 10 місяців тому

    The best presentation for QRM... Pls explain QRM tools sir... Thank you

  • @Hollywoodbollywood2265
    @Hollywoodbollywood2265 10 місяців тому

    Very very nice informatic 👍👏👏