Revised EU Annex 1- Manufacture of Sterile Products (25 Aug 2022) | Comprehensive Training Module

EU has recently published the revised version of Eudralex Volume 4 Annex-1 'Manufacture of Sterile Drug Products' on 25th Aug 2022 with deadline for implementation as 25th Aug 2023.
This comprehensive training module aims to present all the aspects of this important guideline with emphasis on changes as per previous effective version.
The revised guideline is elaborated in detail with changes and updates to requirements for sterile drug manufacturing,
It defines Principles, Pharmaceutical Quality System, Equipment, Premises, Utilities, Personnel, Production Specific Technologies, Environmental & Process Monitoring, Quality Control.
The guideline has details related to Contamination control strategy (CCS), Cleanroom design and qualification, airlocks, airflow & differential pressures, isolators, RABS, Total particle & viable particle monitoring as part of Environmental monitoring program.
It includes details for utilities like water system, steam, gases, heating and cooling system. Details of Personnel training, hygiene, qualification, grade wise gowning, personnel movement has been explained in detail.
Sterilization processes like terminal sterilization, aseptic processing, dry heat sterilization, moist heat sterilization, ethylene oxide sterilization, filter sterilization has been explained. Use of biological indicators (BIs) and validation of sterilization is defined.
Details of pre-use post sterilization integrity test (PUPSIT) has been defined.
Requirements for technologies like Blow Fill Seal (BFS), Form Fill Seal (FFS), Lyophilization (Freeze Drying), closed systems, single use systems (SUS) has been defined in detail.
Media Fill , also known as Aseptic Process Simulation (APS) has been defined in details with all requirements..
Quality control requirements for bioburden assay, sterility testing and reporting of Environmental monitoring data has been explained.

[@ramyav5054]

Useful for many of us. Thanks and hope to see many more.🙏

[@proftalks1680]

Thanks

[@sridharreddykaasam4108]

Thanks Shahanwaz, its good information happy to hear from you

[@proftalks1680]

Thanks for the appreciation

[@vasu3672]

Excellent and presenting in our organization as training module

[@proftalks1680]

Thank you very much 🙏

[@phumiedano]

Thank you very much

[@proftalks1680]

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[@neeldave007]

Superb video...

[@kristamcharan]

Very informative . . . Keep up good work 👍

[@proftalks1680]

Thank you so much for constant support..

[@choudharykudapa]

Very good work shehanaz. keep it up

[@proftalks1680]

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[@kasiviswanath5571]

Very useful info

[@proftalks1680]

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[@syedsartajpeeran2251]

Very useful, could you share this presentation

[@narendrarahangdale5702]

Very good information

[@proftalks1680]

Thank you..

[@vasu3672]

Excellent

[@proftalks1680]

Thank you🙏

[@user-gn9hd1kk8s]

as per current requirement very useful

[@proftalks1680]

Thank you🙏

[@mohdzohair8702]

Nice explanation

[@proftalks1680]

Thanks

[@nikhilakarte]

Nice keep it up

[@proftalks1680]

Thank you very much Nikhil

[@neeldave007]

Please prepare CCS guideline video

[@traveltelugu]

Nice

[@proftalks1680]

Thank you🙏

[@amgadabouzaid6250]

HOW CAN WE GET THIS PRESENTATION THANKYOU IN ADVANCE!!

[@proftalks1680]

Kindly share your email id..

[@amgadabouzaid6250]

@@proftalks1680 i've sent you an e-mail

[@andychen4169]

very useful and could you share this presentation with me

[@proftalks1680]

Thanks

[@proftalks1680]

Please share your email address

[@andychen4169]

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[@amirkamal9121]

i sent you an email can youplease share the presentation with me ?

[@proftalks1680]

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[@jonnyatthedisco]

Nice, but unfortunately the overdriving microphone when you start to speak ist a bit annoying

[@proftalks1680]

Thanks for suggestion will surely address the issue from next presentations

[@ashish1981may]

Nice presentation....can you share the presentation on my email.

[@proftalks1680]

Thanks..