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Pharmaceutical resource and education services
Belgium
Registrace 6. 04. 2018
Pharmaceutical Resource and Education Services ( PRES) is committed to provide a quality training and education services. All the content in this channel is free of cost. Its a novel mission carried out by PRES to educate the entire pharmaceutical and health care professional. Knowledge is the key of success and empower you to grow in your career.
Channel Maintain by : Palash Chandra Das , SME in sterile operation & practices (M.Pharm)
Mail id: mail2uscgmp@gmail.com,
LinkedIn : www.linkedin.com/in/palashchandradas/
FAQ:
1. Why we are different from other ?
We directly discuss about actual regulatory requirements through technical article, guidance or regulations. We help to understand better the cGMP requirements.
2. Can we include this video for institutional or organization training ?
Yes, you can utilize this educational video to your students or employees.
Channel Maintain by : Palash Chandra Das , SME in sterile operation & practices (M.Pharm)
Mail id: mail2uscgmp@gmail.com,
LinkedIn : www.linkedin.com/in/palashchandradas/
FAQ:
1. Why we are different from other ?
We directly discuss about actual regulatory requirements through technical article, guidance or regulations. We help to understand better the cGMP requirements.
2. Can we include this video for institutional or organization training ?
Yes, you can utilize this educational video to your students or employees.
Shorts#001 - Pass boxes used in Pharmaceutical Facility
In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. #pharma #pharmaceutical #pharmaceutical #healthcare
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
Follow me,
Read my blog Pharmaceutical resource and educational services at: pres.net.in/blog/
Follow me at LinkedIn : www.linkedin.com/in/palashchandradas/
Follow me at Twitter : palash_das
Follow me at Instagram: pharmacistpalash
Join Me,
Admin and Member of "Global Federation of Pharmaceutical Industrial Association"
Free joining link : groups/onlinepharma
Share your queries and concern at mail2uscgmp@gmail.com
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
Follow me,
Read my blog Pharmaceutical resource and educational services at: pres.net.in/blog/
Follow me at LinkedIn : www.linkedin.com/in/palashchandradas/
Follow me at Twitter : palash_das
Follow me at Instagram: pharmacistpalash
Join Me,
Admin and Member of "Global Federation of Pharmaceutical Industrial Association"
Free joining link : groups/onlinepharma
Share your queries and concern at mail2uscgmp@gmail.com
zhlédnutí: 94
Video
F0 Value of Moist Heat Sterilization
zhlédnutí 690Před 8 měsíci
F0 is the equivalent exposure time at 121.11°C of the actual exposure time at a variable temperature, calculated for an ideal microorganism with a temperature coefficient of destruction equal to 10 °C. This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year ...
Moist Heat Sterilization - Latest EU Annex 1
zhlédnutí 503Před rokem
EU Annex 1 Moist Heat Sterilization requirement are explained here. Presentation available in English and Hindi. Skip the English part if you wanted to listed in Hindi. Skip the Hindi part ant second half if you are English listeners. What is sterilization by moist heat? Sterilization by moist heat is also known as steam sterilization. Moist heat sterilization destroys microorganisms in a produ...
Sterility Assurance - Concept and fundamentals
zhlédnutí 2,1KPřed 2 lety
Sterilization is an essential stage in the processing of any product destined for parenteral administration, or for contact with broken skin, mucosal surfaces, or internal organs, where the threat of infection exists. In addition, the sterilization of microbiological materials, soiled dressings and other contaminated items is necessary to minimize the health hazard associated with these article...
हिंदी में आइसोलेटर सीखें _Isolator Qualification with H2O2 Decontamination
zhlédnutí 4,2KPřed 2 lety
आइसोलेटर के VHP डोन्टामिनाशन बारेमे सीखिये Isolator Qualification with H2O2 Decontamination This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production an...
Clean Utility Vs Raw utility use in Pharmaceutical Manufacturing Facility
zhlédnutí 2,3KPřed 2 lety
Clean Utility Vs Raw utility use in Pharmaceutical Manufacturing Facility This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assuranc...
Sterile Injectable Manufacturing Process ( Part 2)
zhlédnutí 1,8KPřed 2 lety
Sterile Injectable Manufacturing Process ( Part 2) Drug products that are delivered via the parenteral, ophthalmic, inhaled, or otic route present an increased risk of infection or harm because they bypass many of the body’s natural defenses. To ensure patient safety, the FDA requires that drug products delivered via these routes be supplied as sterile products. This designation includes many c...
Regulations (USFDA and EU) and guidance related to Biological indicator (BI) used in Sterilization
zhlédnutí 585Před 2 lety
Regulations (USFDA and EU) and guidance related to Biological indicator (BI) used in Sterilization This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Produc...
Terminally Sterilized Products - Manufacturing Controls
zhlédnutí 561Před 2 lety
Terminally Sterilized Products - Manufacturing Controls: This video demonstrated manufacturing controls for terminally sterilized products. This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In ...
Easy Steps For Making and Editing Video Presentation
zhlédnutí 76Před 2 lety
Easy Steps For Making and Editing Video Presentation This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I h...
Terminal Moist Heat Sterilisation Process
zhlédnutí 1,1KPřed 2 lety
Terminal sterilization is a process whereby a product is sterilized in its final container or packaging, and which permits the measurement and evaluation of quantifiable microbial lethality. This training session discussed regarding Air-Steam and Superheated water sterilization process. This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have complete...
Definition and Comparison of Different Sterility Assurance Related Topics
zhlédnutí 311Před 2 lety
This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field an...
Myth or Facts....Exposure of 3 min at 300°C necessary for Depyrogenation in Tunnel Dry heat PQ ?
zhlédnutí 1,5KPřed 2 lety
This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field an...
483 observation analysis on Moist Heat Terminal Sterilization TS process
zhlédnutí 580Před 2 lety
This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field an...
Investigate a faulty Investigation ! (Part 2 - What Good Investigation looks like)
zhlédnutí 220Před 2 lety
Investigate a faulty Investigation ! (Part 2 - What Good Investigation looks like)
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
zhlédnutí 1,1KPřed 2 lety
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
483 or warning letter due to Inappropriate Investigation ? Lets Investigate a faulty Investigation !
zhlédnutí 719Před 2 lety
483 or warning letter due to Inappropriate Investigation ? Lets Investigate a faulty Investigation !
How to calculate depyrogenation tunnel belt speed
zhlédnutí 4,8KPřed 2 lety
How to calculate depyrogenation tunnel belt speed
How to investigate a microbial failure in Aseptic injectable process ?
zhlédnutí 1,3KPřed 2 lety
How to investigate a microbial failure in Aseptic injectable process ?
Part1-Sterility Assurance assessment considering EU Annex1(draft)
zhlédnutí 378Před 2 lety
Part1-Sterility Assurance assessment considering EU Annex1(draft)
Sterility Assurance assessment with EU Annex 1 Promotional clips
zhlédnutí 166Před 2 lety
Sterility Assurance assessment with EU Annex 1 Promotional clips
Concept of biological lethality and SAL calculation (applying moist heat sterilization process)
zhlédnutí 687Před 2 lety
Concept of biological lethality and SAL calculation (applying moist heat sterilization process)
Concept of thermal lethality applying steam sterilization process (D-Value, Z- Value, Fphy and F0)
zhlédnutí 2,5KPřed 2 lety
Concept of thermal lethality applying steam sterilization process (D-Value, Z- Value, Fphy and F0)
Brief overview On Quality Risk Management
zhlédnutí 511Před 3 lety
Brief overview On Quality Risk Management
Freeze drying/ Lyophilization basics and fundamentals
zhlédnutí 4,1KPřed 3 lety
Freeze drying/ Lyophilization basics and fundamentals
Pharmaceutical learning resources (Part 1) - Get free courses (i.e. USP, FDA) with certification
zhlédnutí 2,2KPřed 3 lety
Pharmaceutical learning resources (Part 1) - Get free courses (i.e. USP, FDA) with certification
Qualification approach of depyrogenation tunnel used in sterile injectable facilities
zhlédnutí 14KPřed 3 lety
Qualification approach of depyrogenation tunnel used in sterile injectable facilities
Overview of Sterile Injectable Manufacturing Process (Liquid and Lyophilized)
zhlédnutí 15KPřed 3 lety
Overview of Sterile Injectable Manufacturing Process (Liquid and Lyophilized)
All the Best.
Please explains change control risk assessment, impact assessment and action items for change in excipient, API vendor Change in equipment Change in area Change in location / site Introducing new product Change in batch size Change in software
Super
Sir, will you please answer my below question. Why ampoule products require sterilization and vial products for depyrogenation. Can we use depyrogenation tunnel for ampoule product
Yes, depyrogenation tunnel can be used for Vial and Ampoule both in case of aseptic manufacturing process.
@@cGMP what is the differences between aseptic & sterile process.
Have you made any vedio on injectable machines from engineering point of view of totally related to technical issues and maintenance.
Sir plz confirm that Dwell time and fd value is same in tunnel validation
Very helpful voor video
Thanks a lot
Can you share xls file download link
Thanks continue
Very department expansion good
Can you clarify this from EU Volume 4 annex 1 as I am confused how to include load dryness by visual inspection in SOP or part of line clearance? 8.56 The items to be sterilised, other than products in sealed containers, should be dry, packaged in a protective barrier system which allows removal of air and penetration of steam and prevents recontamination after sterilisation. All loaded items should be dry upon removal from the steriliser. Load dryness should be confirmed by visual inspection as a part of the sterilisation process acceptance.
very good understanding
Very informative..... well explained.....
Very informative content 👌 👏
Its informative
There is one more possibility of introducing H2O2 by turbulent flow through nozzle directly to the chamber, in IMA machine we had qualified.For your information
Knowledgeable 📸 video sir ji
Sir please explain about nitrosamine risk assessment
Tone is controlled very well. Try to show CC document also
As high pressure will be there in infeed zone of filling machine? Possible for air turbulence?
Is that air from hot zone can go to cool zone? Possibility for Contamination?
Great work done. Thanks for the presentation 👍
Nice presentation
Good
🤷 𝓹𝓻𝓸𝓶𝓸𝓼𝓶
The book "300 Questions About Drug Product Manufacturing" on A. did help me a lot!
Good explanation sir my dout compounding main checking points and critical observation Kya Kya hey mey ipqa mey job karahun
Thank you so much Palas, you videos are very informative
sir please explain about Risk assessment on new facility creation
Thank you
Neat n simple explanation... Thank you
dear palash , very good clarity on subject , good luck for your journey
Gracias, greetings from Perú
Sir please explain in Hindi also ..
Hindi me video banaye
Please Hindi so everyone can learn sir 🙏
Please tell about Fh value limit for depyrogenation at 320
Very helpful in short time video. Thanks sir
Very useful information you are sharing 👌🏻👌🏻👌🏻
Thanks Palash for this presentation Request for detail presentation on media fill simulation
very detailed explanation!
Also in the previous video you mentioned that cleaning of primary packaging materials such as vials is happened in the grade D area whereas now you're saying it's happening in the Grade C area? Can you confirm where it happens?
Grade C area will be appropriate for Vial washing.
I just wanted to know - Filteration of the Drug product which is in the holding vessel is happening in the Grade C area with Laminar air flow Grade A? - Terminal sterilization And filteration and sterilization of Drug product which is in the holding vessel is happening in the Grade B area with Grade A laminar air flow - Asceptic sterilization Is this correct?
Yes, Grade C under laminar air flow is appropriate for product produce in Terminal Sterilisation facility
Dear Mentor,Thank you so much,
Very well.
How to evaluate & fix Ramp time & Soak time either in primary or secondary drying. Pl. Clarify it sir.
Would you please share the relation between D value and F(physical) vlue?
No relation with Fphy and D value. D-value is the resistance of Biological Indicator. To calculate Fphy of Sterilization process time , temperature and z-value is required
What reason behind maintain 300 degrees only.
Check my video czcams.com/video/TGTWu-CRg3E/video.html