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Pharma Quality
India
Registrace 17. 10. 2023
Pharma Quality is a CZcams channel which provides content related to various good practices followed in the pharmaceutical industry based on the practical approach by the industry experts with years of experience.
The channel aims to help organizations, professionals and students to know about the regulatory requirements and current Pharma quality standards.
We help at every step of your growth, career and learning journey.
Join this community to improve the quality and safety of products.
The channel aims to help organizations, professionals and students to know about the regulatory requirements and current Pharma quality standards.
We help at every step of your growth, career and learning journey.
Join this community to improve the quality and safety of products.
Mastering Good Documentation Practices in Pharma: A Complete Guide
Mastering Good Documentation Practices in Pharma: A Complete Guide
zhlédnutí: 194
Video
Field Alert Report (FAR) Explained: FAR Submission Process
zhlédnutí 162Před měsícem
Field Alert Report (FAR) Explained: FAR Submission Process
Mastering Out of Specification (OOS) in the Pharmaceutical Industry: A Step-by-Step Guide
zhlédnutí 743Před měsícem
Mastering Out of Specification (OOS) in the Pharmaceutical Industry: A Step-by-Step Guide
Ensuring Data Integrity: Alcoa++ demonstrated for Pharma Industry
zhlédnutí 498Před 2 měsíci
Ensuring Data Integrity: Alcoa demonstrated for Pharma Industry
Mastering Analytical Instrument Qualification USP 1058!
zhlédnutí 263Před 2 měsíci
Mastering Analytical Instrument Qualification USP 1058!
Cracking the Code: Simplifying EU Annex 11 Computerized System Guidelines
zhlédnutí 719Před 2 měsíci
Cracking the Code: Simplifying EU Annex 11 Computerized System Guidelines
Fishbone Ishikawa Diagram: A Commonly Used Investigation Tool Explained
zhlédnutí 441Před 3 měsíci
Fishbone Ishikawa Diagram: A Commonly Used Investigation Tool Explained
5 Why Analysis: A Commonly Used Investigation Tool Explained
zhlédnutí 310Před 3 měsíci
5 Why Analysis: A Commonly Used Investigation Tool Explained
Insider Insights: Best Practices for Pharma Incident Handling
zhlédnutí 581Před 3 měsíci
Insider Insights: Best Practices for Pharma Incident Handling
A deep dive into Quality Control Laboratory in Pharmaceutical Industry
zhlédnutí 595Před 3 měsíci
A deep dive into Quality Control Laboratory in Pharmaceutical Industry
Cracking the Code: Simplifying 21 CFR Part 11 Guidelines
zhlédnutí 1,8KPřed 4 měsíci
Cracking the Code: Simplifying 21 CFR Part 11 Guidelines
Writing effective SOP: Key Elements You Need to Know I Standard Operating Procedure
zhlédnutí 171Před 4 měsíci
Writing effective SOP: Key Elements You Need to Know I Standard Operating Procedure
Basics of Pharmacopeia: Understanding Monographs and USP-NF.
zhlédnutí 691Před 4 měsíci
Basics of Pharmacopeia: Understanding Monographs and USP-NF.
Demystifying Computerized System Validation: Top 25 Questions Answered
zhlédnutí 1,6KPřed 4 měsíci
Demystifying Computerized System Validation: Top 25 Questions Answered
Mastering Deviations Handling in the Pharmaceutical Industry: A Step-by-Step Guide
zhlédnutí 4,4KPřed 5 měsíci
Mastering Deviations Handling in the Pharmaceutical Industry: A Step-by-Step Guide
Mastering Change Control Process in the Pharmaceutical Industry: A Step-by-Step Guide
zhlédnutí 7KPřed 5 měsíci
Mastering Change Control Process in the Pharmaceutical Industry: A Step-by-Step Guide
Mastering Corrective and Preventive Action (CAPA) in the Pharmaceutical Industry
zhlédnutí 2,3KPřed 5 měsíci
Mastering Corrective and Preventive Action (CAPA) in the Pharmaceutical Industry
Maximizing Compliance: Using Traceability Matrix in Computer System Validation
zhlédnutí 429Před 5 měsíci
Maximizing Compliance: Using Traceability Matrix in Computer System Validation
Validation Summary Report: Your Key to Successful Computerized System Validation
zhlédnutí 395Před 6 měsíci
Validation Summary Report: Your Key to Successful Computerized System Validation
Optimizing Performance: Qualification (PQ) in Computerized Systems
zhlédnutí 392Před 6 měsíci
Optimizing Performance: Qualification (PQ) in Computerized Systems
Mastering Operational Qualification for Computerized Systems | 21 CFR Part 11 & EU Annex 11
zhlédnutí 786Před 6 měsíci
Mastering Operational Qualification for Computerized Systems | 21 CFR Part 11 & EU Annex 11
Ensuring Compliance: Installation Qualification for Computerized Systems in Pharma
zhlédnutí 546Před 6 měsíci
Ensuring Compliance: Installation Qualification for Computerized Systems in Pharma
How to Conduct a Comprehensive Functional Risk Assessment for Computerized Systems
zhlédnutí 1KPřed 7 měsíci
How to Conduct a Comprehensive Functional Risk Assessment for Computerized Systems
The Essential Guide to Design & Configuration Specification
zhlédnutí 572Před 7 měsíci
The Essential Guide to Design & Configuration Specification
Becoming a Validation Pro: Unlocking the Master Plan
zhlédnutí 802Před 7 měsíci
Becoming a Validation Pro: Unlocking the Master Plan
VALIDATION PROJECT PLAN I CSV I COMPUTER SYSTEM VALIDATION
zhlédnutí 800Před 7 měsíci
VALIDATION PROJECT PLAN I CSV I COMPUTER SYSTEM VALIDATION
Guide to GxP Assessment for computerized system: In Pharmaceuticals
zhlédnutí 2,2KPřed 8 měsíci
Guide to GxP Assessment for computerized system: In Pharmaceuticals
Supplier or Vendor Assessment: Key Steps for Computer System Validation
zhlédnutí 918Před 8 měsíci
Supplier or Vendor Assessment: Key Steps for Computer System Validation
The Importance of URS in the Pharmaceutical Industry
zhlédnutí 1,5KPřed 8 měsíci
The Importance of URS in the Pharmaceutical Industry
Location bro
Plot No. Z104-106, Dahej SEZ II, Tal: Vagra, Dist. Bharuch. Gujarat
Operator ki Vacancies nahi hai kyaw
No
Informative
Thank you 😊
please dont put music
Yes sure
GDP: good distribution practice
yes
Sir iam chemistry student please
ok
It's not visible properly 😢
oh
❤❤
Thank you 😊
Your videos are helpful for me, Could you make a video about QMS. And also a video about day to day works of a CSV consultant.
Thank you 😊 Sure
make video on risk assessment
Sure
Very simple way explained and easily understanding, thanks
Glad you liked it
Content is good But don’t put any background music
Thank you. Yes, for my new videos, not using BG music.
Sir can you give detailed presentation on GMP
Yes, sure. Will try it ASAP.
ITI electrician
🤔
But please explain fully example
Sure
Nice
Thank you 😊
Fresher sathi ahe ka kuthe vacancy
No
Sir please prepair one video on effectveness monitoring.
Sure
Very helpful Thank you so much🎉❤
Thank you 😊
What is the difference between oos and OOL
OOS indicates quality issues with the product itself, when analytical results observe out of specification against an established specification limit., while OOL highlights a process control or monitoring concern, when any limits are observed out of limit against established limits.
Hallo, How can i contact with you ? Thank you
Hi, you can reach out at pharmaquality23@gmail.com.
Sir can you please forward the links in which we can download WHO ,GMP ,EU annex and FDA guidelines for manufacturing vaccine facilities... Please
cdn.who.int/media/docs/default-source/biologicals/gmp/annex-2-who-good-manufacturing-practices-for-biological-products.pdf?sfvrsn=995d5518_2&download=true#:~:text=URL%3A%20https%3A%2F%2Fcdn.who.int%2Fmedia%2Fdocs%2Fdefault www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice www.fda.gov/vaccines-blood-biologics/biologics-guidances/vaccine-and-related-biological-product-guidances
Sir how do you handle Discrepancy or Deviation encountered during the validation process, and what approach do you take to Resolve them....? Please answer sir..
During Qualification and Validation approach few organizations used Discrepancy term and few used Deviation term but more or less this is the same. Organisation used short kind of form or some automated tools to generate the discrepancy observed during the validation. Discrepancies during CSV should be documented, analyzed, and resolved promptly. Implement corrective actions, update relevant documentation, and conduct a re-validation. Will make on video soon.
Very good explanation
Thanks
I am having 9 years of experience in quality control department currently I am working in GLP and involving in instrument qualifications. How i will build my career into CSV.
Thats great you are having the experience in AIQ and I believe your practical experience and logic thinking, critical thinking, risk based thinking are required for CSV. Process knowledge and guidelines knowledge are very important to define the validation approach. I would recommend that you must have hands on experience for any system.
your videos are really helpful. thank you for your effort. But, i have a doubt regarding the last slide. 21 CFR Part 11 is not a guideline but it is a regulation.
Yes, you are right. 21 CFR Part 11 is a regulation, since it is part of the CFR issued by the FDA. Thank you so much for the correction. Everyone please consider this, and I apologise.
Thank you sir for very good explanation, In some situations operator not possible to enter manual data entries contemporaneously at the time of activity, In that scenario how data entered contemporaneously.
There are several ways to act on such situation based on the Quality head approval, few examples are below: 1. Assign the IPQA/Lab QA person to record the data along with operator and there should be the justification for such situation. 2. Some approved paper-based logs or annexure can be used to quickly enter the data and later can transcribed into data sheet/BMR etc. 3. If automated system is there then voicing recognition software can use to interface the data into the original software. And many more...
Good explanation
Thank you 😊
Sir change of supplier for excipients..means change control na ? Who should rise change control
When changing the supplier for an excipient, it should be managed through a change control process. Generally, it should be initiated by the QA and evaluate for potential risks and impacts on product quality and compliance.
Mail id kya hai
quality@alembic.co.in prodform@alembic.co.in apiproduction@alembic.co.in
Bhai freshers jaa sakte hai?
No freshers
How to extract plant names from pharmacopiae
Not getting what are you asking for? 😔
I want to learn line clearance Can you provide that
Will try to make a video on it.
Great info and easy way of teaching
Thank you 😊
Stop background music irritating
Thanks for the suggestion.
Bhai aap se connect kaise ho
You can connect at pharmaquality23@gmail.com
Very nice and your efforts are appreciated 🎉🎉🎉
Thank you so much 😊
Great explanation sir Very useful
Thank you 😊
Sir, Thank you for your very good explanation and Please tell me what is meant by regulated activity in pharmaceutical industry
In the pharmaceutical industry, we must follow rules made by government agencies like the FDA or EMA. These rules make sure that medicines are safe, work well, and are good quality. Following these rules is called regulated activity.
Can u please make a video on Equipment qualification of both API and Formulation and could you please also give references of multiple guidelines for qualification as well apart from CSV.
Thanks for the suggestion😊 Will make a video on it soon.
BGM disturbing..
Thanks for the suggestion. Now I'm careful about it.
So impressed...very nice
Thanks a lot 😊
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
Sure, will make on it.
Bsc microbiology any job available or not
No.
Any WhatsApp group? For Pharma Jobs alert for freshers?
Not for now. Sorry 😔
Can freshers apply?
No only experience
Check for freshers job czcams.com/users/shortsVe7E536l6w8?feature=share
Background music is distracting
Thanks for the feedback. Now I'm careful about it. 😊
Do video on QRM Sir
Sure, will make it on this topic. Thank you 😊
Sir ji your explanation is very easy for understanding
Thank you 😊
Thanks bro just need an examples
😊
So wonderfully explained
Thank you 😊