Pharmacist Palash
By Palash Chandra Das
I have done M. Pharm in Pharmaceutical Medicinal Chemistry.
Industry Exposure : Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
a. Core Skill : Qualification and validation , QMS, Audit , Risk Management
b. Technology : Sterilization
c. Inspection faced: USFDA, TGA, MHRA, EU, ANVISA, INVIMA, PMDA.
Links,
1. Connect with me, www.linkedin.com/in/palashchandradas/
2. Browse Blog, pres.net.in/
Pharmacist Palash Jan 20, 2023
#05. How to Speak with USFDA Inspector ? Interesting learning
When Communicating with an Auditor, be careful what you say
a. Ask for Clarification
b. Stick to Your Expertise
c. Be Concise
Typical audit into 10 steps:
1. Selecting the site.
2. Contacting the site.
3. Arranging the visit.
4. Arriving at the site.
5. Showing data.
6. Interviewing personnel.
7. Conducting the exit interview.
8. Departure.
9. The report.
10. Outcome.
#04. Few controversial topics form Pharma Industry, need attention
Today I have discussed a few controversial topics from the Pharma industry. I know most of you will agree to my discussion but we never share our thoughts with anyone.
1. Training needs
2. Work Life Balance
3. Less attention to shop floor people , like analyst or operator
4. Multiple Manager , unorganized hierarchy
If you like our podcast please share to your friends or colleague
How to gain trust and confidence of Regulatory Inspector ?
I have shared few trick , How to gain trust and confidence in front of Inspector. Trust can actually be broken down into three main elements that I call the Trust Triad: competency, integrity and goodwill.
Regulatory Inspection Readiness : Importance of Communication
You and your team should strive to answer FDA's questions as directly as possible without providing unnecessary additional information. A good rule is to answer the question and then stop. If the inspector needs to know more, he or she will ask.
Identify subject matter expert of individual task and allocate the relevant activity.
US FDA inspection readiness : Part 1 - Qualification and Validation
I have work as Validation incharge for top Indian MNC. Participated in multiple inspections. This Podcast will help you to arrange relevant documents before or during inspection.
Example from Qualification and Validation role
- VMP
- Layouts Facility (simple, pressure ,classification, AHU, man-material movement), Utility
- Qualification planner (Equipment , utility , Media fill)
- Cleaning validation Plan , with matrix
- Protocol and Report to represent worst case Product
- Qualification SOP
- Initial Qualification and recent Validation
- Any Equipment
o URS
o DQ/ FDS
o 21 CFR
o OQ
o Risk Management
o PQ
o Recent Qualification
o Operating SOP
My Pharmaceutical Journey and Why I am here ?
This episode will give you a brief intro of my Pharmaceutical Journey so far. I am trying to help the entire pharmaceutical community with my experience.
In the year 2010 I completed my Master in Pharmacy with Pharmaceutical Chemistry . After that I have been associated with Pharmaceutical Industry and majorly I got exposure in Liquid and Lyophilized Injectable formulations for Potent ONCO products, General Injectables and Bacterial Vaccines.
I have been experienced in different roles and functions such as manufacturing & formulations, Qualification & Validations. I have participated as project coordinator for a few Green field and Brownfield projects of injectable manufacturing facilities.
I got the opportunity to face a few major regulations during audits like USFDA, TGA, MHRA, EU, ANVISA, INVIMA, PMDA.
As part of my hobby I do blogging, writing articles and have been associated with PDA for a couple of years.
That's all about the journey so far. Thank you.