#cleaning validation

[cleaningvalidation]

Single source for all topics on cleaning validation. Read monthly memos by Destin LeBlanc on cleaning validation or join our forum or see how eResidue Pro will simplify your workflow

[quascenta]

eResidue Pro by Quascenta can assist you in maintaining a compliant cleaning validation programme. The software seamlessly integrates all the cleaning validation data under a single umbrella thereby improving not only productivity but also acts as an aid in better decision making from the integrated data available on demand.

[indigonite]

There’s a lot you can learn about it, trust me

[ihspl]

Indivirtus Healthcare Services

As a Contract Research Organization (CRO), Indivirtus Healthcare Services offers a wide range of services within the pharmaceutical and healthcare sectors. Initially, the company specialized in delivering Toxicological Risk Assessment Reports to pharmaceutical manufacturers. However, over time, it has expanded its service offerings to include numerous other services.

Established in 2018, Indivirtus Healthcare Services began its journey in a modest single-room office, staffed by just two individuals, led by Dr. Upendra Jain and Ms. Veena Kumari. Over the span of six years, this humble organization has evolved into a group of five companies, boasting seven offices worldwide and a workforce of over 100 employees. Indivirtus Healthcare Services has successfully served more than 500 clients across over 45 countries.

The range of services provided by Indivirtus Healthcare Services includes:

Toxicology:

Toxicology is the scientific field that involves the study of the harmful effects of chemicals on living organisms.

Cleaning Validation: This service ensures cleanliness to prevent contamination during production processes. It is achieved by calculating MACO (maximum allowable carryover) values based on health-based exposure limits such as PDE (Permitted Daily Exposure), ADE (Allowed Daily Exposure), and OEL (Occupational Exposure Limit), all established through thorough risk assessments. These reports adhere to guidelines set by EMA, ICH, APIC, AND PICS.

Genotoxic Evaluations of Impurities: Utilizing ICH M7 guidelines, this service assesses the genotoxicity and mutagenicity of impurities to determine their acceptability in drug substances and products.

Material Safety Data Sheets (MSDS): These provide detailed information on the safety and handling of materials.

GRAS Reports: These confirm the safety of substances for their intended use.

Regulatory Affairs/Regulatory Affairs (RA/Reg Affairs)

Preparation and Submission of CTD, ACTD & e-CTD Dossiers

Dossiers for Regulated, Semi-regulated, and WHO Regulated Market

CEP Filing & Submission on the EDQM Portal and DMF Filing to the FDA

Clinical & Non-Clinical Overviews and Summaries

Batch Releasing & Testing Site Service for Europe (BRS & BTS)

MAH & Local Agent Service for Europe & US

Pharmacovigilance and Drug Safety Services

PSMF Management

Single Case and Adverse Event Reporting

Aggregate Report Generation

Safety Physicians Support

Signal Management & Safety Surveillance

Literature Monitoring (Global and Local)

Medical Writing

Risk Management Plans (RMPs)

Electronic Submission Management

Medical Information Call Centre (MICC)

Qualified Person for Pharmacovigilance (QPPV) Support

Regulatory Authority Requests and Audit/Inspection Readiness

Social Media Monitoring for Adverse Events

Calibration Services

Indivirtus Healthcare Services is equipped to provide a variety of calibration services through a facility accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) (ISO/IEC: 17025:2017). Our calibration services cover a broad spectrum, including:

Calibration Facility in various dimensions, pressure, mass, volume, RPM, sound, electro-technical, and thermal.

Temperature Mapping and Validation Facility for Furnace, Chambers, Oven, and Cold Storage.

On-site Facility for Calibration.

Training on Quality Systems & Implementation.

Computerized System Validation (CSV)

Indivirtus Healthcare Services is dedicated to providing comprehensive services in CSV to ensure that systems are performing their intended tasks effectively. Our CSV services include:

Implementation and Validation of Computerized Systems.

Decommissioning of Computerized Systems.

Cloud Systems Validation.

Quality Systems for IT Departments and IT Service Suppliers.

Quality Systems for Software Validation.

Computer Infrastructure Qualification.

Audits for IT Solution Suppliers.

Training.

Clinical Research & Equivalence Studies

Indivirtus Healthcare Services provides a range of clinical research services, including feasibility assessments, participation in regulatory discussions, project oversight, management of clinical sites, handling of data and statistical analysis, and the conduct of Phase I, II, III clinical studies.

Technology Transfer (Tech Transfer)

Indivirtus Healthcare Services specializes in technology transfer services, facilitating the transition of drug substance production processes from research laboratories to commercial facilities. Our services include CMO (Commercial Manufacturing) site transfers and CMDO (Research and Development to Commercialization) services. We handle various aspects of technology transfer, such as:

Site transfers

Research and Development/Funding and Development

Dossiers/Know-how

Good Manufacturing Practices (GxP) and Auditing Services

Indivirtus Healthcare Services offers a variety of audit services to help identify and address deficiencies in processes, ensuring compliance. Our audit services include:

Internal audits and Good, Environment, Management, and Business Analysis (GEMBA) sessions

Third-party audits and Gap assessments

Pre-inspection and Due Diligence audits

Additional Services Provided by Indivirtus Healthcare Services include:

CMO/CDMO Facilities for the Sourcing of Formulations and Active Pharmaceutical Ingredients (APIs)

Greenfield/Brownfield Development Projects

[jsapharmaguideline]

Laboratory Instrument Qualification Protocol: Ensuring Accurate and Reliable Results

In the world of pharmaceutical manufacturing, maintaining precise control over every step of the process is paramount. Laboratory instruments play a critical role in ensuring the quality and safety of medications. To guarantee these instruments consistently deliver reliable results, a well-defined laboratory instrument qualification protocol is essential.

[memoriesndew]

let's reset

I've been feeling less like myself lately, unmotivated, overeating, and just lazy. so I'm taking it upon myself to reset, just to get back into routine.

my goals during this reset are to:

fix my sleep schedule

conquer the 75 hard habits

re-focus myself on my goals

study often

find a daily routine

romanticize my life

I'll be using @bloomzone's posts to do this, and I'll try to update every day.

🍒: really short post hnmm.

[n1pp]

Édouard Boubat // "You cannot live when you are untouchable. Life is vulnerability."

[bloomzone]

in these moments, I remind myself and also remind urself that it’s okay to take things one step at a time. Everyone goes through the feeling of that I’m behind or falling short. It's a feeling I’m not alone in it even if it seems like it sometimes. It's okay to not have everything figured out right now. The journey isn't a straight line, and the pressure to be perfect, to be ahead, or to be constantly doing something can be overwhelming, but it doesn’t define us .

I also remind myself that fear is normal. Fear of not being enough, fear of failure, and fear of missing out on opportunities it’s part of being human. The doubts that creep in, those moments when I question my abilities, they’re not the end of the story they’re just obstacles, and I can rise above them. What matters isn’t how many times I stumble or doubt myself, but how I rise each time and move forward with courage, even if it’s a small step. I may not always feel confident or capable, but that doesn’t mean I’m not worthy of success or happiness. I am learning and growing, and that’s what matters. Progress takes time. I don’t need to have it all together today because every day is an opportunity to learn, improve, and get closer to where I want to be.

Fear doesn’t define me, my doubts don’t define me. My actions, my persistence, and my determination THAT'S what defines me. I’m allowed to be imperfect, and I’m allowed to grow at my own pace and u too , there’s no timeline I have to follow, no need to compare myself to others. I trust that I’m exactly where I need to be, and the time I have is enough. I have everything within me to overcome the fear, to move past the doubts, and to make the most of the time that I have. Every little step counts, and I’m doing great and you too u are doing great , even when it doesn’t feel like it. The future is waiting, and u and I are on the right path.

@bloomzone 📓✒️

[ros3ybabe]

First Impressions 🎀

I've had 4 of my 5 classes so far (one doesn't start til october) and I definitely have some thoughts on them, so I thought I'd share my first impressions!

Principals of Accounting II:

the professor seems a bit disorganized, nervous, and semi chaotic but I like his energy

so many people in southern attire, I was a bit surprised

might take a decent amount of study time and energy to keep my grade up in the class, but I'm always up for a challenge and I definitely know I'm capable

gotta figure out a time efficient study routine for this class

Learning (Psychology)

professor has an accent, no idea where he's from, but it's a cool and thankfully understandable accent

feels very content heavy. I definitely want to buy the textbook for this class

need to find a way to stay awake, that's one of the classrooms that make me sleepy

that professor likes to talk for sure (1 hour and 15 min of just the syllabus? man's can talk)

Integrated Survey of Organic and Bio Chemistry

the professor is definitely a science guy, him being the professor makes perfect sense

i really like how he explains and teaches

appreciate that all the content needed is already posted to our class online and all the slides are available already

I love science based classes because I know how to succeed in them and this one seems no different

I have a friend in the class so that's nice!

Intro To Business (Online)

lots of content

lots to do

I gotta make sure I time manage for this class cause otherwise, I'm gonna fall behind

an introduction video?? why not just a discussion post?? ahhhhh

Overall, with working full time, this is going to be an incredibly stressful, incredibly busy semester, but I'm so up for the challenge, and I know I can do it. I just gotta study efficiently, time manage properly, and keep disciplined. I WILL be successful.

til next time lovelies 🩷

[littletroubledoll]

[quascenta]

eProcess Pro by Quascenta is a game-changing, intelligent, lifecycle-based guided process validation platform that understands and speaks your language. It empowers consistent product excellence by seamlessly managing design, manufacturing, and safety, ensuring compliance and instilling confidence in your pharmaceutical initiatives.

Process Performance Qualification Software | Process Validation Software | Continued Process Verification Software | CPV Software | Annual Product Quality Review Software | APQR Software | Process Analysis Software | Process Insight Software | Validation Lifecycle Software | Data Analytics Software

[vanilllagirlss]

[the-way-astray]

guys i really hate to break it to you, but elves would not consider the moon landing to be a particularly outstanding achievement

[jsapharmaguideline]

Laboratory Instrument Qualification Protocol: Ensuring Accurate and Reliable Results

In the world of pharmaceutical manufacturing, maintaining precise control over every step of the process is paramount. Laboratory instruments play a critical role in ensuring the quality and safety of medications. To guarantee these instruments consistently deliver reliable results, a well-defined laboratory instrument qualification protocol is essential.

[memoriesndew]

that clean girl vibe

pretty, clean, and smells good....

[sparklykat-hideoutenthusiast]

*exhausted sigh*

:(