A comprehensive manufacturing solution tailored to meet your CDMO needs for both clinical and commercial production!
Our fully integrated GMP facility operates seamlessly at both 500L and 2000L scales. Backed by advanced analytical capabilities and impressive quality standards, we ensure excellence at every stage.
Contact us at collaborate@macrogenics.com.
#CDMO#Maryland
As government of India and Indian Drug Manufacturers' Association celebrates first ever National Good Manufacturing Practice Day with focus on improving quality of drugs💊. Here is very basic idea💡 of cGMP.
There are about 10,500 drug Manufacturing units across India,out of which only 2000 have World Health Organization (WHO) GMP certification.
✓cGMP refers to the Current Good Manufacturing Practice regulations.
✓cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
✓Adherence to the cGMP regulations assures identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
✓This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
✓‘C’ in cGMP stands for ‘current,’ requiring companies to use technologies and systems that are up-to-date in order to comply with the
regulations.
The reasons for GMP non-compliance are:
• Complex global regulations
• Compressed time to market
• Difficulty of GMP guideline interpretation
• Lack of uniformity between national and international guidelines
To overcome these non-compliance issues and to fill up the gaps it necessary that every pharma industry must train its employees.
The govt plans to observe Oct 10th as "Good Manufacturing Practice Day".
Let us all in the pharma industry use this day to reflect on what GMP means to us and how we can strengthen it every day.
At its core, GMP is a mechanism to build assurance that every single patient gets the right quality medicine every single time.
If that's what we want, that's what we must do.
Introducing zf-work-pharma: The Future of On-Premise Serialisation
Tired of relying on your equipment supplier's software and losing control over your serialisation processes?
Fed up with systems that won't integrate seamlessly, causing inefficiencies and workflow disruptions?
Frustrated by solutions that can’t adapt to your specific business needs, leaving you stuck with one-size-fits-all solutions?
zf-work-pharma, the ultimate answer to your pharmaceutical serialisation challenges:
🔹 Independent: Break free from dependency on equipment suppliers. Gain maximum flexibility and control over your serialisation processes.
🔹 Integrated: Connect effortlessly with your existing systems and streamline your operations for a smoother, more efficient workflow.
🔹 Adaptable: Customize zf-work-pharma to fit the unique requirements of your business, no matter the size.
Stay ahead of regulatory demands, enhance your supply chain integrity, and ensure patient safety with zf-work-pharma. Revolutionise your serialisation processes today!
💡 Learn more about how zf-work-pharma can transform your operations: https://www.zfabrik.de#PharmaceuticalSerialization#PharmaTech#SupplyChain#zfworkpharma#PharmaceuticalIndustry
Introducing zf-work-pharma: The Future of On-Premise Serialisation
Tired of relying on your equipment supplier's software and losing control over your serialisation processes?
Fed up with systems that won't integrate seamlessly, causing inefficiencies and workflow disruptions?
Frustrated by solutions that can’t adapt to your specific business needs, leaving you stuck with one-size-fits-all solutions?
zf-work-pharma, the ultimate answer to your pharmaceutical serialisation challenges:
🔹 Independent: Break free from dependency on equipment suppliers. Gain maximum flexibility and control over your serialization processes.
🔹 Integrated: Connect effortlessly with your existing systems and streamline your operations for a smoother, more efficient workflow.
🔹 Adaptable: Customize zf-work-pharma to fit the unique requirements of your business, no matter the size.
Stay ahead of regulatory demands, enhance your supply chain integrity, and ensure patient safety with zf-work-pharma. Revolutionise your serialisation processes today!
💡 Learn more about how zf-work-pharma can transform your operations: https://www.zfabrik.de#PharmaceuticalSerialisation#PharmaTech#SupplyChain#zfworkpharma#PharmaceuticalIndustry
Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale.
Try this ÄKTA system in 3D https://cytiva.link/fajey
Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale.
Try this ÄKTA system in 3D https://cytiva.link/fajey
Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale.
Try this ÄKTA system in 3D https://cytiva.link/fajey
Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale.
Try this ÄKTA system in 3D https://cytiva.link/fajey
Pharma Best Practices Webinar
Understanding Revised Schedule M Part II: Ensuring Compliance in Sterile Product Manufacturing
Here is the recording of the webinar.
https://lnkd.in/dx3r-NEQ
Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale.
Try this ÄKTA system in 3D https://lnkd.in/eYBQk_Di
Director of Intellectual Property at The Duke Human Vaccine Institute
3moReminds me of the work I was doing at @On Demand Pharmaceuticals around the corner in 2021.