ANNEX 1
EU GMP Guide
“Manufacture of Sterile Medicinal Products”
We are here to help you meet the new requirements with compliant software solutions
The Annex 1 is considered to be the most important European regulatory standard for the manufacture of sterile pharmaceutical products.
Undergo a complete overhaul in collaboration with the EMA, WHO and the PIC/S*.
One of the most extensive revisions since its implementation in the 1970s.
Published in December 2017 and revised again in February 2020.
Regulatory requirements in the pharmaceutical industry are expected to increase further. The changes made in the revision of Annex 1 show, that developments in manufacturing and testing as well as quality risk management principles, are now more extensively taken into account.
By Stephen Smith
Global Pharmaceutical Consultant for Quality Compliance
CHALLENGES FOR THE INDUSTRY
Quality Risk Management
Contamination Control
Process Mornitoring
Novatek Solutions
Cleaning Validation Software
Minimizing the risk of microbial, particulate and pyrogen contamination and therefore ensuring the sterility of the manufactured products.
Environmental Monitoring Module
Environmental monitoring, aseptic process simulations.
As one of the world’s leading pharmaceutical software suppliers within Pharmaceutical and Bio Pharmaceutical, Novatek is well-positioned to address the topics outlined within the draft paper. Novatek will continue to actively track the development of Annex 1 to ensure continued compliance of our systems and processes.
Monitoring the development of Annex 1 extremely closely
Evaluating the implications surrounding compliance
Assessing the implications once the final version is published
Allowing our customers to prepare with minimum disruption for the expected changes laid into effect for 2022
One of the world’s leading pharmaceutical software suppliers within Pharmaceutical and Bio Pharmaceutical.
Well-positioned to address the topics outlined within the draft paper.
Continue to actively track the development of Annex 1 to ensure continued compliance of our systems and processes.
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