ANNEX 1

EU GMP Guide
“Manufacture of Sterile Medicinal Products”

Countdown to Annex 1 implementation date:

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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.

Annex 1 changes with EMA, WHO and PICs Contribution

Undergo a complete overhaul in collaboration with the EMA, WHO and the PIC/S*.

Revised several times, Annex 1 and contamination Control Strategy

One of the most extensive revisions since its implementation in the 1970s.

Annex 1 and Contamination Control Strategy

Published in December 2017 and revised again in February 2020.

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.

manufacture-of-sterile-medicinal-prodcutsa

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

Annex-1-EudraLex-Volume-4-EU-Guidelines-to-Good-Manufacturing-Practice

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.