GMP Annex 1 Update: New Requirements
The new version of EU GMP Annex 1, a regulatory standard governing sterile pharmaceutical products, is published in August 2022. This is a revision of the 2020 and 2008 versions. It will come into force on 25 August 2023.
The update of GMP Annex 1 introduces changes to the strategic control and quality measurement applied to pharmaceutical manufacturing. The revision also brings the manufacturing principles contained in Annex 1 into line with those of the World Health Organization (WHO).
The new version contains a rewording of Annex 1 from 2008, but with a fourfold increase in length. The document is divided into 10 sections. The major changes are as follows:
- The separation and differentiation of Certification and Monitoring: the guidelines on the design and qualification of premises and routine monitoring have been extended;
- The concept of Contamination Control Strategy (CCS), which is used as a holistic approach to analyse the interaction between the various aspects of contamination and the facility as a whole;
- The identification of quality risk management as an approach to defining processes, operations and limits.
In addition, the revision of appendix 1 aims to reduce manual operations and optimise the separation between the operator and the product in order to reduce batch contamination. Section 2.1 states that the use of appropriate technologies such as isolators or RABS systems is essential to optimise product protection.
The Challenges of New Safety Standards in the Pharmaceutical Industry
In the wake of the pandemic crisis, France is aiming to become the most innovative pharmaceutical industry in the world. To achieve this objective, the industry needs to respond to a number of challenges:
- Optimising the anticipation and management of health risks by empowering staff through the sharing of best practices;
- Acquiring skills in purification, analytical development, process engineering, risk anticipation and management, and quality control;
- Securing all phases of the certification process by coordinating all site functions;
- Automating processes to protect products from contaminants, optimise quality, increase productivity and shorten validation times.
To comply with the new requirements following the update of GMP Annex 1, choose the solutions offered by specialist MGA Technologies.
Updating GMP Annex 1: moving towards pharma 4.0 with MGA Technologies
It is entirely possible to have robotic solutions without breaching sterility conditions. Call on MGA Technologies, the expert in industrial robotics. To comply with the updated GMP Annex 1 and to support you in your transition to pharma 4.0, MGA is able to provide you with tailor-made robots and machines for the pharmaceutical industry. Our solutions are designed to perform repetitive tasks in highly confined and sterile conditions. They can be deployed to carry out various sterile and repetitive processes, such as the distribution of diagnostic tubes, the marking of vials, sterile connection and disconnection, the impregnation of a pharmaceutical process liquid, etc. Our robotic solutions and equipment for sterile environments comply with good manufacturing practices and other applicable standards.
Find out more about our products by contacting our engineers.