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The implementation of EU GMP Annex 1, which sets strict requirements for producing sterile medicines, presents new challenges for pharmaceutical companies. In the foreseeable future, Ralf Wagner, Sales Director for the DACH region, Portugal and Spain at Optima Pharma, believes that glove interventions – especially in high-speed systems – will most likely remain part of the aseptic process.
Although automation in aseptic production is progressing steadily, glove interventions will likely remain a necessity in the foreseeable future, especially in high-speed systems. Camera systems provide valuable support, as the criticality of a process intervention and its potential impact on pharmaceutical quality can be assessed, evaluated and documented. High-speed cameras continuously record work processes and automatically store relevant sequences, such as when a system is stopped, or gloves are used. In this way, interventions can be analyzed retrospectively and their effects on pharmaceutical requirements and quality specifications can be assessed and documented.
The provisions of Annex 1 continue to be widely discussed within the industry, as certain requirements demand new solutions due to technical or physical conditions or are incomplete in specific cases. This applies to:
Annex 1 gives pharmaceutical companies a certain amount of leeway to use a risk-based approach, for example in the context of CCS studies, to map and demonstrate their processes in accordance with the rules. Generally valid solutions for implementation rarely come into play in practice, as they depend on customer and pharmaceutical requirements as well as the engineering and operational processes.
Operators of new or existing plants must demonstrate compliance with Annex 1 regulations to the authority inspectorate, sometimes requiring updated technical designs. Contract Development and Manufacturing Organizations (CDMOs) that process a variety of different pharmaceuticals rely on maximum flexibility. To this end, pharmaceutical manufacturers of selected products attach particular importance to the compatibility of new technologies.
