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The implementation of EU GMP Annex 1, which sets strict requirements for the production of 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 not be completely eliminated from the aseptic process.
Although automation in aseptic production is progressing steadily, glove interventions will probably not be completely avoided in the foreseeable future, especially in high-speed systems. This is where 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 intensively discussed in the industry, as individual requirements require new solutions due to technical or physical conditions or are considered to be incomplete in individual cases. This applies, for example:
Annex 1 gives pharmaceutical companies a certain amount of room for manoeuvre, which they can use as part of a risk-based approach, for example in the context of CCS studies, in order to map and prove their processes in accordance with the rules. Generally valid solutions for implementation and implementation rarely come into play in practice, as they depend on customer and pharmaceutical requirements as well as the engineering and processing process that depends on them.
Operators of new or existing plants must demonstrate compliance with Annex 1 regulations to the authority inspectorate, so that new technical designs are sometimes required. Contract Development and Manufacturing Organizations (CDMOs), which 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.
