The issue of the new revision of the EU GMP Annex 1 for sterile production is approaching, and the current draft is already acknowledged as an important challenge for the quality system of any pharmaceutical sterile production. One of the most important implementations that will be required is the issue of the site Contamination Control Strategy document, a 360-degrees plan of the controls, procedures and technologies for the containment of the contamination risk of products and processes.
How can such a high-level documentation be designed, assessed and issued?
In this webinar PQE experts will guide you into the understanding of the main sources of contamination and the related control and design measures to be applied as contamination control within your facility from Microbiological and Engineering Prospective: a dedicated focus on Barrier technologies, monitoring systems and sterile components handling will be provided.
Let’s talk together about regulators and industry expectations, when no guidelines and benchmarks are available for such an overriding task.