Since the new Annex 1: Manufacturing of Sterile Medicinal Products has been published, no one in the pharmaceutical industry can ignore it.
For all companies that manufacture sterile pharmaceutical products, having a Contamination Control Strategy is a requirement.
Although Annex 1 mentions many aspects that must be described in such a Contamination Control Strategy, the annex provides little guidance on how such an important document should be written. This one-day course provides guidance on drawing up and keeping the Contamination Control Strategy up-to-date.
In addition, various aspects of producing sterile products are discussed, such as cleanrooms, water, gases, sterilization, environmental monitoring and medium simulations. Attention will also be paid to possible risks for sterile products.
