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This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.
The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…
