This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.
The new draft1 of Annex 1, Manufacture of Sterile Medicinal Products, was published on 20th December 2017, setting a milestone for adjustments needed within European agencies overseeing drug product regulatory applications. During the revision process, the US Food and Drug Administration (FDA) and the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC / S) worked alongside the EU, demonstrating the critical need for standardised regulations reflecting the current state of sterile pharmaceutical manufacturing on a global scale.
Most of the relevant principles of the ISO 14644-1:2015 standard2 are included in the new Annex 1’s Chapter 5.26. The minimum requirements needed to classify a cleanroom, including the initial number of sampling sites and the required sample volume in critical zones (Grade A and B) are now present in Annex 1. All further decisions must be based on process knowledge and risk assessment. Consequently, it will become difficult to justify why lesser parameters for the qualification are chosen, especially for inspection of manufacturing environment sampling. This ties in deeply with the statement in Chapter 5.28, where “Clean room qualification (including classification) should be clearly differentiated from operational process environmental monitoring”. A clear distinction needs to be made between each phase of a clean environment’s lifetime.
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