Annex 1 (2022) – The Brave New World of Regulatory Compliance
After six years in review, the final emergence of Annex 1 in August 2022 has either been a consolidation of accepted practice and wisdom or a rude awakening for many! However, it is universally accepted that it is decades' most significant single change to regulatory approach. As Annex 1 deals with products made in Europe, or products intended for Europe, it is likely to have a significant international reach. Indeed, the narrative within Annex 1 has already been adopted by PIC/s, and with the close links to WHO and FDA, it will undoubtedly soon have a global reach. However, the regulatory bodies have also indicated a harsh stance on the implementation date - the regulatory view emerging is that the Annex contents should not be a surprise at this stage! Many companies now realize that a particular vintage's existing facilities may not comply with the new requirements. And time is running out.
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