"If a stability study fails at month 12, re-baseline to month 6."
Procedures for internal quality audits , quality management reviews, and managing Planned Modifications . pharma devils sop
Post-COVID, remote audits became common. The Pharma Devils SOP exploits this. One notorious procedure instructs staff to use "dynamic camera angles" during a live video audit of a cleanroom. When the auditor asks to see the HEPA filter diffuser, the camera operator pans to a wall. When asked to see the batch record signatures, the operator holds the page so the thumb covers the time-stamp showing the signature was added three days after the manufacturing date. "If a stability study fails at month 12,