Pharmaceutical Insights & Expert Guidance

Common findings: shared login credentials, disabled audit trails, reprocessing chromatographic data without justification.

MHRA expectation: Full ALCOA+ compliance across all GxP operations.

Update batch certification procedures and review quality agreements with overseas sites.

UK medicine spending projected to rise from 9% to 12% of health spending.

UK biopharma turnover: 98.9bn. Risk-based inspection frequency depends on compliance history.

All storage areas must be temperature mapped with continuous monitoring.

Review existing risk assessment procedures. Train teams on updated principles.