GMP-certified analytical laboratory services

GMP-certified analytical laboratory: scope, compliance requirements, and what it guarantees for drug development partners

Every analytical result that ends up in a regulatory dossier makes an implicit promise. It says the result was generated by qualified people, on qualified instruments, using validated methods, within a quality system an inspector can reconstruct. When drug developers…
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GMP data integrity

Data integrity in GMP analytical laboratories: EU Annex 11, electronic records and audit trail requirements for pharmaceutical QC teams

During a Good Manufacturing Practice (GMP) inspection, Quality Control (QC) results are assessed together with the records behind them. Increasingly, those records are electronic, from chromatography data systems to Laboratory Information Management Systems (LIMS), and regulators expect their audit trails…
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