Falsified Medicines Directive (EU FMD) Audit Checklist
Falsified medicines directive audit checklist.
1 200 Skr
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Purpose:
Provides a structured audit checklist to support assessment of compliance with the EU Falsified Medicines Directive requirements, including verification, safety features, and supply chain controls.
Regulatory Alignment:
Aligned with EU Falsified Medicines Directive (Directive 2011/62/EU) and Delegated Regulation (EU) 2016/161, with relevant interfaces to EU GDP and EU GMP quality system expectations.
Included Files:
• EU FMD audit checklist
• Safety features and verification process assessment sections
• Observation, gap identification, and follow-up tracking fields
Format:
Microsoft Word or Microsoft Excel (fully editable)
Intended Users:
Pharmaceutical manufacturers, wholesale distributors, quality assurance teams, and auditors responsible for assessing compliance with EU FMD, GDP, and GMP requirements.