Serialisation of Pharmaceutical Production

Fast, Flexible, High Quality and On Budget

BACKGROUND

• To fulfill regulatory requirements in regards to Directive 2011/62/EU and other similar legislation worldwide

• Full supply chain coverage: own sites, CMO’s & distributors

• IT systems upgrade (SAP integration)

Benefit

• Implementation of Serialisation in compliance with authority requirements

• Implementation of Serialisation on time at multiple production sites / CMO’s

• Coordination/Interaction with key stakeholders ✓ Deliver within budget

• Scope changes absorbed within timeline (M&A impacts)

Services

• Project management

• Specification of serialisation and aggregation equipment for packing lines

• Procurement and contract management

• Implementation of Anti Tamper Device (ATD) on each Sales Unit

• Validation and qualification of equipment, packaging materials and print • Documentation and hand-over to line-ofbusiness

• Coordination with client staff: user representatives, EHS, logistics, technical specialists, procurement, finance, IT, QA etc.

CONTACT FOR THIS CASE

Anders Helmer Nielsen

Mobile: +45 5099 8328
Email: ahn@amgroup.dk