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Quality at LU-PI

Quality

Quality is built into the process following the  procedures. The procedures provide for:
  • Execution of manufacturing operations according to master batch record approved by QA.
  • Use of suitable and qualified equipment
  • Implementation of preventive maintenance according to the plan.
  • Use of scientifically sounded  cleaning procedures.
  • Investigation and corrective actions for out of specification data.
  • Management of changes.
  • Initial tutoring  and operators on-going training.
Quality is verified during and at the end of the process  through:
  • Quality assessment of  raw material, final intermediate and API
  • Verification of cleaning  effectiveness
Quality is assured over time
  • Consistency of the cleaning and manufacturing processes is verified during  validation and  periodically monitored by QA group and documented in  the Annual Product Review.
  • Facilities and Procedures are regularly inspected by national and foreign authorities but also frequent audits are performed by customers with positive outcome.
Analytical controls and stability studies are made in the QC Laboratory, equipped with state-of-the-art instrumentation:
  • FT-IR
  • HPLC with diode array
  • GC-MS, LC-MS
  • Stability chambers operating under ICH conditions
  • NMR, DSC, Particle size analyser
  • Using validated analytical methods

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

 

 
 

 

 
LUPI
Lundbeck Pharmaceuticals Italy S.p.A.
Via Quarta Strada 2
35129 Padova - Italy
Tel +39 049 8699311
Fax +39 049 8077146
lupi@lundbeck.com
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