QUALITY ASSURANCE

• Interim Management:  e.g. Qualified Person §14 AMG

• QA-Projects: Change Control System, Deviation System,

• Product Quality Review

• Inspections / Audits

• Mock Up Audits

PHARMAPRODUCTION

• Interim Management: Production of sterile, solid, semi-solid forms and liquids

• GMP Upgrade

• Qualification & Validation:  Rooms – Machines – Personal

• Serialisation, Track&Trace

• Narcotic Management

• Implementation of good distribution practice

 

TEAM SUPPORT

• Projects in production and warehouse management:

   - replacement of production areas

   - optimization of personnel and material flow

   - qualification of rooms, equipment, machines

   - team education and training

   - implementation of Serialization or Track&Trace Systems

   - optimization of processes

 

• Projects of Quality Assurance:

   - change control and deviation systems

   - product quality review (PQR)