Quality Assurance Services

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Basic Pharma can assist you in the development, maintenance and update of your Quality Assurance System and Quality Assurance Handbook.

The following services can be offered:

  • Support and advice in the application for a Wholesalers Licence and a Manufacturing/Import Licence
  • Compilation of Standard Operating Procedures and QA-documents in accordance with GDP (Good Distribution Practice), current GMP (Good Manufacturing Practice) and GCLP (Good Control Laboratory Practice)
  • Due diligence of the QA-system and QA-handbook
  • Compilation of a Site-Master-File in accordance with PIC-requirements
  • Batch-release services and batch-certification services (services of a Qualified Person for GMP)
  • Auditing and monitoring services for API-manufacturers, Finished Product Manufacturers, Control Laboratories and Warehouses
  • GDP/GMP-training