Pharma Partners

By acquiring Pharma Partners we added an important element to our customer-oriented approach. Pharma Partners S.r.l. Officina Farmaceutica was born as a workshop of drugs secondary packaging and has been certified ISO 13485 for Secondary packaging of medical devices and diagnostic products in 2010. Recently, it has been authorized to the transformation from product sales to free sample and to the reworking of batches of secondary packaging.

SERVICE OF ADVICE ON GXP-ISO

  • SGQ implementation in GMP, GLP and GDP domains
  • Management of corrective and preventive action plans (CAPA plan)
  • Activity of Quality Assurance in outsourcing
  • Redaction of Quality Agreement
  • Redaction of Supply Terms
  • Quality Risk Management assessment & implementation
  • Technical training
  • Training activities for the personnel
  • Harmonisation of SGQ in multisite societies

REGULATORY SERVICE

  • Redaction of pharmaceutical recording dossiers for parallel imports
  • Management of communications to AIFA and product owners
  • PIF redaction (cosmetics)
  • Evaluation of the safety of cosmetic products
  • FT redaction (medical device)

AUDITING SERVICE

  • Audit at packaging materials and API suppliers
  • Audit at the production sites of partners and contractors
  • Audit at service suppliers
  • Training in operation for the customer personnel for auditing activities
  • Self audits
  • Management of the correlated CAPA plans
pharmapartners

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