QP-Services

  • QP declarations
  • Batch record review
  • API release
  • API and excipient assessment according to Dir. 2001/83/EC and part II of the EU GMP Guideline
  • Formalised risk assessments according to 2015/C95/02
  • Bulk release
  • Drug release
  • stability OOS evaluations
  • Deviation Evaluation – CAPA Management
  • Complaint Management
  • QP Training and coaching

 

  • Product Quality Reviews/Annual Product Quality Reviews (PQR/APQR)
  • Periodic safety update reports (PSUR)

 

  • API and drug import and QP release of products from outside the EU

 

  • Supplier inspections