Business Lineup

Business Lineup

Engineering / Validation

The Governer of Tokyo Construction Work Contractors License No. (HAN-26) 142165

  • Contracted installation of machine/equipment
  • Establishment of production/manufacturing/packaging line(from basic design to validation)
  • Relocation of production/manufacturing/packaging line (from operation check to validation)
  • Various modification work (including validation)
  • Qualification and Validation of GMP facilities
    (PIC/S-GMP・WHO-GMP・cGMP・EU-GMP・ICHQ9「QRM」・ISPE Vol5「C&Q」)
  • Compliance to ER/ES・GAMP5・Computerized system validation guideline
  • Support in GMP/GQP documentations
anple

Consulting / Seminar

General Worker Dispatching Undertakings License No. HA13-304694

Exclusively contracted with Pharmacs Japan (GMP experts from PMDA)

  • PIC/S-related seminars, assessment and pre-audit advice, performed by GMP experts from PMDA
  • Seminars on GMP compliance check, by GMP experts from PDMA
  • Instruction and guidance about PIC/S-compliant GMP globalization
  • Instruction and guidance about PIC/S・CSV guideline
  • Seminars on PIC/S・CSV guideline
  • Instruction and guidance about FDA/EMA-compliant GMP audit
ptp

Instruments

  • GS1 Module controller (HIES-3000)
  • GS1 Code inspection・matching・verification system
  • Code128 Label generator
  • Specialized inspection devices (Pulsed x-ray inspection system, Inspection of silicone presence inside barrel)
  • Data management system (ER / ES-compliant)
  • Various clean unit
  • Others (RFID Control System, Monitor Recorder, LED lights and power supplies)
Laetus
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