PIC/s GMP Proficiency


  • NPRA, Malaysia is one the earliest agencies to secured PIC/S membership in January 2002, well ahead of most of the emerging markets.
  • The NPRA issued PIC/S GMP license is well acknowledged by Ukraine, Thailand, Singapore, Taiwan, Hong Kong, Turkey, Argentina, Mexico etc.
  • Metina expedites product triggered GMP inspection through NPRA by application submission through Quest 3, support in screening deficiencies, fees payment and BE/CMC evaluation deficiencies response.
  • The service encompasses scientific writing of dossier in ACTD format, drug product classification and support till approval.
  • PIC/S GMP inspection service would cover submission of request letter, inspection dates finalization with inspection committee, preparing manufacturing site as per PIC/S GMP guide, CAPA submission till site licensing.
  • Metina also support BE/Clinical Center GCP inspection and approval through NPRA.
  • In addition, Metina offers Holding and Maintaining Marketing Authorisation with NPRA and Identifying importer / distributor post approval for product marketing.

PIC/S GMP Proficiency - Case Study

Read what to look for PIC/S GMP