Certifications
-
Certifications
- ISO 9001 Certification – QMS
- ISO 14001 Certification – EMS
- ISO 45001 Certification – OHSMS
- Safety Schemes in Procurement (SSIP)
- ISO 27001 Certification – ISMS
- ISO 22000 Certification – FSMS
- ISO 50001 Certification – EnMS
- End of Waste: Scrap Metal and Copper
- ISO 13485 Certification – MDMS
- EFfCI Certification
- EXCiPACT Certification
- GNI – Global Network Initiative
- Customer Service Transparency Standard (CSTS)
- Operation Clean Sweep (OCS)
EXCiPACT Certification
Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry.
EXCiPACT is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.
How it works: An ISO 9001:2015 approved excipient supplier contracts with A Cube TIC Limited (EXCiPACT-approved independent third party Certification Body) agrees the audit scope and standard to be used (GDP, GMP or both).
If the audit shows compliance, A Cube TIC Limited provides them with an EXCiPACT certificate and audit report. Certification is valid for three years, includes annual surveillance audits, and as for all Certificate Holders, it is verifiable on the EXCiPACT website.
How it works: An ISO 9001:2015 approved excipient supplier contracts with A Cube TIC Limited (EXCiPACT-approved independent third party Certification Body) agrees the audit scope and standard to be used (GDP, GMP or both).
If the audit shows compliance, A Cube TIC Limited provides them with an EXCiPACT certificate and audit report to share with their customers (users). Certification is valid for three years, includes annual surveillance audits, and as for all Certificate Holders, it is verifiable on the EXCiPACT website.