PHARMACEUTICAL SUPPLY CHAIN INITIATIVE
WHAT IS PSCI AND RELEVANCE TO PHARMACEUTICAL AND HEALTHCARE SECTORS?
The PSCI was formed in 2006 and now become a group of 79 global pharmaceutical companies (members) who have committed to drive shared vision for excellence in safety, environmental, and social outcomes for the whole of the global pharmaceutical and healthcare supply chain. PSCI has created the PSCI Principles for Responsible Supply Chain Management, known as the Principles, to articulate what the industry expects from the supply chain driving sustainable development goals (SDGs) and support conformance with market regulations such as The German Supply Chain Due Diligence Act, EU-CSRD and similars.
PSCI PRINCIPLES:
These Principles address five areas of responsible business practice
■ ETHICS
■ HUMAN RIGHTS & LABOR
■ HEALTH & SAFETY
■ ENVIRONMENT
■ MANAGEMENT SYSTEMS
AUDIT PROGRAM
The PSCI audit program covering above five principles either full or partly (HSE, Ethics, Labor, Management System) as per company supply chain responsible sourcing strategy. The PSCI audit is a testament for suppliers to demonstrate their commitment and conformity with sector specific sustainability standards in the pharmaceutical industry.
WHO CAN INITIATE THE AUDIT?
The supplier can contact their customer who in turn are PSCI member company to sponsor an PSCI audit. Alternatively, a company may nominate themselves to the PSCI Secretary requesting that they be audited under the self-paid model.
HOW THE SUPPLIER CATECGORIZATION DONE?
The suppliers are categorized according to their activities:
Category "A": Service providers and suppliers of non-supply chain goods.
Category "B": Component & material suppliers.
Category "C": Core suppliers & contract manufacturers, for e.g. Intermediate, API, Foumulation.
PSCI AUDIT PROCESS
THE PSCI Audit follow 5 step process.
PREPERATION
■ Complete self assessment quessionnaire (SAQ)
■ Share audit plan
CARRYING OUT AUDIT
■ Opening meeting
■ Site tour
■ Interview with management and employees
■ Review of documents and records
■ Pre-closing meeting
■ Closing meeting
AUDIT REPORT AND CORRECTIVE ACTION PLAN
■ Audit report in standardized template
■ Summary of positive and negative findings
■ Corrective action plan agreed upon by the auditor and supplier
SHARING THE PSCI AUDIT
■ Data sharing agreement
■ All or selected PSCI members
CAP FOLLOW-UP
■ Agreed timeline
■ On-site or Off-site
■ Follow-up audit report
CETIZION VERIFICA ACCREDITED AUDIT
We are approved to conduct PSCI audit in India covering all the 3 categories (A,B,C) for all the five principles.
Management systems, Labor and Ethics:
Yes (Supplier type: A, B, C)
Management systems, Health & Saftey, Environment:
Yes (Supplier type: A, B, C)
YOUR BENEFITS WORKING WITH CETIZION VERIFICA
1. High standard of Integrity and data confidentiality.
2. Price competitiveness.
3. Faster delivery: Shorter Lead time for audit scheduling and audit reporting.
4. Team experienced in PSCI Auditing since early stage of PSCI program roll-out.
5. Average 24+ year of audit experience with world leading companies in manufacturing and Auditing.
6. Practical and realistic approach.
OTHER SERVICES FOR PHARMACEUTICAL AND HEALTHCARE INDUSTRY
■ Environment management system ISO 14001
■ Occupational Health & Safety Management System ISO 45001
■ Energy Management System ISO 50001
■ Information Security Management System ISO 27001
■ Anti-bribery Management System ISO 37001
■ Water Audit
■ Energy Audit
■ Greenhouse Gas (GHG) emission verification ISO 14064 (scope 1, 2, 3)
■ Assurance of Sustainability Reporting (BRSR/GRI/IR)
■ Zero Liquid Discharge (ZLD) Certification
■ Zero Waste to Landfill (ZWL) Certification
■ Solvent Recovery System (SRS) Certifications
■ Suppliers (Tier 1, 2, 3) ESG assessment
GAP ASSESSMENT