REGULATORY COMPLIANCE SUPPORT

PIC/S (Pharmaceuticals Inspection Co-operation Scheme)

PIC/S Checklist

  • Document History
  • Introduction
  • Scope
  • Content of Site Master File
    • General Information on the Manufacturer
    • Contact Information on the Manufacturer
    • Authorised Pharmaceuticals Manufacturing Activities of the Site
    • Any Other Manufacturing activities carried out on the site
    • Quality Management System of Manufacturer
    • The Quality Management System of Manufacturer
    • Release Procedure of finished products
    • Management of suppliers and Contractors
    • Quality Risk Management (QRM)
    • Product Quality Reviews
  • Personnel
  • Premises and Equipment
    • Premises
    • Equipment
  • Documentation
    • Type of Products
    • Process Validation
    • Material Management and Warehousing
  • Production
  • Quality Control (QC)
  • Distribution, Complaints, Product Defects and Recalls
  • Self-Inspection

 

Countries in PIC/S

• Argentina• Denmark• Poland• Sweden
• Australia• Estonia• Portugal• Switzerland
• Austria• Finland• Romania• Thailand
• Belgium• France• Singapore• Turkey
• Canada• Malta• Slovak Republic• Spain
• Chinese Taipei• Mexico• Norway• Ukraine
• Croatia• Netherlands• Slovenia• United Kingdom
• Cyprus• New Zealand• South Africa• U.S.A
• Czech Republic• Norway• Spain