Quality Policy (GMP) - Virtual Sponsor of Clinical Program

A top-level Quality Policy that defines your virtual company's Quality Management System (QMS) - the master document that ties together your GMP, GDP, GCP, GLP, and GVP procedures.

Who it's for: Virtual pharmaceutical companies engaged in development and commercialization of human drugs, using contract manufacturers, laboratories, packagers, and distribution providers.

What's included:

• Purpose and Scope of the Quality Management System
• Responsibilities across Senior Management, the Quality Unit, and All Employees
• QMS Documentation overview, referencing your SOP on SOPs, Data Integrity, Good Documentation Practices, and Training SOPs
• Vendor Management and Batch Release overview, including Quality Agreements and CMO/CRO oversight
• Definitions and Abbreviations (ALCOA+, CMO, CRO, Quality Agreement, GXP)

Format: Fully editable Word document (.docx).

Regulatory alignment: Built around ALCOA+ principles and covering GCP, GDP, GLP, GMP, and GVP requirements.