SOP on SOPs

The foundational SOP that governs how all your other SOPs, Policies, Manuals, and Forms are created, numbered, reviewed, and maintained - the document control backbone of your Quality Management System.

Who it's for: Virtual pharmaceutical sponsors setting up or standardizing their document control system across Policies, SOPs, Manuals, and Forms.

What's included:

• Document hierarchy (Manuals, Policies, SOPs, Forms) and numbering conventions
• 16 governing Standards covering document ownership, review cycles, approval signatures, and periodic review timing
• Full procedure for creating, revising, and obsoleting documents, plus the review and approval workflow and periodic review process
• Appendix 1: Required Elements - header/footer requirements and required sections by document type, in detailed reference tables
• Appendix 2: Document Numbering and Designations (department alpha codes, numbering scheme)

Format: Fully editable Word document (.docx).

Regulatory alignment: References 21 CFR 211.22 (Responsibilities of the Quality Control Unit).