Essential GxP SOP Package

Essential GxP Documentation Package

Everything a small bioanalytical lab needs to establish compliant documentation—without the enterprise price tag.

This package includes 5 foundational SOPs covering the core processes every GLP/GMP laboratory must have documented. Each template is written by a QC professional with 10+ years of hands-on experience in pharmaceutical CROs and biotech companies.

What's included:

• 5 Essential SOP templates in editable Word format
• Professional formatting that meets regulatory expectations
• Clear, audit-ready language based on real-world inspection experience
• Quarterly updates as regulations evolve

Perfect for:

• Startup biotechs building their quality system from scratch
• Small CROs needing compliant documentation quickly
• Labs preparing for their first GLP or GMP audits
• Contract labs expanding into regulated work

Why these templates work:

These aren't generic documents pulled from regulatory guidance. They're based on SOPs that have passed FDA and sponsor audits at multiple pharmaceutical companies. The formatting, section structure, and language reflect what inspectors actually expect to see.

Stop spending weeks writing documentation from scratch. Get audit-ready templates you can customize to your lab's specific processes in hours, not months.

Email support included—questions about customization or implementation? Just reach out.