Professional GxP SOP Package

Stop reinventing the wheel. Start with audit-ready SOPs.

Building a compliant quality system from scratch takes months—sometimes years. Regulatory agencies don't wait, and neither do your clients.

This package gives you 15 professionally-written Standard Operating Procedures covering the complete GxP framework that auditors expect to see. Written by a Quality Control Supervisor with 10+ years of GLP/GMP experience at leading pharmaceutical CROs and biotechs.

What's Included

15 Comprehensive SOPs:

Foundation Documents

• Document Control & Management
• Training Program
• Deviation/Non-Conformance Handling
• CAPA (Corrective & Preventive Action)
• Equipment Maintenance & Calibration

Quality Operations

• Change Control
• Batch Record Review
• Laboratory Notebook & Data Recording
• Sample Management & Chain of Custody
• Method Validation/Verification

Advanced Compliance

• Out-of-Specification (OOS) Investigations
• Stability Studies
• Environmental Monitoring
• Supplier/Vendor Qualification
• Internal Audits

Plus:

✓ Advanced templates – Ready-to-use forms and attachments referenced in each SOP

✓ Priority support – Direct email access for implementation questions

✓ Monthly updates – Receive updated versions as regulations evolve

✓ Training materials – Quick-reference guides to train your team

Perfect For

• Growing biotechs preparing for their first regulatory inspection
• Contract laboratories expanding into GLP or GMP testing
• Quality managers building a compliant system without starting from zero
• Startups who need enterprise-level documentation on a startup timeline

Why These SOPs?

Every SOP in this package addresses areas that auditors consistently review:

→ FDA 483s frequently cite inadequate training documentation—our Training Program SOP closes that gap

→ Deviation and CAPA procedures are audit cornerstones—ours follow ICH Q10 principles

→ Data integrity is the #1 regulatory focus—our documentation SOPs are built around ALCOA+ principles

→ OOS investigations trip up even experienced labs—our procedure includes decision trees and flowcharts

Format & Customization

• Microsoft Word (.docx) format for easy customization
• Professional formatting with your company header/footer placeholders
• Bracket notation [Company Name] for quick find-and-replace
• Section numbering follows industry-standard format (1.1, 1.2, etc.)
• Regulatory references included (21 CFR, ICH guidelines)

The Bottom Line

Hiring a consultant to write 15 SOPs? $15,000–$30,000+

Diverting your QA team for 3–6 months? Priceless headaches.

This package? $497. Audit-ready by next week.

100% Satisfaction Guarantee

If these SOPs don't meet your expectations, reach out within 30 days for a full refund. No questions asked.

Questions before purchasing? Contact us at [your email]

These templates are starting points for your quality system. Each organization should review and customize procedures to match their specific operations, equipment, and regulatory requirements.