Enterprise GxP SOP Package

The complete quality management system for pharmaceutical and biotech organizations

You need more than templates. You need a compliance infrastructure.

Building a comprehensive GxP quality system isn't just time-consuming—it's a strategic risk. Every month without proper documentation is another month of exposure during audits, client assessments, and regulatory inspections.

This package delivers 25+ professionally-written Standard Operating Procedures that form the backbone of a complete pharmaceutical quality management system. Developed by a Quality Control Supervisor with 10+ years of hands-on GLP/GMP experience at leading CROs and biotechs—including specialized expertise in bioanalytical operations, antibody drug conjugates, and large molecule therapeutics.

What's Included

25+ Comprehensive SOPs

Quality System Foundation

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

Manufacturing & Laboratory Operations

• Batch Record Review
• Laboratory Notebook & Data Recording
• Sample Management & Chain of Custody
• Method Validation/Verification
• Out-of-Specification (OOS) Investigations
• Stability Studies
• Environmental Monitoring
• Supplier/Vendor Qualification
• Cleaning Validation
• Process Validation

Data Integrity & Compliance

• Computer System Validation (CSV)
• Electronic Records & Signatures (21 CFR Part 11)
• Data Integrity Policy
• Risk Management

Specialized & Advanced

• Product Complaint Handling
• Recall Procedures
• Technology Transfer
• Annual Product Review (APR)
• Regulatory Agency Inspection Readiness
• Contract Laboratory/CMO Oversight
• Reference Standard Management

Enterprise-Exclusive Features

✓ Custom Branding

Every SOP delivered with your company logo, header, and document numbering system pre-configured. No reformatting required—just review and implement.

✓ Phone Support

Direct phone access to discuss implementation strategy, regulatory questions, and customization guidance. Not a chatbot. Not a ticket queue. A real conversation with someone who's been through FDA inspections.

✓ Weekly Updates

Regulations evolve. So do your SOPs. Receive updated versions as guidance documents change, new FDA expectations emerge, or industry best practices shift.

✓ On-Site Training Option

Optional add-on for organizations that want hands-on implementation support. Train your team on the procedures, walk through your specific workflows, and ensure everyone understands not just the "what" but the "why."

Who This Is For

• Mid-size pharmaceutical companies building or upgrading their quality systems
• Contract Research Organizations (CROs) serving multiple clients with varying requirements
• Contract Manufacturing Organizations (CMOs) needing comprehensive production documentation
• Biotech companies preparing for Phase III trials or commercial manufacturing
• Organizations facing FDA inspection who need to close documentation gaps quickly
• Quality leaders inheriting a broken system and needing to rebuild fast

Why 25+ SOPs?

Because regulators don't audit one procedure at a time. They audit systems.

When an FDA investigator walks through your facility, they're looking for interconnected documentation that demonstrates control. Your training SOP should reference your document control SOP. Your deviation procedure should connect to your CAPA process. Your batch record review should tie into your OOS investigations.

This package is designed as a system—with cross-references built in, consistent formatting throughout, and logical connections between procedures. It's not 25 separate documents. It's one cohesive quality infrastructure.

The Regulatory Foundation

Every SOP is built on current regulatory requirements:

→ 21 CFR Parts 210/211 – Current Good Manufacturing Practice

→ 21 CFR Part 11 – Electronic Records and Signatures

→ 21 CFR Part 58 – Good Laboratory Practice

→ ICH Q7 – GMP for Active Pharmaceutical Ingredients

→ ICH Q9 – Quality Risk Management

→ ICH Q10 – Pharmaceutical Quality System

→ EU GMP Annex 15 – Qualification and Validation

→ ALCOA+ Principles – Data Integrity Framework

Format & Deliverables

• Microsoft Word (.docx) – Fully editable and customizable
• Professional formatting – Consistent headers, hierarchical numbering (1.1, 1.1.1), and clean typography
• Bracket notation – [Company Name], [SOP-XXX] placeholders for quick customization
• Form templates included – Checklists, logs, and forms referenced in each SOP
• Cross-reference index – Map showing how all 25+ SOPs connect

The Math

Consultant rates for SOP development: $150–300/hour

Time to develop 25+ SOPs from scratch: 400–600 hours

Typical consulting engagement: $60,000–$180,000

Your team's time diverted from operations: Immeasurable

This package: $997

Time to implementation: Days, not months

Guarantee

If this package doesn't provide the foundation you need for your quality system, contact us within 30 days for a full refund. We're confident in the quality because we've used these same frameworks to pass FDA inspections, satisfy client audits, and build compliant operations from the ground up.

Frequently Asked Questions

Can I modify these SOPs for my specific processes? Absolutely. That's the intention. These are comprehensive templates designed to be customized with your equipment, personnel titles, and specific workflows.

Do these work for both GLP and GMP environments? Yes. The package includes procedures applicable to both laboratory (GLP) and manufacturing (GMP) environments, with clear notation where requirements differ.

What format are the files? Microsoft Word (.docx) for full editability. All formatting, styles, and numbering are preserved.

How is custom branding handled? After purchase, send us your logo and preferred document header format. We'll configure all 25+ documents with your branding before delivery.

What's included in phone support? Up to 3 hours of phone consultation within 90 days of purchase. Use it for implementation questions, regulatory interpretation, or customization guidance.

Questions before purchasing? Contact us at [your email]

These templates provide a comprehensive foundation for your quality management system. Each organization should review and customize procedures to align with their specific operations, products, and regulatory jurisdiction.