PrimeGMP provides complete documentation solutions essential for regulatory compliance, validation, and daily GMP operations. Every document is written to be clear, audit-ready, and aligned with WHO, EU GMP, USFDA, and PIC/S expectations.

1. Cross-Contamination Control Documentation

Dedicated documentation to meet EU GMP Annex 1 & Annex 15 expectations:

• Cross-Contamination Risk Assessment
• Cross-Contamination Study Protocol & Report
• Toxicological evaluation linkage (PDE/ADE-based cleaning limits)
• Visual/chemical residue linkage to MACO limits
• Contamination Control Strategy (CCS) support

Ensures robust, science-based contamination control.

2. Risk Assessments (All Categories)

We prepare risk assessments using FMEA, HACCP, 5-Why, Fishbone, or site-specific formats:

• Equipment Risk Assessment
• Process & Manufacturing Flow Risk Assessment
• Cleaning Risk Assessment
• HVAC, Airflow & Pressure Cascade Risk Assessment
• Water System Risk Assessment
• Microbiology/Environment Risk Assessment
• Data Integrity & Computer System Risk Assessment
• Material Handling & Warehouse Risk Assessment

Risk assessments are developed to be practical, defensible, and ready for regulatory review.

3. Validation Master Plan (VMP) & Site Master File (SMF)

We prepare complete, regulator-aligned documents defining your site’s validation and GMP framework:

• Validation Master Plan (VMP)
• Site Master File (SMF)
• Validation policy, scope & lifecycle approach
• Mapping of equipment, utilities, systems, and processes
• Validation & qualification philosophy (QRM-based)

These documents provide a baseline overview for audits and regulatory inspections.

4. SOPs & Protocols

We prepare all operational and quality documents required for GMP compliance:

• Standard Operating Procedures (SOPs)
• Qualification Protocols (IQ/OQ/PQ)
• Validation Protocols (CV, PV, MV, EM, HVAC, Water, etc.)
• Study Protocols (cleaning, mapping, media fill, etc.)
• Work Instructions (WI) and Forms

Every SOP and protocol is written to be simple, operator-friendly, and regulator-approved.

5. URS, FAT, SAT, IQ/OQ/PQ, RQ Documentation

Complete lifecycle documentation for equipment, utilities, and systems:

• User Requirement Specifications (URS)
• Design Qualification (DQ)
• FAT/SAT documents
• IQ/OQ/PQ protocols & reports
• Requalification (RQ) documentation
• Change control packages

Fully aligned with GAMP 5 & Annex 15.

6. Validation & Qualification Documentation

We prepare full validation packages for:

• Cleaning Validation
• Process Validation (PPQ)
• Aseptic Process Simulation (Media Fill)
• Thermal / Temperature Mapping
• CSV & PLC/HMI
• Utilities (HVAC, PW, WFI, Steam, CA/N₂)
• Fogging & Disinfection Validation

All documents include protocols, reports, acceptance criteria & scientific justification.

7. Mock Recall & Product Traceability Documentation

• Mock recall procedures & execution reports
• Traceability matrix (RM → FG)
• Recall SOPs
• Supply chain data review

Essential for regulatory compliance & customer audits.

8. Additional QMS Documentation

We support preparation of all quality system documents:

• Deviation, CAPA, OOS & OOT templates
• Change Control forms
• Training records & matrices
• Document control formats (Master Log, Index, Revision Log)
• Audit response documentation

These strengthen your QMS and inspection readiness.