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GMP Facility Services

Pharmaceutical Quality System

A robust, independent quality unit is the foundation of every GMP operation. Zymergi provides end-to-end quality system capabilities — from batch disposition and deviation management through analytical testing and equipment qualification — so your facility stays compliant, inspection-ready, and releasing product on schedule.

  • Batch record review, product disposition, and market release
  • Deviation, CAPA, and change control management
  • Internal audits, self-inspections, and inspection readiness
  • Supplier qualification and audit programs
  • Document control — SOPs, policies, and master batch records
  • GMP training program coordination and compliance monitoring
  • GMP, FDA, EU, and ICH regulatory frameworks
  • Rigorous documentation and attention to detail
  • Root cause analysis (5-Why, Fishbone/Ishikawa)
  • Internal and external auditing
  • Risk assessment methodologies (FMEA)
  • Chemical and microbiological testing of raw materials, in-process samples, and finished products
  • Stability studies and environmental monitoring programs
  • Analytical method validation and transfer
  • Reference standard and retention sample management
  • OOS/OOT investigation and root cause determination
  • Laboratory instrument calibration and verification
  • Analytical techniques — HPLC, GC, UV-Vis, FTIR, microbial plating
  • GLP and GMP laboratory compliance
  • Data integrity principles (ALCOA+)
  • Laboratory equipment troubleshooting
  • Applied statistics for analytical data
  • IQ/OQ/PQ protocol authoring and execution for equipment, utilities, facilities, and computerized systems
  • Validation master plans, summary reports, and cleaning validation
  • Process validation (PPQ) and periodic revalidation support
  • Risk-based assessments and change impact analysis
  • GAMP 5 and CSV principles, including 21 CFR Part 11 compliance
  • Protocol and technical report writing
  • Full validation lifecycle — from URS through ongoing verification
  • Risk management tools and frameworks
  • Regulatory interpretation and technical writing

    • Get in touch — let's start with a mutual confidentiality agreement.