Can You Still Comply with GMP Without a Dedicated QA Department?

Many small and medium-sized manufacturers think Good Manufacturing Practices (GMP) are only possible if they have a fully staffed Quality Assurance (QA) department.

The truth? You can still achieve and maintain GMP compliance without a separate QA team — but only if you have the right structure, training, and systems in place.

❌ Common Challenges When There’s No Dedicated QA Department

• Lack of GMP Knowledge

  • Staff may not fully understand GMP requirements

  • GMP standards applied inconsistently across departments

• Poor Documentation Control

  • Missing or outdated SOPs

  • No centralised record-keeping system

• Weak Internal Auditing

  • Rare or informal self-inspections

  • No formal follow-up on non-conformances

• Reactive Approach to Quality

  • Problems are addressed only after they occur

  • No preventive measures or risk assessments

• Insufficient Training

  • Training done once during onboarding, then forgotten

  • No refresher sessions on GMP updates

✅ Practical Ways to Maintain GMP Compliance Without a QA Department

• Assign QA Responsibilities to Key Staff

  • Designate one or two trained employees as GMP coordinators

  • Make GMP part of their job scope and KPIs

• Implement Written SOPs

  • Ensure every process has a documented procedure

  • Regularly review and update SOPs for compliance

• Set Up a Document Control System

  • Use a central file (physical or digital) for all GMP-related documents

  • Keep version control to avoid outdated instructions

• Conduct Regular Internal Audits

  • Schedule monthly or quarterly GMP checks

  • Record findings and take corrective actions

• Use GMP Checklists for Daily Operations

  • Create checklists for cleaning, production, and storage

  • Keep them signed and dated for audit readiness

• Outsource When Needed

  • Hire external GMP consultants for annual reviews or training

  • Engage third-party labs for product testing and verification

📌 Key GMP Areas You Still Need to Cover

• Premises & Equipment: Clean, well-maintained, and pest-free environment

• Personnel Hygiene: Proper attire, handwashing, and health checks

• Process Control: Monitoring critical points in production

• Cleaning & Sanitation: Documented and validated cleaning schedules

• Traceability & Recall Procedures: Ability to track and recall products quickly

• Record Keeping: Complete and accurate documentation for all processes

⚠ Risks of Operating Without QA Oversight

• Increased chance of audit failure

• Higher risk of product contamination or recall

• Weak traceability in the event of complaints

• Potential loss of certifications (GMP, HACCP, ISO, etc.)

💡 Pro Tip: Small manufacturers without a QA department can still meet GMP standards by embedding quality responsibilities into existing roles and using structured systems for documentation, audits, and training.