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2024 Pharmaceutical Inspections: Risk-Based, Remote-Ready, and Globally Harmonized

July 27, 2025

Staying audit-ready is no longer optional, it’s strategic! Based on EFPIA’s 2024 Inspection Survey, pharmaceutical manufacturers must align with increasingly global and risk-based inspection models. At Apotech, we help clients confidently meet these evolving expectations.

Inspection compliance is consistent: no matter the type

Whether a Pre-Approval Inspection (PAI), routine check, for-cause investigation, or surveillance audit, the criteria used by regulators remain the same.

They assess:

  • Capability
  • Adequacy
  • Suitability
  • Effectiveness

These CASE factors apply across manufacturing, equipment, control systems, and your Pharmaceutical Quality System (QMS/PQS).

Inspections can be:

  • On-site
  • Remote (real-time virtual presence)
  • Document-based

Apotech’s Inspection Readiness Services are designed to keep you compliant across all inspection formats.

Harmonization through reliance, collaboration & Risk-based approaches

The 2024 EFPIA data shows a continued move toward global cooperation among authorities. This includes:

  • Mutual Recognition Agreements (MRA)
  • Unilateral reliance on other regulatory agencies
  • Remote inspections via secured digital platforms

This reduces redundancy while upholding GMP standards—making proactive documentation and QMS alignment more critical than ever.

Document-only inspections: be ready, be structured

For paper-based inspections, the following documents are frequently requested:

  • Site Master File (SMF)
  • Annual Product Quality Review
  • Quality Manual (PQS)
  • Inspection/Audit History
  • Lists of recalls, deviations, and major changes
  • Validation documents & process flows (especially for PAI)

Standardizing these in line with PIC/S and EFPIA guidelines increases efficiency and inspection success rates. Learn more in our GMP Documentation Support services.

Inspection frequency: what to expect?

On average, 2.68 inspections occur per pharmaceutical site annually, influenced by pandemic-era adaptations and regulatory convergence through PIC/S.

This data reinforces the need for ongoing inspection readiness, not just preparation ahead of an audit, but sustained quality awareness.

Why it matters for you?

With regulatory authorities embracing digital tools, global alignment, and risk-based strategies, manufacturers need to keep pace with:

  • Remote inspection capabilities
  • Centralized documentation
  • Real-time QMS traceability

At Apotech, we offer solutions to:

  • Prepare inspection-ready document packages
  • Align QMS with current EU and PIC/S standards
  • Full inspection readiness program
  • Support remote audits and authority communications

🔗 Contact us to optimise your inspection readiness.