Why the same observations keep appearing
Good Laboratory Practice inspections in India — whether conducted by the National GLP Compliance Monitoring Authority (NGCMA) or international monitoring authorities under OECD mutual recognition — consistently reveal a predictable set of findings. These are not obscure regulatory traps. They are systemic gaps that persist because laboratories treat GLP as a documentation exercise rather than an operational culture.
After reviewing inspection reports across pharmaceutical, agrochemical, and contract research facilities, we have identified the seven most common observations — and, more importantly, the root causes that make them chronic rather than incidental.
1. Inadequate study plan amendments and deviations
The most frequent observation involves study plan amendments that are either not documented in real time, not authorised by the Study Director, or not communicated to all relevant personnel. The OECD Principles require that any deviation from the study plan be documented, justified, and acknowledged by the Study Director. In practice, Indian labs often treat amendments as administrative tasks to be completed retrospectively — which is precisely what inspectors look for.
2. Data integrity gaps (ALCOA+ non-compliance)
Data integrity remains the most scrutinised area in GLP inspections globally, and Indian laboratories are no exception. Common findings include: metadata gaps in electronic records, audit trail inconsistencies, unsigned or undated raw data entries, and the absence of documented procedures for data correction. The shift toward electronic data capture has improved traceability in some areas, but many labs operate hybrid (paper + electronic) systems that create integrity blind spots.
3. Equipment qualification and calibration deficiencies
Inspectors consistently find gaps in equipment qualification (IQ/OQ/PQ) records, missed calibration schedules, and a lack of documented impact assessments when equipment operates outside qualified parameters. The issue is compounded in laboratories with a mix of legacy and modern instruments, where qualification standards may differ across the equipment fleet.
4. Specimen and sample accountability
The chain of custody for test items, reference substances, and biological specimens is a high-priority inspection area. Findings typically involve incomplete receipt logs, inadequate storage condition monitoring, and insufficient documentation of sample disposition. In multi-site studies, transfer documentation is often the weakest link.
5. Quality Assurance independence and authority
The GLP requirement for QA independence is not merely organisational — it is operational. Inspectors frequently observe QA units that report to operations management, lack authority to halt studies when critical deviations occur, or perform inspections on a schedule that does not cover the full study lifecycle. In some cases, QA personnel lack the technical training necessary to identify substantive (not just procedural) deviations.
6. Archival integrity and retrieval
Archive management observations include: environmental monitoring gaps, incomplete indexing systems, inability to retrieve specific records within a reasonable timeframe, and physical security deficiencies. The transition to electronic archiving has introduced new challenges around format migration, long-term readability, and validated backup procedures.
7. Training documentation and competency verification
The final recurring observation concerns training records that demonstrate attendance rather than competency. Inspectors expect to see evidence that personnel not only received training, but that their competency was assessed and verified. Role-specific training (particularly for Study Directors, Test Facility Management, and QA) must demonstrate depth, not just breadth.
Prevention over remediation
Each of these observations is preventable through systematic design rather than reactive fixes. LaborWissen’s approach to GLP readiness focuses on building inspection-resilient systems — where compliance is embedded in daily operations rather than layered on top of them. Our mock inspection programme simulates the inspection experience and identifies vulnerabilities before regulators do.