GMP Audit
A GMP audit (GoodManufacturing Practice audit) is an essential part of quality assurance in regulated industries such as pharmaceuticals, biotechnology, food and laboratories. These audits are used to verify whether a company complies with GMP standards and can consistently produce safe, high-quality products.
Audits may be conducted by internal QA teams, external clients or regulatory authorities like the MHRA, FDA or EMA. Regardless of who performs the audit, the expectations are clear: you must demonstrate documented control over your processes.
What do GMP auditors look for?
A successful GMPaudit is built on transparency, consistency and documented evidence. Inspectorstypically review:
- Standard Operating Procedures (SOPs) – Are they clearly written, version-controlled and followed in practice?
- Deviations and CAPAs – Are issues logged, investigated and resolved in a structured, documented way?
- Audit trails – Can the company show who did what, when, under which conditions, without any data gaps?
- Training and responsibility – Are personnel properly trained and is access to systems role-based?
Auditors also expect real-time access to records, not just historical data, but also current monitoring (e.g. of temperature, humidity, cleanroom conditions). Incomplete or inconsistent records are common causes of audit observations or warnings.
The role of digital systems in audit readiness
Digital systems can significantly improve GMP compliance by reducing manual errors, guaranteeing version control and providing secure and traceable data. These systems should be validated, include electronic signatures and offer full audit trails that are inspection-ready at any time.
Understanding what GMP audits require is the first step toward building a system, digital or otherwise, that supports long-term compliance and continuous improvement.