An audit in life science companies is a formal review and evaluation of business practices and procedures and compliance with regulatory standards to ensure the quality and safety of products and services.
The following forms of audit are distinguished:
Internal audit, or so-called “first party audit“, is carried out by or on behalf of the organisation for internal purposes and can form the basis for its declaration of conformity.
External audit is called “second” or “third party audit“. Parties interested in the organisation (e.g., customers, authorities) or persons on their behalf carry out second-party audits. Third-party audits are carried out by external independent organisations (e.g. certifiers).
Three examples of audits in life science companies are:
- GMP audit (Good Manufacturing Practice): Verifying compliance with GMP standards in the production and quality control of pharmaceuticals, medical devices or other regulated products.
- GLP audit (Good Laboratory Practice): Assessment of compliance with GLP guidelines in research and development laboratories to ensure the integrity and reliability of non-clinical safety studies.
- GCP audit (Good Clinical Practice): Review compliance with GCP standards in clinical trials to ensure the protection of trial participants and the credibility of trial data.
