Regulatory Requirements for Laboratory Documentation

The regulatory requirements aim at the controlled handling of documentation to achieve complete traceability of information over the regulated processes. The most widely used quality management systems in laboratories of pharmaceutical, biotech, medical device, and food (USA) industries are GMP, GLP, and ISO 17025 for accredited laboratories. The latter mentioned system is not a legal requirement, but an international standard, which is inspected by commercial certifiers. 

For the batch-based quality system GMP, the following expectations of the authorities are relevant The rules for documentation of the EU GMP Chapter 4 

Requirement Good laboratory practice (GLP) Good manufacturing practice (GMP) 

Orientation Study-based QM system Batch-based QM system 

Application in USA, EU, D Nonclinical safety studies, for example, toxicology and PK studies (ADME), and analysis of body fluids from clinical trials USA Food, pharmaceuticals/drugs, medical devices, veterinary products, cosmetics EU, D Pharmaceuticals/drugs 

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