DArcy Compliance Consulting has conducted many assessments of GLP covering experimental laboratory procedures and processes. While many Start-Up clients are in Pre IND phase, where activities may not necessarily fall under the scope of GCP or GMP, it is still important to have robustness and consistency in process. SOPs for laboratory procedures are critical not only from a regulatory perspective but also to facilitate repeatability, transparency and to demonstrate data integrity.
Take documentation for example, where there is no company wide standard for documentation, no structure for managing documents or no training on good documentation practice. In this environment documentation issues can be pervasive. In this context, the lack of integrity in the data and the inability to replicate the results can compromise great advances in the science and the progression of breakthrough therapies. This is why SOPs for GLP are important. See case study on GMP SOPs.