In addition, the pharmaceutical industry explains that studies of drug interactions must be conducted “with high quality and consistency, especially when studies end up having an impact on the design of clinical trials” (2). In addition, the U.S. FDA recommended that these studies be conducted “in the spirit of BPLs” (3), with the examiner “taking the necessary steps to ensure the quality and integrity of the data.” Good Laboratory Practice (BPL) are federal rules that require the implementation of a robust quality management system to ensure the validity, integrity and reliability of non-clinical safety data transmitted for regulatory evaluation and approval. People are often confused by good laboratory practice (BPL) rules and good manufacturing practices (GMP) because they refer to laboratory tests. This is understandable, because glops and GMPs cover laboratory tests, but are very different. In addition, scientists and quality control and quality assurance staff involved in BPL and GMP studies play different roles. GLP and GMP laboratory and manufacturing practices require significant additional investments in device maintenance and calibration, training, documentation and procedures to achieve the quality of BPL and BPL. These GLP and GMP laboratory and manufacturing practices also increase the time required to meet the complete documentation required for each of the many small steps required to meet the requirements of BPL and BPL. In addition to MarinBios level of research (non-BPL – non-GMP) work, Marin Biologic Laboratories performs scientific work under good laboratory practice (BPL) or good manufacturing practices (GMP) standards.
BPL and BPL are terms used by the FDA and regulators that define laboratory work that specifically meets rigorous laboratory research or manufacturing guidelines. MarinBio uses a quality management control system to ensure customers the consistency, consistency, reliability, reproducibility, quality and integrity of the MarinBio study. – Specific SOPs define how FDA policies are used to validate bioanalytical methods. – All methods used in BPL-compliant studies must be validated. Methods are tested for accuracy, accuracy, selectivity, sensitivity, reproducibility and stability. – Routine sample analyses are carried out with quality controls (QCs) to accept and refuse runs for BPL studies or on request. – Non-BPL studies may follow methods that have not been validated. As a general rule, the same validated methods for BPL-compliant studies are used for non-BPL studies. However, in non-BPL studies, QC is not necessarily used to accept or reject any lot.