Cfr code of federal regulations title 21 fda home medical devices good laboratory practice for nonclinical laboratory studies 58185 reporting of nonclinical laboratory study results 58190 storage and retrieval of records and data . The food and drug administration fda is proposing to amend the regulations for good laboratory practice glp for nonclinical laboratory studies to require a complete quality system approach referred to as a glp quality system when safety and toxicity studies support or are intended to. A this part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the food and drug administration including food and color additives animal food additives human and animal drugs medical devices for human use biological products and electronic . Good laboratory practice regulations 1981 glp questions answers 3 a firm functions as a primary contractor for nonclinical laboratory studies
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