Fdas glp regulations, nonclinical laboratories will still. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Good clinical laboratory practice standards final version 3. This is the second version of the who handbook on glp. The comments noted that unless epa amends its good laboratory practice standards to conform them to. Fda employees may access the current controlled version of the cfsan laboratory quality manual through the cfsan intranet website under laboratory quality assurance program. Both original and amended versions of reports from all contributing. Tdr developed a good laboratory practices glp series in 2001.
The qa sop manual should describe qau audit and in spection techniques. This third edition of good laboratory practice regula. This guidance document is provided to clearly define the standards that encompass gclp to include applicable portions of 21 code of federal regulations cfr part 58, or glp, and 42 cfr part 493, or clinical laboratory improvement amendment clia rules. Good laboratory practice for nonclinical laboratory studies 21 cfr part 58 investigational new drug application 21 cfr part 312 applications for fda approval to market a new drug 21 cfr part 314. Good laboratory practice for nonclinical laboratory studies. Tdr developed a good laboratory practices glp series in 2001, comprising a glp handbook as well as. Environmental protection agency epa discussion forum. Regulatory and safety evaluation specialty section webinar september 29, 2017 mark seaton, ph. List of fda inspections of facilities that perform nonclinical laboratory studies. No audit trail is kept for changes to temporary file. It is the result of experience gained since the first version was published. Good laboratory practice for nonclinical laboratory studies docket.
Good laboratory practice regulations management briefings. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888info fda 18884636332 contact fda. Good laboratory practice for nonclinical laboratory studies fda. Daids has developed, in collaboration with ppd, the attached daids guidelines for good clinical laboratory practice gclp standards.
The fda483 is the written notice of objectionable practices or deviations. Comparison chart of fda and epa good laboratory practice. Daids guidelines for good clinical laboratory practice. An update on fdas good laboratory practice glp for nonclinical. The good laboratory practices glps are extremely effec tive guidelines. The principles of good laboratory practice of the organisation for economic cooperation and development oecd form the basis of this series of guidance documents. The mission of the division of aids daids of the national institute of allergy and infectious diseases niaid, national institutes of health nih is to help ensure an end. Good laboratory practice for nonclinical laboratory. Fda2010n0548 for good laboratory practice for nonclinical. An update on fdas good laboratory practice glp for nonclinical laboratory studies proposed rule sot.
The information on this page is current as of april 1 2019. Daids guidelines for good clinical laboratory practice standards effective date. Do the glps apply to validation trials conducted to confirm the analytical. Cfr code of federal regulations title 21 food and drug. Guidance for industry, good laboratory practice regulations management briefings.