Do the GLPs require the establishment of Technical Operation Manuals?
No. 2. If a laboratory is accredited by AAALAC (American Association for Accreditation of Laboratory Animal Care), does this serve as assurance of meeting the GLP requirements for animal care and facilities? AAALAC accreditation does not substitute for Agency inspection nor does it guarantee automatic compliance with the applicable GLP sections. It is of value, however, in that it demonstrates that the facility has favorably passed a peer group review. 3. Results of the quality assurance unit inspections are not routinely available to an Agency investigator. However, the conforming amendments require that GLP deviations are to be reported in detail with each submission to the FDA. Are we required to send the contents of the quality assurance unit inspection report to the FDA? No. The GLP compliance statement in the conforming amendments to the GLPs was included for several reasons: (a) to provide an orderly transition across the effective date of the regulations. It was understood that
