Analytical testing laboratories

Two American Chemical Society short courses were instrumental in the development of this manuscript. These were (1) "Quality Assurance in the Analytical Testing Laboratory/ taught by Gillis and Callio, and (2) "Good Laboratory Practices and ISO 9000 Standards Quality Standards for Chemical Laboratories," taught by Mathre and Schneider. 

Gillis, J. and Callio, S., Quality Assurance/Quality Control in the Analytical Testing Laboratory, ACS Short Course Manual, American Chemical Society, Washington, D.C., 1997. 

Table 3 PAC-ATLS Stand-Alone Analytical Testing Laboratory Site Changes... 

CDER FDA. Guidance for Industry, PAC-ATLS Postapproval Changes—Analytical Testing Laboratory Sites. U.S. Department of Health and Human Services (April 1998). 

SAMPLE HANDLING AND CONTAINMENT IN ANALYTICAL TESTING LABORATORIES... 

The written protocol should not only contain information about the batches, packages, tests, specifications, and testing schedule, but also should indicate the responsibility of the study coordinator and the analytical testing laboratories involved, if it is not already defined in SOPs. The means of data tabulation and data evaluation, including the statistical analysis to be... 

Guidance for Industry AC-ATLS Postapproval Changes—Analytical Testing Laboratory Sites... 

An analytical testing laboratory site change may be submitted as a Changes Being Effected Supplement under certain circumstances. No stability data are required. 

Food and Drug Administration (FDA) Guideline, PAC-ATLS Post Approval Changes Analytical Testing Laboratory Sites, Center for Drug Evaluation and Research (CDER), April 1998. 

FDA/CDER (April 1998) Guidance for industry post-approval changes - analytical testing laboratory sites... 

---