Drugs and related topics.
Drugs is a topic that was certainly an issue of discussion at this year's annual meeting. This Committee had the responsibility of organizing a half day symposium on "Pharmaceutical Authenticity and Safety" that took place September 12, 2005. This symposium aims at improving the critical points in the analytical pharmaceutical field related to traceability assessment, use of certified reference materials (CRMs), and proficiency testing implementation to get the highest quality of the obtained results. Recognized experts presented these topics. Also, other complementary subjects, such as the application of advanced analytical technologies to reach the authenticity and safety of the pharmaceutical drugs and drug products, their microbiological quality assessment, without disregarding an important topic such as sampling, was presented and discussed. The talks that were presented are the following: "Proficiency Testing as a Need in the Pharmaceutical Field," Arlene Fox (AOAC INTERNATIONAL, Gaithersburg, MD); "Implementation of Traceability in the Pharmaceutical Laboratory," Thomas Layloff, (Management Sciences for Health, Arlington, VA); "Harmonized Characteristics of Certified Reference Materials According to ISO Guides-Attractive also for Pharmaceutical Analysis," Hendrik Emons (Reference Materials, Unit Institute for Reference Materials and Measurements (IRMM), Joint Research Centre European Commission, (Geel, Belgium); "Importance of LC/MS/MS for the Fingerprinting of Pharmaceutical Drugs," Paul A. Steinberg, (Thermo Electron Corp., Woodstock, GA); "Process Analytical Technology (PAT) as a Way for Better Manufacturing and Quality Assurance," John F. Kauffman (Division of Pharmaceutical Analysis, U.S. Food and Drug Administration (St. Louis, MO); "Stability Testing for the Safety Assessment of Pharmaceuticals," Marta Vidal (Boeringher Ingelheim Argentina, Buenos Aires, Argentina); "Validation of Microbiological Methods for Sterile and Nonsterile Pharmaceutical Products," Michael Brodsky (Brodsky Consultants, Thornhill, ON, Canada); "The Relationship Between Pharmacopoeial Reference Standards and ISO REMCO Initiatives and Guides," Ronald G. Manning (United States Pharmacopoeia, Rockville, MD).
Cereijo
Ines
I
Justesa Imagen Argentina S.A., Viamonte 1328, 9(o) piso, Buenos Aires, Argentina. icereijo@ciudad.com.ar
D002138:Calibration; D002623:Chemistry Techniques, Analytical / Q000295:instrumentation / Q000379:methods*; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D004345:Drug Industry; D004355:Drug Stability; D004364:Pharmaceutical Preparations / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical
D004364:Pharmaceutical Preparations