Crobiological quality of drug products after penetration of the container system for dose preparation prior to patient administration: Microbiology

American Pharmaceutical Review

Volumn 12, Issue 1, 2009, Pages

  Metcalfe, John W ^a  

^a UNIVERSITY OF RHODE ISLAND   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG PRESERVATIVE; GLUCOSE; SODIUM CHLORIDE;

ASEPSIS; DRUG ADMINISTRATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG QUALITY; DRUG STABILITY; DRUG STORAGE; DRUG SYNTHESIS; HUMAN; INFUSION; MICROBIAL GROWTH; MICROBIAL IDENTIFICATION; MICROBIOLOGY; RISK ASSESSMENT; SHORT SURVEY;

EID: 62549088296     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (7)

1. Guidance for Industry, Q1A (R2) Stability Testing of New Drug Substances and Products. ICH. November 2003.
2. Guidance for Industry, Q8 Pharmaceutical Development. ICH. May 2006.
3. Guidance for Industry, Q9 Quality Risk Management. ICH. June 2006.
4. Mattner, F. & P. Gastmeier. 2004. Bacterial Contamination of Multiple-Dose Vials: A Prevalence Study. Assoc. for Professionals in Infection Control and Epidemiology. 32: 12-16.
5. Nichols, RL. & J.W. Smith. 1995. Bacterial Contamination of an Anesthetic Agent. New England Journal of Medicine. 333: 184-185.
6. Nogler-Semenitz. et. al. 2007. Bacterial Contamination of Solutions for Parenteral Administration for Single-and Multiple-dose Vials after Multiple Use in the Hospital. Wien med Wochesnschr. 157: 398-401.
7. USP 31/NF 26. United States Pharmacopeial Convention. 2008.