Regulatory aspects concerning the quality controls of microbiological and non-viable particulate contamination in pharmaceutical manufacturing

American Pharmaceutical Review

Volumn 7, Issue 1, 2004, Pages

  Oji, Ray T ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

SALBUTAMOL SULFATE;

ACCURACY; ANALYTIC METHOD; ARTICLE; ASEPSIS; BURKHOLDERIA CEPACIA; DRUG CONTAMINATION; DRUG ISOLATION; DRUG SAFETY; DRUG SCREENING; ENVIRONMENTAL MONITORING; ESCHERICHIA COLI; GOOD MANUFACTURING PRACTICE; HUMAN; LOWER RESPIRATORY TRACT INFECTION; MOULD; PARTICULATE MATTER; PSEUDOMONAS AERUGINOSA; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; RISK MANAGEMENT; SENSITIVITY AND SPECIFICITY; STAPHYLOCOCCUS AUREUS; VALIDATION PROCESS; YEAST;

EID: 1542725028     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. Austin, P. R., Austin Contamination Control Index: How it Works, Contamination Control, 1966.
2. Hart, A., Moore, K., and Tall, D., "A Comparison of the British Pharmacopoeia (1973) and United States Pharmacopeia (1975) Methods for Detecting Pseudomonads," Journal of Applied Bacteriology, 1976.
3. Industry Guideline on Sterile Drug Products Produced by Aseptic Processing, 1987, Food and Drug Administration.
4. PDA Technical Report No. 13, "Fundamentals of a Microbiological Environmental Monitoring Program," 1990.
5. Public Health Advisory: Contamination of Multi-dose Bottles of Albuterol Solution for Inhalation (0.5%), 2002, Food and Drug Administration.
6. United States Pharmacopeia Twenty-Sixth Revision, United States Pharmacopeial Convention, Inc., 2003.
7. Whyte, W., Cleanroom Technology - Fundamentals of Design, Testing and Operation, Wiley, Chichester, 2001.