Content development: qualification of employees - Quality Assurance - page 213

FDA (2004) Guidance for Industry: Sterile Drug
Products Produced by Aseptic Processing - Current
Good Manufacturing Practice , Rockville, MD: CDER,
September, p. 13.
FDA (2006) Managing Food Safety , College Park, MD:
Center for Food Safety and Applied Nutrition, April, p. 3.
FDA (2006) Guidance for Industry: Quality Systems
Approach to Pharmaceutical cGMP Regulations ,
Rockville, MD: CDER, September.
FDA (2008) Guidance for Industry, Process Validation:
General Principles and Practices , Rockville, MD: CDER,
November.
Ferenc, B. (1999) Qualifi cation and Change Control, in
Validation of Pharmaceutical Processes , 2nd edn,
F.J. Carleton and J.P. Agalloco (eds.), New York: Marcel
Dekker, pp. 132 and 139.
Frankos, V. (2007) Overview of the Implementation of the
Current Good Manufacturing Practices for Dietary
Supplements Guidance for Industry . College Park, MD:
Center for Food Safety and Applied Nutrition, 24 October.
International Conference on Harmonisation (ICH) (2005)
Quality Risk Management Q9 , Geneva: ICH Secretariat,
9 November, pp. 2-4.
International Organization for Standardization (2000)
Sterilization of health care products . Geneva: ISO.
Levchuk, J. (1990) Training for GMPs - A Commentary ,
presented at the Pharmaceutical Manufacturers
Association program, Training for the 90s , Arlington, VA:
September.
Levchuk, J. (1991) Training for GMPs. J. Par. Sci. Tech .
45(6), November-December, 270-5.
McDonnell, G. (2007) Antisepsis, Disinfection, and
Sterilization: Types, Actions, and Resistance , New York:
Wiley, pp. 119-22, 201-6.

￿ ￿ ￿ ￿ ￿