200
BIBLIOGRAFIA
Agalloco J., Akers J., Madsen R. (2004). Aseptic Processing: A Review of Current Industry Practice. Pharmaceutical Technology, 28(10):126–50
Al-Khaldi S.F., Mossoba M.M. (2004). Gene and Bacterial Identification Using High-Throughput Technologies: Genomics, Proteomics, and Phonemics. Nutrition Volume 20, Numero 1
Balboni M.L. (2003). Process Analytical Technology – Concepts and Principles. Pharmaceutical Technology
Bartholomew J.W., Mittwer T. (1952). The Gram stain Bacteriol Review, 16(1): 1–29
Beaney A.M. (2006). Quality assurance of aseptic preparation services Pharmacetical Press
Ceschel G.C.,(1982). Impianti per l’industria farmaceutica. Società Editrice Esculapio
Clark R.P., Cox R.N. (1973). The generation of aerosols from the human body Airborne transmission and airborne infection, pp. 413-426
Clifton J., Kerby F. (1983). Source, Significance, and Control of Indoor Microbial Aerosols: Human Health Aspects. Public Health Reports, Vol. 98, No. 3
Cox C., Wathes C (1995). Bioarosols handbook – Chapter 11: Modern microscopic methods of Bioaerosol analysis. CRC Press
Department of Defense USA (1980). Military standard: Procedure for performing a failure mode, effects and critical analysis
Direttiva 2001/83/CE del Parlamento europeo e del Consiglio del 6 novembre 2001 recante un codice comunitario relativo ai medicinali per uso umano
201
Direttiva 2003/94/CE della commissione dell'8 ottobre 2003 che stabilisce i principi e le linee direttrici delle buone prassi di fabbricazione relative ai medicinali per uso umano e ai medicinali per uso umano in fase di sperimentazione
Dlgs n.219 – “Attuazione della direttiva 2001/83/CE (e successive direttive di modifica) relativa ad un codice comunitario concernente i medicinali per uso umano, nonché della direttiva 2003/94/CE” – Gazzetta Ufficiale n. 142, Supplemento Ordinario n. 153, 21 giugno 2006
D.P.R. n.392 – “Regolamento recante norme per la semplificazione dei procedimenti di autorizzazione alla produzione ed all’immissione in commercio di presidi medico-chirurgici, a norma dell’articolo 20, comma 8, della L. 15 marzo 1997, n.59” – Gazzetta Ufficiale n. 266, 13 novembre 1998
EU GMP (2008). Annex 1: Manufacture of Sterile Medicinal Products
EU GMP (2010). Annex 11: Computerised Systems
EU GMP (2001). Annex 15: Qualification and validation
EU GMP (2008). Annex 20 Tools and Potential Application
EU GMP (2005). Volume IV: GMP Human & Veterinary
European Pharmacopeia 7.0 (2011). Chapter 5.20 Parenteral preparations
European Pharmacopeia 7.0 (2011). Chapter 5.1.1. Methods of preparation of sterile products
Favero M.S., Puleo J.R., Marshall J.H., Oxborrow G.S. (1996). Comparative Levels and Types of Microbial Contamination Detected in Industrial Clean Rooms. Applied Microbiology, vol. 14, no. 4
202
FDA (1997). 21 CFR Part 11: Electronic Records; Electronic signature; Final Rule. Federal Register, Vol. 62, No. 54
FDA (2002). Guidance for Industry: Pharmaceutical cGMPs for the 21st century: a risk-based approach
FDA (2003). Guidance for Industry: Part 11, Electronic Records; Electronic signature – Scope and Application
FDA (2004). Guidance for Industry: Sterile drug products produced by Aseptic Processing – Current good manufacturing practice
FDA (2004). Guidance for Industry: PAT – A framework for innovative pharmaceutical development, manufacturing and quality assurance
Friedman M. (1937). The Use of Ranks to Avoid the Assumption of Normality Implicit in the Analysis of Variance. Journal of the American Statistical Association, Vol. 32, No. 200, pp. 675-701
Friedman R.L. (2005). Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System. PDA Journal of Pharmaceutical Science and Technology, Vol. 59, No. 2
Fung, D.Y.C. (2002). Rapid Methods and Automation in Microbiology. Comprehensive reviews in food science and food safety, Vol. 1
Jennison, M.W. (1941). Atomization of mouth and nose secretions into the air as revealed by high-speed photography. Aerobiology 17:106-128
Jimenez L. (2004). Microbial contamination control in the pharmaceutical industry - Chapter 1: Microorganisms in the Environment and Their Relevance to Pharmaceutical Processes. Informa Healthcare
203
Jimenez L. (2004). Microbial contamination control in the pharmaceutical industry - Chapter 2: Microbial Limits. Informa Healthcare
Jimenez L. (2004). Microbial contamination control in the pharmaceutical industry - Chapter 5: Environmental Monitoring. Informa Healthcare
Jimenez L. (2004). Microbial contamination control in the pharmaceutical industry - Chapter 7: Rapid Methods for Pharmaceutical Analysis. Informa Healthcare
Jimenez L. (2007). Microbial diversity in pharmaceutical product recalls and environments. PDA Journal of Pharmaceutical Science and Technology, 61(5):383-99
Kramer A., Schwebke I., Kampf G. (2006). How long do nosocomial pathogens persist on inanimate surface? A systematic review. BMC Infectious Diseases 6:130
Kummer V., Thiel W. R. (2008). Bioaerosols – Sources and control measures. Inter. J. Hyg. Environ.-Health, Vol. 211, p.299-307
GAMP 5 (2008). Good Automated Manufacturing Practices – A Risk Based Approach to Compliant GxP Computerized System. International Society for Pharmaceutical Engineering
Hussong D. (2004). Analysis of environmental microbiology data from cleanroom samples. Pharmaceutical Technology Aseptic Processing
ICH Q8 (2009). Pharmaceutical Development
ICH Q9 (2005). Quality Risk Management
ICH Q10 (2008). Pharmaceutical Quality System
ISO 14644-1:1999. Cleanrooms and associated controlled environments – Parte 1: Classification of air cleanliness
204
ISO 14698-2:1999. Cleanrooms and associated controlled environments - Biocontamination control – Parte 2: Evaluation and interpretation of biocontamination data
Miller J.M., Rhoden D. (1971). Preliminary evaluation of Biolog, a carbon source utilization method for bacterial identification. Journal of clinical microbiology, Volume 29, Numero 6, p. 1143-1147
Moldenhauer J. (2005). Volume 1: Environmental monitoring: a comprehensive handbook. PDA/DHI
Moldenhauer J. (2005). Volume 2: Environmental monitoring: a comprehensive handbook. PDA/DHI
Montanaro L., Arciola C. (2000). Chapter 21: “Studying bacterial adhesion to irregular or porous surface. Handbook of Bacterial Adhesion, Humana Press
Oldenhof M.T., Van Leeuwen J.F., Nuta M.J., De Kaste D., Odekerken-Rombouts Y.M.C.F., Vredenbregt M.J., Weda M., Barends D.M. (2010). Consistency of FMEA used in validation of analytical procedures. Journal of Pharmaceutical and Biomedical Analysis, Volume 54, p.592-595
Parker M.T. (1971). The clinical significance of the presence of micro-organisms in pharmaceutical and cosmetic preparations. Journal of the society of cosmetic chemists, Volume 23, p.415-426
PDA (2001). Technical report No.13 revised: Fundamentals of an Environmental Monitoring Program
Rathore A.S., Winkle H. (2009). Quality by design for biopharmaceuticals. Nature Biotechnology, Volume 27, Number 1
205
Scott B, Wilcock A.(2006). Process analytical technology in the pharmaceutical industry: a toolkit for continuous improvement. PDA Journal of Pharmaceutical Science and Technology, Vol. 60, No. 1 17-53
Senders J.W. (2004). FMEA and RCA: the mantras of modern risk management. Qual. Saf. Health. Care., 13(4):249-50
Sinclair C.S., Tallentire A. (1995). Performance of blow/fill/seal equipment under controlled airborne microbial challenges. PDA Journal of Pharmaceutical Science and Technology, 49 (6), 294-299
Sheraba et al. (2010). High-throughput molecular identification of Staphylococcus spp. isolated from a clean room facility in an environmental monitoring program. BMC Research Notes, 3:278
Smart R., Spooner D. F. (1972). Microbiological spoilage in pharmaceuticals and cosmetics, Journal of the society of cosmetic chemists. Volume 23, p.721-737
Srikanth P., Sudharsanam S., Steinberg R. (2008). Bio-aerosols in indoor environment: Composition, health effects and analysis. Indian J. Med. Microbiol., 26(4):302-12.
Stetzenbach L.D., Buttner M.P., Cruz P. (2004). Detection and enumeration of airborne biocontaminats. Curr. Opin. Biotechnol., 15(3):170-4
Sutton S. (2011). Successful microbiological investigation. American Pharmaceutical Review, Volume 14
S. Scott (2010). The environmental monitoring program in a GMP environment. Journal of Gxp Compliance, Volume 14
Thornton E., Brook O.R., Mendiratta-Lala M., Hallett D.T., Kruskal J.B. (2011). Application of Failure Mode and Effect Analysis in a Radiology Department. Radiographics, 31(1):281-93
206
Tracy D.S., Nash R.A. (2009). A Validation Approach for Laboratory Information Management Systems. Journal of Validation Technology, Volume 9, Number 1
UNI EN 1822-1 (2010). Filtri per l’aria ad alta efficienza (EPA, HEPA e ULPA) – Parte 1: Classificazione, prove di prestazione, marcatura
USP <1010> (2009). Analytical Data- Interpretation and Treatment
Van Leeuwen J.F., Nuta M.J., De Kaste D., Odekerken-Rombouts Y.M.C.F., Oldenhof M.T., Vredenbregt M.J., Barends D.M. (2009). Risk analysis by FMEA as an element of analytical validation. Journal of Pharmaceutical and Biomedical Analysis, p.1085-1087
World Health Organization (2006). Quality Assurance of Pharmaceutical. Volume 2
Wu et al. (2007). Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit. J Zhejiang Univ Sci B 8(9):666-672
Zimmermann H.F., Hentschel N. (2011). Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool. PDA Journal of Pharmaceutical Science and Technology, 1;65(5):506-12.