Risk management, cGMP, and the evolution of aseptic processing technology

PDA Journal of Pharmaceutical Science and Technology

Volumn 63, Issue 1, 2009, Pages 8-10

  Agalloco, James ^a   Akers, James ^b   Baseman, Hal ^c   Boeh, Richard ^d   Madsen, Russell ^e   Ostrove, Steven ^f   Pavell, Anthony ^g  

^a AGALLOCO AND ASSOCIATES   (United States)

^b Akers Kennedy and Associates   (United States)

^c Valsource   (United States)

^d NOVO NORDISK INC   (United States)

^e Williamsburg Group LLC   (United States)

^f Ostrove Associates   (United States)

^g MKCS Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLIC GMP;

ASEPSIS; ASEPTIC PROCESSING TECHNOLOGY; BIOTECHNOLOGICAL PROCEDURES; DRUG DELIVERY SYSTEM; DRUG INDUSTRY; EVOLUTION; HUMAN; INSTRUMENT STERILIZATION; MATERIALS HANDLING; MICROBIAL CONTAMINATION; NOTE; QUALITY CONTROL; RISK MANAGEMENT; SAFETY; SIMULATION; SYRINGE; TECHNOLOGY; ARTICLE; DRUG CONTAMINATION; EQUIPMENT; INJECTION; METHODOLOGY; MICROCLIMATE; PHARMACEUTICS; PRACTICE GUIDELINE; STANDARD;

ASEPSIS; CONSUMER PRODUCT SAFETY; DRUG CONTAMINATION; ENVIRONMENT, CONTROLLED; EQUIPMENT CONTAMINATION; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HUMANS; INJECTIONS; QUALITY CONTROL; RISK MANAGEMENT; SYRINGES; TECHNOLOGY, PHARMACEUTICAL;

EID: 66349085891     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (9)

1. Code of Federal Regulations, 21 CFR 210 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General, Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals, 1976.
2. International Conference on Harmonization, Q8, Pharmaceutical Development, 2006.
3. International Conference on Harmonization, ICH, Q9, Quality Risk Management, 2006.
4. International Conference on Harmonization, Q10, Pharmaceutical Quality System, 2007.
5. FDA. Draft Guidance for Industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, 2004.
6. Agalloco, J.; Gordon, B. Current practices in the use of media fills in the validation of aseptic processing. J. Parenter. Sci. Technol. 1987, 41 (4), 128-141.
7. Agalloco, J.; Akers, J. Current practices in the validation of aseptic processing - 1992. PDA Technical Report #17. J. Parenter. Sci. Technol. 1993, 47 (Supplement 1), S1-S21.
8. Agalloco, J.; Akers, J. Current practices in the validation of aseptic processing - 1996. PDA Technical Report #24. PDA J. Pharm. Sci. Technol. 1997, 51 (2), supplement.
9. Agalloco, J.; Akers, J.; Madsen, R. Current practices in the validation of aseptic processing - 2001. PDA Technical Report #36. PDA J. Pharm. Sci. Technol. 2002, 56 (3).