Quality risk management for aseptic processes

PDA Journal of Pharmaceutical Science and Technology

Volumn 62, Issue SUPPL. 1, 2008, Pages 2-38

  Ahmed, Ruhi ^a   Baseman, Harold ^b   Evans, Kristen D ^c   Ferreira, Jorge ^d   Genova, Thomas ^e   Harclerode, William ^f   Hartman, Jeffrey L ^g   Kim, Samuel ^h   Londeree, Nanette ⁱ   Long, Michael ^j   Miele, William H ^k   Ramjit, Timothy ^l   Raschiatore, Marlene ^m   Tomonto, Charles ^e  

^a BIOMARIN PHARMACEUTICAL INC   (United States)

^b ValSource LLC

^c Amgen

^d JACOBS ENGINEERING   (United States)

^e JOHNSON AND JOHNSON   (United States)

^f FOREST RESEARCH INSTITUTE   (United States)

^g MERCK RESEARCH LABORATORIES   (United States)

^h BIOGEN   (United States)

ⁱ Bayer Healthcare ^*

^j ASTRAZENECA   (United Kingdom)

^k PFIZER INC   (United States)

^l Schering Plough Corporation

^m Wyeth Pharmaceuticals

more..

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; ASEPSIS; ASEPTIC PROCESSING; AUTOCLAVE; DECISION MAKING; DRUG MANUFACTURE; DRUG PURITY; DRUG QUALITY; DRUG SAFETY; DRUG STERILITY; ENDOTOXIN DETECTION; GOOD MANUFACTURING PRACTICE; INSTRUMENT STERILIZATION; INTERPERSONAL COMMUNICATION; PROBABILITY; PROCESS CONTROL; PROCESS MODEL; PROGRAM DEVELOPMENT; QUALITY CONTROL; RISK FACTOR; RISK MANAGEMENT; RISK REDUCTION; TOTAL QUALITY MANAGEMENT;

EID: 56849099653     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. Ahmed, Ruhi; et al. PDA Survey of Quality Risk Management Practices in Pharmaceutical, Devices, & Biotechnology Industries. PDA J. Pharm. Sci. Technol. 2008, 62 (1), 1-21.
2. US Food and Drug Administration. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice; 2004.
3. International Conference on Harmonisation. Quality Guideline Q9: Quality Risk Management; 2005.
4. International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC). 51:1999 (E) Safety Aspects - Guidelines for Their Inclusion in Standards. 1999.
5. McDermott, R.E.; Mikulak, R.J.; Beauregard, M.R. The Basics of FMEA; Productivity, Inc: Portland, OR, 1995.
6. US Food and Drug Administration. Guideline on General Principles of Process Validation; 1987.
7. International Conference on Harmonisation. Quality Guideline Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances; 1999.
8. International Organization for Standardization (ISO). 14971:2000 Medical Devices - Application of Risk Management to Medical Devices, Section 2.15. 2000.
9. International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC). 60812:2006 Analysis Techniques for System Reliability Procedure for Failure Mode and Effects Analysis (FMEA). 2006.