Biomedical Engineering Reference
In-Depth Information
of the identification of hazards and the analysis and evaluation of risks
associated with exposure to those hazards [2].
PAT : a system for designing, analyzing, and controlling manufacturing through
timely measurements (i.e., during processing) of critical quality and per-
formance attributes of raw and in-process materials and processes with the
goal of assuring final product quality [1].
REFERENCES
1. International Conference on Harmonization of Technical Requirements for Regis-
tration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline,
Pharmaceutical Development, Q8 R2, August 2009.
2. International Conference on Harmonization of Technical Requirements for Regis-
tration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline,
Quality Risk Management, Q9 Step 4, 9 November 2005.
3. International Conference on Harmonization of Technical Requirements for Registra-
tion of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Q10,
Pharmaceutical Quality System, Step 4, 4 June 2008.
4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science
and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated
Quality Systems Approach, United States Department of Health and Human
Services, U.S. Food and Drug Administration, 21 August 2002, http://www.fda
.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswerson
CurrentGoodManufacturingPracticescGMPforDrugs/ucm137175.htm.
5. PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing,
and Quality Assurance, United States Department of Health and Human Services,
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
(CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs
(ORA), Pharmaceutical CGMPs, September 2004. http://www.fda.gov/downloads
/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf.
6. European Federation of Pharmaceutical Industries and Associations (EFPIA) Mock
P2, http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=2933.
7. Sakura Tablet—Japan, http://www.nihs.go.jp/drug/section3/English%20Mock%20
QOS%20P2%20R.pdf.
8. Ace tablet, http://www.ispe.org/acetablets.pdf.
9. A-MaB Biotech,
http://www.casss.org/associations/9165/files/A-Mab_Case_Study
_Version_2-1.pdf.
10. ISPE Product Quality Lifecycle Implementation (PQLI ® ) Good Practice Guide:
Overview of Product Design, Development and Realization: A Science and Risk-
Based Approach to Implementation, http://www.ispe.org/ispepqliguides/overview
ofproductdesign.
11. PDA Paradigm Change in Manufacturing Operations (PCMO)* SM , http://www.pda
.org/pcmo/dossier.
12. European Medicines Agency PAT team, http://www.ema.europa.eu/ema/index.jsp?
curl=pages/regulation/general/process_analytical_technology.jsp&murl=menus
/regulations/regulations.jsp&mid=WC0b01ac058006e00e&jsenabled=true.
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