Process validation: How much to do and when to do it

BioPharm

Volumn 15, Issue 10, 2002, Pages 18-28

  Rathore, Anurag S ^a   Noferi, Joseph F ^a   Arling, Edward R ^a   Sofer, Gail ^a   Watler, Peter ^a   O'Leary, Rhona ^a  

^a GG3K ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOCUMENTATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG STERILITY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; QUALITY CONTROL; REGULATORY MECHANISM; REVIEW; VALIDATION PROCESS;

EID: 0036794217     PISSN: 10408304     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. FDA, "Current Good Manufacturing Practices; Proposed Amendment of Certain Requirements for Finished Products: Supplementary Information," Federal Register 61(87), p. 20104 (3 May 1996). Available at www.fda.gov/cber/genadmin/cgmp.pdf.
2. Sofer G. and Hagel L., "Validation," Handbook of Process Chromatography: A Guide to Optimization, Scale-up, and Validation (Academic Press, New York, 1997), pp. 119-243.
3. Martin-Moe S. et al., "Validation of Critical Process Input Parameters in the Production of Protein Pharmaceutical Products: A Strategy for Validating New Processes or Revalidating Existing Processes," PDA J. Pharm. Sci. Technol. 54(4), 315-219 (July/August 2000).
4. Seely R.J. et al., "Defining Critical Variables in Well-Characterized Biotechnology Processes," BioPharm 12(4), 33-36 (April 1999).
5. Noferi J.F., Arling E.R., and Worden D.E., "Beyond QSIT," BioPharm 15(4), 40-44, 67 (April 2002).
6. Center for Drug Evaluation and Research, Guideline on the Preparation of Investigational New Drug Products (Human and Animal) (FDA, Rockville, MD, March 1991). Available at www.fda.gov/cder/guidance/old042fn.pdf.
7. European Commission, "Annex 13 Manufacture of Investigational Medicinal Products" Medicinal Products for Human and Veterinary Use: Good Manufacturing Practices, Vol. 4, Draft 1, F2/AN D(2001) (Enterprise Directorate-General, Brussels, Belgium, November 2001).
8. "General Biological Products Standards: Sterility," Code of Federal Regulations: Food and Drugs, Title 21. Part 610.12 (U.S. Printing Office, Washington, DC, revised 1 April 2001).