Validation and commissioning

Pharmaceutical Engineering

Volumn 18, Issue 1, 1998, Pages 40-44

  Angelucci III, Louis A ^a,b  

^a Foster Wheeler Ltd   (United States)

^b ISPE ^*

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INDUSTRY; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; PHARMACEUTICAL ENGINEERING; REVIEW; VALIDATION PROCESS;

EID: 0031883351     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. Department of Health and Human Services, Guidelines on General Principles of Process Validation, 1987.
2. Wesley P. Wheeler, "Commissioning: A Vital Precursor to Validation," Pharmaceutical Engineering, 4 (July/August 1994), p. 48.
3. Department of Health and Human Services, Food and Drug Administration, 21 CFR Parts 210 and 211.
4. Daniel J. Tisak and Robert E. Koster, "Validation Commissioning Documents: A Checklist Approach for Facility Validation," Journal of Validation Technology, Vol. 3, Number 4 (August 1997), pp. 394-397.
5. ISPE and FDA, Pharmaceutical Engineering Guides for New Facilities, Vol. 1, Bulk Pharmaceutical Chemicals, First Edition (June 1996).
6. Merriam Webster's Collegiate Dictionary, Merriam-Webster, Incorporated, Springfield, Massachusetts, Tenth Edition, copyright 1997, p. 231.