Cleaning validation in a pharmaceutical research facility

Pharmaceutical Technology

Volumn 22, Issue 9, 1998, Pages 104-112

  Forsyth, Richard J ^a   Haynes, Dorothy V ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLEANING; DRUG INDUSTRY; PRACTICE GUIDELINE; RESIDUE ANALYSIS; STANDARD;

EID: 0031702789     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. FDA, "Guide to Inspection of Validation of Cleaning Processes" (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, July 1993).
2. "GMP Trends," citations surveyed from 1987-1992 (GMP Trends, Inc., Boulder, CO).
3. PMA, Cleaning Validation Survey (Oct. 1992).
4. K.M. Jenkins and A.J. Vanderwielen, "Cleaning Validation: An Overall Perspective," Pharm. Technol. 18 (4), 60-73 (1994).
5. H.L. Avallone, "Manufacture of Clinical Products," Pharm. Technol. 14 (9), 150-158 (1990).
6. G.L. Fourman and M.V. Mullen, "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations," Pharm. Technol. 17 (4), 54-60 (1993).
7. D.L. Conine, B.D. Naumann, and L.H. Hecker, "Setting Health-Based Residue Limits for Contaminants in Pharmaceuticals and Medical Devices," Qual. Assur: Good Prac., Regul. & Law 1, 171-180 (1992).