PhRMA Guidelines for the Production, Packing, Repacking, or Holding of Drug Substances: Quality Control Bulk Pharmaceuticals Work Group, Quality Steering Committee, PhRMA Science and Regulatory Section

Pharmaceutical Technology

Volumn 20, Issue 1, 1996, Pages 50-63

  Lazar, Max S ^a,b  

^a HOFFMANN LA ROCHE INC   (United States)

^b PhRMA Qual Contr Bulk P ^*

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0345005843     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (2)

1. PMA QC Section, Bulk Pharmaceuticals Committee, "Concepts for the Process Validation of Bulk Pharmaceutical Chemicals," Pharm. Technol. 17 (12), 32-40 (1993).
2. 43 Federal Register 45077, 29 September 1978, as amended at 47 Federal Register 9396, 5 March 1982; 50 Federal Register 8996, 6 March 1985; 55 Federal Register 11578, 29 March 1990.