Toward a new vision of the pharmaceutical supply chain: Full-service integrated sourcing and how it works

Pharmaceutical Technology

Volumn 22, Issue 8 SUPPL., 1998, Pages 58-66

  Cipau, Gabriel R ^a  

^a Catalytica Pharmaceuticals   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COOPERATION; DOCUMENTATION; DRUG INDUSTRY; DRUG MANUFACTURE; FINANCIAL MANAGEMENT; GOOD MANUFACTURING PRACTICE; HEALTH CARE DELIVERY; QUALITY CONTROL; RESOURCE MANAGEMENT; REVIEW; TECHNOLOGY;

EID: 0031867877     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (11)

1. 21 CFR, parts 210 and 211.
2. FDA Center for Drugs and Biologies, "Guideline for Submitting Documentation for the Stability of Human Drugs and Biologies," February 1987.
3. FDA Office of Regional Operations and CDER, "Guide to Inspection of Bulk Pharmaceutical Chemicals," September 1991, reformatted May 1994.
4. FDA Office of Regional Operations, "Guide to Inspections of High-Purity Water Systems," July 1993.
5. PMA QC Section, Bulk Pharmaceuticals Committee, "Concepts for the Process Validation of Bulk Pharmaceutical Chemicals," Pharm. Technol. 17 (12), 32-40 (1993).
6. F. Demmer et al., "FDA Regulation of Bulk Pharmaceutical Chemicals - An Industrial Commentary: Part I," Pharm. Technol. 18 (10), 80-90 (1994).
7. F. Demmer et al., "FDA Regulation of Bulk Pharmaceutical Chemicals - An Industrial Commentary: Part II," Pharm. Technol. 18 (12), 36-43 (1994).
8. Quality Control Bulk Pharmaceuticals Work Group, Quality Steering Committee, PhRMA Science and Regulatory Section, "PhRMA Guidelines for the Production, Packing, Repacking, or Holding of Drug Substances: Part I," Pharm. Technol. 19 (12), 22-32 (1995).
9. Quality Control Bulk Pharmaceuticals Work Group, Quality Steering Committee, PhRMA Science and Regulatory Section, "PhRMA Guidelines for the Production, Packing, Repacking, or Holding of Drug Substances: Part II," Pharm. Technol 20 (1), 50-63 (1996).
10. European Federation of Pharmaceutical Industries Association and European Chemical Industry Council, "EFPIA/CEFIC Final Draft: Good Manufacturing Practices for Active Ingredient Manufacturers," December 1995.
11. International Conference on Harmonization, "Stability Testing of New Drug Substances and Products," Federal Register 59, 48754 (22 September, 1994).