14.
REFERENCES
1.
Interum Guidance to the Pharmaceutical Industry for Environmental
Assessment Compliance Requirements for the FDA. Vol 7, Pharmaceutical
Manufacturers Association, 1991.
2. “Technical Assistant Document (TAD)”, FDA Environmental Assessment Technical Assistance Handbook, NTIS PB87-175345.
3.
Handbook of Chemical Property Estimation Methods, W.J. Lyman, W.F. and D.H. Rosenblatt,
American Chemical Society; Washington D.C., 1990
4.
FDA NEPA Strategy Perspective, P.G. Vincent Ph.D., Invitational Paper
Presentation, American Institute of Chemical Engineers, Pittsburgh, PA, August
18-21, 1991
5.
U.S.
Environmental Protection Agency, CFR Part 40 § 122, The National Pollutant
Discharge Elimination System (NPDES).
6.
U.S.
Environmental Protection Agency, CFR 40 § 403, EPA Standards.
7.
U.S.
Environmental Protection Agency, CFR Part 40 § 439, Guidelines and Standards
for Pharmaceutical Manufacturing.
8.
U.S.
Environmental Protection Agency, CFR Part 40 40 § 60, EPA Regulations on
Standards and Performance for New Stationary Sources
9.
U.S.
Environmental Protection Agency, CFR Part 40 40 § 260-280 – Hazardous Waste
Management System.
10.
Federal
Water Pollution Control Act, PL 92-500.
11.
Clean
Air PL 90-128.
12.
Clean
Water Act PL 95-217, as amended.
13.
Resources
Conservation and Recovery Act (RCRA) PL 91-580 of 1976, as amended.
14.
Environmental
Protection Act, Parts I & II, United Kingdom
15.
Water
Resources Act, United Kingdom, 1991
16.
Water
Industry Act, United Kingdom, 1991
17.
The Merck Index, 11th Edition, Merck & Co., Inc., Rahway, NJ, 1989, p 228.
18. Physical Pharmacy, A. Martin, J. Swarbrick, and A. Cammarata, Lea & Febiger, Philadelphia, PA, 1983, pp. 391-4
GCPV/93/0011/03 22
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