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3. PDA presentation at FDA Open Conference on Sterile Drug Manufacturing. Parenteral Drug Association. J Pharm Sci Technol; 1994; 48(1):4-6. PubMed ID: 8004417 [No Abstract] [Full Text] [Related]
4. Preparing for an FDA preapproval inspection. Blackmer RA Qual Assur; 1994 Dec; 3(4):389-403. PubMed ID: 7613749 [TBL] [Abstract][Full Text] [Related]
5. An FDA update on GMP's for aseptic processing. Fry EM J Parenter Sci Technol; 1985; 39(4):154-7. PubMed ID: 3928863 [No Abstract] [Full Text] [Related]
6. A review of current technology in parenteral manufacturing. Akers JE; Agalloco JP; Carleton FJ; Korczynski MS J Parenter Sci Technol; 1988; 42(2):53-6. PubMed ID: 3385542 [No Abstract] [Full Text] [Related]
7. Parenteral Drug Association response to FDA proposal to prohibit the use of any antimicrobial preservative in single-dose parenteral drug products. J Parenter Sci Technol; 1985; 39(6):231-2. PubMed ID: 4093824 [No Abstract] [Full Text] [Related]
8. Ten steps to ensure a successful preNDA approval inspection. Justice RM; Rodriguez JO; Chiasson WJ J Parenter Sci Technol; 1993; 47(2):89-92. PubMed ID: 8515350 [TBL] [Abstract][Full Text] [Related]
11. Environmental monitoring programs vs Good Laboratory Practice (GLP) programs: differences and similarities. Bentley RE Qual Assur; 1995 Dec; 4(4):283-7. PubMed ID: 8890354 [TBL] [Abstract][Full Text] [Related]
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13. Industrial hygiene in the pharmaceutical industry. Guest I; Newton D Occup Med; 1997; 12(1):81-94. PubMed ID: 9153054 [TBL] [Abstract][Full Text] [Related]
14. Getting SMART (submission management and review tracking) drug review in the computer age. Flieger K FDA Consum; 1995 Oct; 29(8):6-9. PubMed ID: 10151839 [TBL] [Abstract][Full Text] [Related]
15. Mutual recognition of pharmaceutical good manufacturing practice inspection reports, medical device quality system audit reports, and certain medical device product evaluation reports between the United States and the European Community--FDA. Final rule. Fed Regist; 1998 Nov; 63(215):60122-64. PubMed ID: 10187390 [TBL] [Abstract][Full Text] [Related]
19. Development and approval of vaccines in the United States. Botstein P Isr J Med Sci; 1986; 22(3-4):268-71. PubMed ID: 3528047 [TBL] [Abstract][Full Text] [Related]