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1

PDA response. FDA proposal to amend cGMP's entitled--use of aseptic processing and terminal sterilization in the preparation of sterile pharmaceuticals for human and veterinary use. Parenteral Drug Association.

[No authors listed] [No authors listed] J Parenter Sci Technol. 1992 May-Jun;46(3):65-8. J Parenter Sci Technol. 1992. PMID: 1522442 No abstract available.

2

An FDA update on GMP's for aseptic processing.

Fry EM. Fry EM. J Parenter Sci Technol. 1985 Jul-Aug;39(4):154-7. J Parenter Sci Technol. 1985. PMID: 3928863 No abstract available.

3

PDA presentation at FDA Open Conference on Sterile Drug Manufacturing. Parenteral Drug Association.

[No authors listed] [No authors listed] J Pharm Sci Technol. 1994 Jan-Feb;48(1):4-6. J Pharm Sci Technol. 1994. PMID: 8004417 No abstract available.

4

Draft guidance for industry; container and closure integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products; availability--FDA. Notice.

[No authors listed] [No authors listed] Fed Regist. 1998 Jan 28;63(18):4272-3. Fed Regist. 1998. PMID: 10177326

5

Parenteral Drug Association response to FDA proposal to prohibit the use of any antimicrobial preservative in single-dose parenteral drug products.

[No authors listed] [No authors listed] J Parenter Sci Technol. 1985 Nov-Dec;39(6):231-2. J Parenter Sci Technol. 1985. PMID: 4093824 No abstract available.

6

Parenteral Drug Association response to the FDA compliance policy guide, #7132a.13, entitled, "Parametric release--terminally heat sterilized drug products".

[No authors listed] [No authors listed] J Parenter Sci Technol. 1988 Jul-Aug;42(4):105. J Parenter Sci Technol. 1988. PMID: 3183862 No abstract available.

7

Foreign establishment registration and listing. Final rule.

Food and Drug Administration, HHS. Food and Drug Administration, HHS. Fed Regist. 2001 Nov 27;66(228):59138-61. Fed Regist. 2001. PMID: 11776289 Free article.

8

FDA's aseptic processing: proposed regulation.

Barr DB. Barr DB. J Parenter Sci Technol. 1993 Mar-Apr;47(2):57-9. J Parenter Sci Technol. 1993. PMID: 8515345 No abstract available.

9

Helpful tips for extralabel drug use: record keeping, record access, and product labels. The FDA-Center for Veterinary Medicine and the American Veterinary Medicine Association.

[No authors listed] [No authors listed] J Am Vet Med Assoc. 1998 Mar 1;212(5):666-7. J Am Vet Med Assoc. 1998. PMID: 9556375 No abstract available.

10

PDA's response to FDA's "Guideline on sterile drug products produced by aseptic processing".

Akers JE, Agalloco JP, Carleton FJ, Korczynski MS. Akers JE, et al. J Parenter Sci Technol. 1988 Jul-Aug;42(4):114-7. J Parenter Sci Technol. 1988. PMID: 3183865 No abstract available.

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