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1.
Sterile product pre-approval/post-approval inspections.
Avallone, H L.
PDA J Pharm Sci Technol ; 48(4): 211-6, 1994.
Article in English | MEDLINE | ID: mdl-7804821

Subject(s)
Dosage Forms/standards , Drug Approval , Sterilization/standards , Environment, Controlled , Facility Design and Construction , Guidelines as Topic , Quality Control , Reproducibility of Results
2.
Food and Drug Administration inspection and licensing of manufacturing facilities.
Avallone, H L; Beatrice, M G; Sze, T T.
Bioprocess Technol ; 13: 315-40, 1991.
Article in English | MEDLINE | ID: mdl-1367137

Subject(s)
Drug Industry/legislation & jurisprudence , Facility Regulation and Control , Licensure , United States Food and Drug Administration , Drug Industry/standards , United States
3.
Aseptic processing of non-preserved parenterals.
Avallone, H L.
J Parenter Sci Technol ; 43(3): 113, 1989.
Article in English | MEDLINE | ID: mdl-2732849

Subject(s)
Antisepsis/methods , Asepsis/methods , Drug Contamination/prevention & control , Solutions/standards , Infusions, Parenteral
4.
Laboratory controls--an FDA investigator's viewpoint.
Avallone, H L.
J Parenter Sci Technol ; 40(5): 178-82, 1986.
Article in English | MEDLINE | ID: mdl-3794896

Subject(s)
Drug Industry/standards , Laboratories/standards , Quality Control , United States , United States Food and Drug Administration
5.
Regulatory aspects of lyophilization.
Avallone, H L; Wolk, A E.
J Parenter Sci Technol ; 40(3): 81-2, 1986.
Article in English | MEDLINE | ID: mdl-3746576

Subject(s)
Freeze Drying , Technology, Pharmaceutical/standards , Sterilization
6.
Sterility retesting.
Avallone, H L.
J Parenter Sci Technol ; 40(2): 56-7, 1986.
Article in English | MEDLINE | ID: mdl-3723250

Subject(s)
Sterilization , Quality Control
7.
Control aspects of aseptically produced products.
Avallone, H L.
J Parenter Sci Technol ; 39(2): 75-9, 1985.
Article in English | MEDLINE | ID: mdl-3989616

Subject(s)
Antisepsis/standards , Asepsis/standards , Drug Contamination/prevention & control , Drug Industry/standards
8.
Inspectional guidelines for sterile bulk antibiotics.
Avallone, H L.
J Parenter Drug Assoc ; 34(6): 447-51, 1980.
Article in English | MEDLINE | ID: mdl-6906367

Subject(s)
Anti-Bacterial Agents/standards , Asepsis , Drug Compounding/standards , Quality Control
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