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Elemental Impurities in Drug Products Guidance for Industry - PharmaFacts
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Elemental Impurities in Drug Products Guidance for Industry

Elemental Impurities in

Drug Products Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact (CDER) John Kauffman 314–539–2168, or (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010.

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

June 2016 Pharmaceutical Quality/CMC

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Elemental Impurities in

Drug Products Guidance for Industry

Additional copies are available from:
Office of Communications, Division of Drug Information Center for Drug Evaluation and Research

Food and Drug Administration th 10001 New Hampshire Ave., Hillandale Bldg., 4

Floor

Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research

Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

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U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

June 2016 Pharmaceutical Quality/CMC

 

Contains Nonbinding Recommendations

Draft — Not for Implementation

TABLE OF CONTENTS

  1. INTRODUCTION............................................................................................................. 1

  2. BACKGROUND ............................................................................................................... 2

    1. ICH Q3D............................................................................................................................2

    2. USP General Chapters <232> and <233>.......................................................................3

  3. RECOMMENDATIONS.................................................................................................. 4

    1. New Compendial NDA or ANDA Drug Products .......................................................... 4

    2. New Noncompendial NDA and ANDA Drug Products ................................................. 4

    3. Compendial Drug Products Not Approved Under an NDA or ANDA ........................ 4

    4. Noncompendial Drug Products Not Approved Under an NDA or ANDA .................. 5

    5. Changes to Approved NDAs and ANDAs....................................................................... 5

    6. Documentation Related to the Control of Elemental Impurities..................................6

    7. Quantitative Analytical Procedures for Elemental Impurities ..................................... 7

    8. Validation of Analytical Procedures ............................................................................... 8

    9. Early Adoption..................................................................................................................8

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