Concepedia

Good Manufacturing Practice

Good Manufacturing Practice is a regulatory quality assurance system that establishes minimum requirements for manufacturing processes, facilities, personnel, and quality control to ensure pharmaceutical products are consistently produced and controlled according to their specified quality standards.

345

Publications

12.6K

Citations

1.4K

Authors

529

Institutions

Publications per year

2017–2026

105

Variants

Gmp

Parents

Children

Publications

345

Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

Lawrence X. Yu · Pharmaceutical Research · 2008 · 1.2K citations

, , +14

Low vs. high-fidelity prototyping debate

Jim Rudd, Ken Stern, Scott Isensee · interactions · 1996 · 377 citations

, , +6

Disposable masks: Disinfection and sterilization for reuse, and non-certified manufacturing, in the face of shortages during the COVID-19 pandemic

Juan Carlos Rubio‐Romero, María del Carmen Pardo-Ferreira, Juan Antonio Torrecilla-García et al. · Safety Science · 2020 · 291 citations · Full text

, , +15

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

Hang Yin, J Hetzke, Piotr Kozarewicz et al. · PubMed · 1969 · 261 citations

, , +15

National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

Camillo Ricordi, Julia Goldstein, Appakalai N. Balamurugan et al. · Diabetes · 2016 · 197 citations · Full text

, , +17

1–5 of 345

Authors

1.4K

  1. KG
    Koni Grob

    Department of Health Canton of Zurich, Switzerland

    3 publications · 45 citations

    3

    h-index

  2. WF
    William F. Kiesman

    Biogen (United States), United States

    3 publications · 51 citations

    3

    h-index

  3. HH
    Harry H. S. Fong

    University of Illinois Chicago, United States

    2 publications · 43 citations

    2

    h-index

  4. MS
    Miranda Suchomel

    Medical University of Vienna, Austria

    2 publications · 49 citations

    2

    h-index

  5. HY
    Helen Yang

    Brigham and Women's Hospital, United States

    2 publications · 37 citations

    2

    h-index

1–5 of 1.4K

Institutions

529

  1. University of Lausanne

    Lausanne, Switzerland

    4 h-index

    37 publications

    909 citations

  2. Eli Lilly (United States)

    Indianapolis, United States

    4 h-index

    23 publications

    845 citations

  3. National Institutes of Health

    Bethesda, United States

    4 h-index

    9 publications

    967 citations

  4. United States Food and Drug Administration

    Silver Spring, United States

    4 h-index

    4 publications

    1.3K citations

  5. University of Birmingham

    Birmingham, United Kingdom

    4 h-index

    16 publications

    1K citations

  6. Pfizer (United States)

    New York, United States

    4 h-index

    8 publications

    420 citations

  7. Roche (Switzerland)

    Basel, Switzerland

    4 h-index

    12 publications

    172 citations

  8. University of Minnesota

    Minneapolis, United States

    3 h-index

    5 publications

    628 citations

1–8 of 529

Venues

  1. PubMed

    Repository · 27 publications · 930 citations

    17

    h-index

  2. Food Control

    9 publications · 284 citations

    9

    h-index

  3. Cytotherapy

    7 publications · 281 citations

    7

    h-index

  4. Organic Process Research & Development

    6 publications · 127 citations

    6

    h-index

  5. Journal of AOAC International

    4 publications · 113 citations

    4

    h-index

1–5

See also

Good Manufacturing Practice

Core Requirements

Quality Control

Documentation Systems

Validation