Lyt når som helst, hvor som helst

Nyd den ubegrænsede adgang til tusindvis af spændende e- og lydbøger - helt gratis

  • Lyt og læs så meget du har lyst til
  • Opdag et kæmpe bibliotek fyldt med fortællinger
  • Eksklusive titler + Mofibo Originals
  • Opsig når som helst
DK - Details page - Device banner - 894x1036

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Sprog
Engelsk
Format
Kategori

Økonomi & Business

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.

GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. As a bonus, this package contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for GMP audit is also included based on risk management criteria. An exam complements the extra material.

© 2014 ASQ Quality Press (E-bog): 9780873898294

Release date

E-bog: 30. april 2014

Andre kan også lide...

Vælg dit abonnement

  • Over 600.000 titler

  • Download og nyd titler offline

  • Eksklusive titler + Mofibo Originals

  • Børnevenligt miljø (Kids Mode)

  • Det er nemt at opsige når som helst

Flex

For dig som vil prøve Mofibo.

89 kr. /måned
  • 1 konto

  • 20 timer/måned

  • Gem op til 100 ubrugte timer

  • Eksklusivt indhold hver uge

  • Fri lytning til podcasts

  • Ingen binding

Prøv gratis
Den mest populære

Premium

For dig som lytter og læser ofte.

129 kr. /måned
  • 1 konto

  • 100 timer/måned

  • Eksklusivt indhold hver uge

  • Fri lytning til podcasts

  • Ingen binding

Start tilbuddet

Unlimited

For dig som lytter og læser ubegrænset.

149 kr. /måned
  • 1 konto

  • Ubegrænset adgang

  • Eksklusivt indhold hver uge

  • Fri lytning til podcasts

  • Ingen binding

Start tilbuddet

Family

For dig som ønsker at dele historier med familien.

Fra 179 kr. /måned
  • 2-6 konti

  • 100 timer/måned pr. konto

  • Fri lytning til podcasts

  • Kun 39 kr. pr. ekstra konto

  • Ingen binding

2 konti

179 kr. /måned
Prøv gratis