• Shuffle
    Toggle On
    Toggle Off
  • Alphabetize
    Toggle On
    Toggle Off
  • Front First
    Toggle On
    Toggle Off
  • Both Sides
    Toggle On
    Toggle Off
  • Read
    Toggle On
    Toggle Off
Reading...
Front

Card Range To Study

through

image

Play button

image

Play button

image

Progress

1/26

Click to flip

Use LEFT and RIGHT arrow keys to navigate between flashcards;

Use UP and DOWN arrow keys to flip the card;

H to show hint;

A reads text to speech;

26 Cards in this Set

  • Front
  • Back

criteria to fulfill for medicinal products

efficacy, quality, safety

GXP

research and development --> in research institutes, use of GDP

GLP

in preclinic --> certified test facilities

GCP

in clinic --> clinical facilities

GMP

in manufacturing --> certified manufacturers


--> quality assurance system which ensures that medicinal products are consistently produced and controlled according to their quality standards, appropriate to their intended use, defined in the admission dossier of the pharmaceutical company

head of production

responsible for gmp conform production

head of quality control

responsible for the gmp conform quality control of the finished medicinal product with reference to specification

qualified person

overall responsibility of the final product including production

head of distribution

responsible for the offer for sale

reasons for GMP

generica skandal --> faked admission dossiers, not realized studies, not produced batches of finished product, not documented oos results, FDA officers in corruption

requested in production

--> qualification of equipment


--> validation of processes


------> have to be carried out according to established processes: 1. Planning, 2. realization, 3. reporting, 4. revalidation

admission of finished medicinal products

based on national drug law


--> proof of efficiacy, safety, quality


--> limited to 5 years

change control procedure

--> registration --> evaluation --> decision --> realization


... of planned changes

GMP conform documents

--> counterfeit proofed


--> readble typeface/ clearly arranged


--> faultless and understandable


--> easily checkable


--> approved, dated, signed several times


--> checked and updated regularly


--> created just in time

description of procedures

--> cleaning


--> change of clothes


--> supervision of the environment


--> sampling


--> sample work up


--> usage of technical equipment

compulsory SOPs

-->sample and reference standards


--> technical equipment


--> methods


--> documentation reporting, archiving


--> computerized systems


--> outsourcing


--> handling of oos rules


procedures in case of deviation

--> deviation note


--> change request


--> investigation report

reference standards SOP

--> delivery/ identification


--> purity


--> labelling


--> usage and storage


--> retention sample


--> withdrawal


--> disposal

technical equipment SOP

--> labelling


--> handling of equipment


--> performance test ( calibration, specification, handling of failed tests)


--> maintenance


--> cleaning


--> software validation


--> backup procedure


--> change control


computerized systems SOP

--> handling


--> responsibilities


--> acceptance test


--> change control


--> backup procedures


--> make electronic data readable ( human readable form)


--> disaster recovery


--> archiving of e data


material/ reagent SOP

--> clear labelling ( identity, concentration, exspiring data, storage conditions)


--> documentation (origin, manufacturing date, content

recording of raw data

-->codification of studies


--> handling ( definition and authorization)


--> storage


--> validation of data management system (LIMS)


--> preparation of standard operating procedures (creating, changing, updating, authorization, distribution and archiving, chronological filling)

reporting SOP

--> content


--> description of the study


--> codation system


--> description of drug and product


--> sponsor and contract lab


--> timelines


--> mat and meth


--> results/ discussion


--> retention/ archiving


--> QA statement


--> release of qualified person

archiving SOP

--> nomination of archivist


--> access regulation


--> taking/ return of documents


--> numbering of documents


--> appropriate storage

documents to be archived

--> laboratory and production: organigramm, room plans, equipment lists


--> QA: master schedule, inspection reports, SOPs


--> staff: training, job description


--> equipment: calibration, maintenance, repair-records

quality assurance SOP

--> planning, enforcement, documentation and reporting of inspections


--> lab based inspections


--> production based inspections


--> study based inspections