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 |