Quality Assurance for Drugs — Yugoslav Pharmaceutical Industry Situation in Relation to WHO Requirements

Authors

  • Slavko Marković
  • Dženana tatarević

DOI:

https://doi.org/10.5644/Radovi.312

Abstract

Analysis of situation in Yugoslav pharmaceutical industry is described from the point of view of quality assurance introducing. A critical review to legal regulations in the area of drug manufacturing in relation to EEC, FDA and WHO requirements is given and quality assurance system and WHO requirements for manufacture certification are presented. A support is given to the trend of activities taken by other European countries, which are preparing themselves carefully to resist the challenge of requirements regarding EUROPA 92 supported by harmonized standards and rules.

References

uide to Good Pharmaceutical Manufacturing Practice, H. M. S. O., London 1977.

Guide to Good Pharmaceutical Manufacturing Practice, H. M. S. O., London 1983.

M. Macek; Funkcija organiziranja sistema osiguranja kvalitete, Kval. Pouzd., 50 (1988) 210.

M. Minić; Praktičan pristup ugradnji kvaliteta u proizvode za izvoz, Kval. Pouzd., 65 (1989) 69.

M. Macek; Funkcija organiziranja sistema osiguranja kvalitete, Kval. Pouzd., 63 (1989) 32.

JUS A. K. 1.010—014; Savezni zavod za standardizaciju, Beograd, 1987.

Zakon o stavljanju lijekova u promet, SI. list SFRJ, br. 43/86.

Pravilnik o bližim uslovima koji moraju ispunjavati organizacije udruženog rada koje stavljaju lijekove u promet ili obavljaju ispitivanje i kontrolu lijekova koji se upotrebljavaju u medicini, SI. list SFRJ, br. 55/88.

Uputstvo o metodu za laboratorijsko ispitivanje lijekova radi njihovog stav­ljanja u promet, SI. list SFRJ, br. 34/89.

V. Jakić; Akcije za osiguranje kvalitete lijekova u proizvodnji i prometu, Kval. Pouzd., 64 (1989) 11.

B. V. Vrhovac; Kritički prikaz područja lijekova u našoj zemlji u razdob­lju 1985—1988, Pharmaca, 26 (1988) 95.

L. Stefanini-Orešić, M. Perić-Barbarić; Laboratorijsko ispiti­vanje lijekova, Kval. Pouzd., 64 (1989) 23.

Dobra proizvodna praksa 85; Savezni zavod za rad, zdravstvo i socijalnu za­štitu, Beograd, 1986.

Downloads

Published

13.09.1991

Issue

Vol. 25 (1991): Radovi

Section

Works

License

Copyright (c) 2026 Slavko Marković, Dženana tatarević

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

How to Cite

Quality Assurance for Drugs — Yugoslav Pharmaceutical Industry Situation in Relation to WHO Requirements. (1991). Acta Medica Academica, 25, 285-290. https://doi.org/10.5644/Radovi.312