233
Views
19
CrossRef citations to date
0
Altmetric
Perspective

Reaching international GMP standards for vaccine production: challenges for developing countries

, , &
Pages 559-566 | Published online: 09 Jan 2014

References

  • Federal Register. Drugs, current good manufacturing practices in manufacture, processing, packing, or holding. Part 133, 28 FR 6385, 20 June, 1963.
  • Expert Committee on Specifications for Pharmaceutical Preparations. Good manufacturing practices for pharmaceutical products. Technical Report Series823, Annex 1 (1993).
  • Expert Committee on Biological Standardization. Good manufacturing practice guidelines for biological products. Technical Report Series822, Annex 1 (1992)
  • Expert Committee on Biological Standardization. Guidelines for national authorities on quality assurance for biological products. Technical Report Series822, Annex 2 (1992).
  • ICH Harmonized Tripartite Guideline Q7A: GMP guide for active pharmaceutical ingredients. Final Version. November 2000.
  • Milstien JB, Gibson JJ. Quality control of BCG vaccines by the World Health Organization: a review of factors that may influence vaccine effectiveness and safety. Bull. WHO68(1), 93–108 (1990).
  • Milstien J, Batson A, Meaney W. A systematic method for evaluating the potential viability of local vaccine producers. Vaccine15(12/13), 1358–1363 (1997).
  • Frew SE, Rezaie R, Sammut SM, Monali R, Daar AS, Singer PA. India’s health biotech sector at a crossroads. Nat. Biotechnol.25(4), 403–417 (2007).
  • WHO. Executive summary of meeting on improving vaccine regulatory capacity, December 2007. Wkly Epidemiol. Record.83(20) 181–184 (2007).
  • Expert Committee on Biological Standardization. Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. WHO Technical Report Series760, Annexes 1 and 2 (1988); 771, Annexes 2 and 3 (1988); 786, Annex 1 (1989).
  • Wade N. Division of Biologics Standards scientific management questioned. Science175(25), 966–970 (1972).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.