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

Standards for vaccine production have been increasing at a rapid rate. Current standards of good manufacturing practice (GMP) had been thought to be out of the reach of developing country vaccine producers, many of whom are in the public sector, overseen by unvalidated national regulatory authorities (NRAs). With the advent of the GMP regulations in 1963 and their application to vaccine production, even many industrialized country manufacturers with stringent NRA oversight had difficulties. This article assesses the ability of developing country manufacturers to meet GMP by the only currently available global indicator: WHO prequalification. As recently as 1996, no developing country NRA was considered able to enforce GMP compliance. That number increased to four in 2002 and six in 2006, with a concomitant increase in the number of manufacturers considered to be operating to GMP standards. Examples of the difficulties faced by manufacturers in achieving this are given, as well as implications for the future vaccine market.