Inspection Cooperation Scheme Views of Pharmaceutical Manufacturers in Thailand about the Code of Good Manufacturing Practice of the Pharmaceutical Inspection Cooperation Scheme

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Somying Pumtong
Sathaporn Nimkulrat
Pannipa Akanithapichat
Kunyada Nilwas
Benjaporn Kingrungpetch
Dusadi Suriyapanpong

Abstract

The aim of this survey is to investigate views of pharmaceutical manufacturers concerning the Code of Good Manufacturing Practice (GMP) of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Between 19 October and 5 December 2007, data were collected from all modern pharmaceutical manufacturers in Thailand (n=165) using mailed questionnaires. Data were analyzed using descriptive statistics and ANOVA to compare differences across the manufacturer business size as well as spearman correlation to investigate the associations among variables. Fifty-six questionnaires were completed (response rate 34%). The average age of the modern pharmaceutical manufacturers in this study was 35 years. According to business size by small and medium enterprises (SMEs), the manufacturers were divided into three groups: small, medium, and large-sized businesses (23.2%, 50.0% and 19.6% respectively). Thirty-three of the manufacturers (59%) are exporters of drug products. The respondents were asked to assess their potential to achieve the GMP of PIC/S and the data revealed that the majority rated at a moderate to high level. There was a statistically significant difference in overall potential to achieve the GMP of PIC/S scores among the three groups (p < 0.001) and the small-sized businesses had the lowest mean scores. Regarding views of obstacles to achieve the PIC/S GMP, the comparison demonstrated a significant difference for size of manufacturer business (p=0.005). The small-sized businesses had significantly higher obstacle scores. The major obstacle faced was financial difficulties (i.e. investment in infrastructure: machines, equipments and premises). Additionally, there were correlations between sale value and overall potential; and sale value and obstacles to achieve the GMP of PIC/S (r=0.553, p < 0.001 and r=-0.400, p=0.004 respectively). Forty-five percent of respondents suggested that Food and Drug Administration (FDA) should not enforce the GMP of PIC/S upon all modern pharmaceutical manufacturers at present as such an action could cause difficulties in management and expenditure. However, 30% agreed to comply with the GMP of PIC/S as they believed that the new GMP could increase the standards of manufacturing practice. Consequently, the image of pharmaceutical manufacturers in Thailand would be improved. The findings could be used by the FDA in order to provide a suitable option for modern pharmaceutical manufacturers and introduce a policy to explore and ultimately improve the standard of manufacturing practice in Thailand.

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Pharmacy

References

Pharmaceutical Inspection Cooperation Scheme. (a) Lists of participating authorities (&observers). http://www.picscheme.org/index.php?p=member. Accessed on March 27, 2008.

Pharmaceutical Inspection Cooperation Scheme. (b) Benefits of PIC/S membership. http://www.picscheme.org/index.php?p=benefi. Accessed on March 27, 2008.

The Food and Drug Administration. Ministry of Public Health. Name list of Modern Medicinal GMP Conformance Manufacturers. http://WWW.fda.moph.go.th/fdanet/html/product/drug/fda_drug/gmpenglish.htm. Accessed on March 27, 2008.