Assessment of Compliance with the Good Manufacturing Practice Criteria for Drinking Water in Sealed Containers among Manufacturers in Chachoengsao Province, Thailand

Paninitorn Ngamsiri, Assadang Polnok

Abstract


Objectives: To assess the manufacturers’ compliance with the Good Manufacturing Practice (GMP) criteria for drinking water in sealed containers by the self-assessment and experts. Methods: In this descriptive study, manufacturers and experts assessed all 53 plants in Chachoengsao Province using a questionnaire adapted from GMP inspection form mandated by the Thai Food and Drug Administration. Many samples of the drinking water were collected for chemical, physical and microbiological tests. Results: The self-assessment reviewed that 22.64% of the manufacturers were non-compliant with the GMP criteria, especially for Domain 9 (documentation and report) being the most failed aspect. Based on the expert assessment, 37.74% of the manufacturers were non-compliant with the GMP criteria. Similar to the self-assessment, Domain 9 was the most failed item followed by Domain 6 (water filling) that was seriously violated because of performing outside the filling room. In addition, domain 6 was assessed as compliant by the self-assessment but was found non-compliant by the experts up to 11 places (20.75%). Laboratory tests showed that 28.30% of them did not meet the microbiological standard with the presence of coliform bacteria. Water products compliant with GMP’s Domain 6 standards were more likely to pass the microbiological test. Conclusion: Domain 6 (water filling) was found to be a serious violation and had the highest discrepancy between the self-assessment and expert assessment. Thus, the manufacturers and regulators should be aware of its importance. A preventive measure should also be initiated to ensure the operational procedure is in accordance with the GMP.

Keywords: Drinking water in sealed containers, Good Manufacturing Practice, GMP, self-assessment


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Thai Pharmaceutical and Health Science Journal - วารสารไทยเภสัชศาสตร์และวิทยาการสุขภาพ

ISSN: 1905-3460

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