Purpose: To investigate the
microbiological quality of blister-packed tablets
manufactured and marketed in Jordan in order to assess
Good Manufacturing Practice by pharmaceutical industries
in the country.
Methods: A total of 66 items of 22
registered blister-packed tablet brands were purchased
from community pharmacies in Amman. All the items were
investigated for total bacterial count and the presence
of specified microorganisms using compendial procedures.
Results: Out of 66 items purchased,
forty eight (72.7 %) products were free from microbial
contamination, while 11 (16.7 %) harbored bacteria in
counts < 102 cfu/g. The remaining 7 (10.6 %) items
contained counts between 102 and < 103 cfu/g. The most
commonly encountered contaminant was Bacillus species
but specified objectionable bacteria such as Escherichia
coli and Staphylococcus aereus were not detected.
Aspergillus and Penicillium species were isolated in low
numbers from few products. Six of the products with the
highest stratified bacterial count were manufactured by
one company and were also found to be contaminated with
Aeromonas species.
Conclusion: This study demonstrates
that blister-packed tablets produced by Jordanian
pharmaceutical companies are within acceptable
microbiological quality but the detection of microbial
load in some brands close to the maximum allowable limit
suggests the need for better adherence to GMP in the
country.
Keywords:
Blister pack, Community
pharmacy, Good Manufacturing Practice, Microbial
contamination, Quality control, Tablets