IMPLEMENTATION OF HOLD-TIME AND ANALYSIS OF ITS EFFECT ON THE QUALITY PRODUCT OF PARACETAMOL SYRUP BASED ON A RISK ASSESSMENT APPROACH IN PHARMACEUTICAL INDUSTRY
The manufacturing process of pharmaceutical products goes through several stages before becoming the finished products. Hold time data of products is needed to provide assurance that the temporarily stored products for the next stage of manufacturing process does not change the quality during hol...
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| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/84102 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | The manufacturing process of pharmaceutical products goes through several stages
before becoming the finished products. Hold time data of products is needed to provide
assurance that the temporarily stored products for the next stage of manufacturing
process does not change the quality during hold time. The purpose of this research is to
obtain the related data to Critical Quality Attribute (CQA) during hold time by
implementation of hold time study based on risk assessment in syrup dosage form of
paracetamol. The bulk product of Paracetamol syrup was stored in a 316L stainless
steel mixing tank for 10 days with suitable storage conditions for the production room.
Sampling for testing the CQA parameters, including product appearance test,
identification and assay test of paracetamol, determination of total aerobic microbials
count and total combined yeasts/molds count, identification of pathogenic bacterial
contamination (E. Coli), determination of paracetamol impurities (4-aminophenol), as
well as determination of specific gravity, viscosity and pH were conducted daily. Based
on the results of the study, the CQA parameters still meet the existing acceptance
criteria until the 10
th
day. Trend analysis was performed with the Neumann test and test
results were found that the value of parameter test to be greater than the value of table,
then it indicates that there is no trend in the data. The results of data distribution test
showed that the assay of paracetamol was normally distributed, while the viscosity and
pH were not normally distributed. Stability testing was performed after the 10
th
day and
the test results showed that the CQA parameters still met the established acceptance
criteria. Based on the overall results, it can be concluded that the hold time of the bulk
product of Paracetamol syrup of PT. Z can be stored for 10 days without any
deterioration in quality or stability of the finished product.
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