| Summary: | Indonesian pharmaceutical companies have shown how to manage the drug
quality by applying Quality Assurance (QA) concept. In accordance with Good
Manufacturing Process (GMP), the concept of QA is intended to provide highquality
drugs to conform the safety, efficacy and acceptability aspects. Many
benefits by implementing QA in the pharmaceutical industries those are not only
able to provide assurance of drugs quality as well as supporting the business
performance through effective and efficient process improvement.
PT. Duta Kaisar Pharmacy is one of the pharmaceutical industry in Indonesia
committed to ensure their drugs quality by applying QA, but it is still however
necessary to evaluate the benefits of QA regarding the drugs quality and process
performances. Based on unit sales reports in 2005 - 2006, Antalgin injection 250
mg / ml is a top pareto product owned by PT. Duta Kaisar Pharmacy and therefore
to reflect the influence of the QA, this research is carried out to analyze the impact
of the QA application regarding the quality and production efficiency of Antalgin
250 mg / ml by comparing the product quality and production efficiency before
and after QA implementation.
The results of observation illustrate there was improvement of QA concept in
PT. Duta Kaisar Pharmacy by doing calibration, machinery and personnel
qualification, supplier qualification, process validation, change control, deviation
handling, and batch releasing. The results of analysis present that QA improved
quality of Antalgin injection by reducing the standard deviation of the content of
active ingredient from 1.08% to 0.47% and improving the process capability
index (Cpk) from 3.99 to 4.45 so could assurance the consistency of Antalgin�s
injection production process to meet the determined content of active ingredient
specification. Implementation of QA could also reduce the standard deviation of
the filled volume of Antalgin injection significantly from 0.03 ml to almost 0
(zero) deviation so was able to increase production process consistency and
capability to meet the specification. Simultaneously, QA implementation
presented a significant production efficiency improvement of Antalgin injection
from 87.93% to be 93.55% so was able to meet the established company standard
for at least 90%. This significant efficiency improvement gave company margin
contribution by increasing the product margin percentage from 48.00% to 49.05%
(increase 2.2%) through reduction of cost of goods (COGs) Antalgin injection
thereby will increase the percentage of corporate profits and may certainly
enhance the company business sustainability.
|
|---|