ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY

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 be...

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Main Authors: , LORDLY NUNKI, S.FARM., APT., , Prof. Dr. Sri Sulihtyowati Soebagyo, Apt.
Format: Thesis
Published: [Yogyakarta] : Universitas Gadjah Mada 2012
Subjects:
ETD
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author , LORDLY NUNKI, S.FARM., APT.
, Prof. Dr. Sri Sulihtyowati Soebagyo, Apt.
author_facet , LORDLY NUNKI, S.FARM., APT.
, Prof. Dr. Sri Sulihtyowati Soebagyo, Apt.
author_sort , LORDLY NUNKI, S.FARM., APT.
collection UGM
description 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.
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spelling oai:generic.eprints.org:989292016-03-04T08:47:27Z https://repository.ugm.ac.id/98929/ ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY , LORDLY NUNKI, S.FARM., APT. , Prof. Dr. Sri Sulihtyowati Soebagyo, Apt. ETD 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. [Yogyakarta] : Universitas Gadjah Mada 2012 Thesis NonPeerReviewed , LORDLY NUNKI, S.FARM., APT. and , Prof. Dr. Sri Sulihtyowati Soebagyo, Apt. (2012) ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY. UNSPECIFIED thesis, UNSPECIFIED. http://etd.ugm.ac.id/index.php?mod=penelitian_detail&sub=PenelitianDetail&act=view&typ=html&buku_id=55578
spellingShingle ETD
, LORDLY NUNKI, S.FARM., APT.
, Prof. Dr. Sri Sulihtyowati Soebagyo, Apt.
ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY
title ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY
title_full ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY
title_fullStr ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY
title_full_unstemmed ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY
title_short ANALISIS PENGARUH PENERAPAN �QUALITY ASSURANCE� TERHADAP MUTU DAN EFISIENSI PRODUKSI SEDIAAN INJEKSI ANTALGIN 250 MG/ML DI PT. DUTA KAISAR PHARMACY
title_sort analisis pengaruh penerapan a��quality assurancea�� terhadap mutu dan efisiensi produksi sediaan injeksi antalgin 250 mg ml di pt duta kaisar pharmacy
topic ETD
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AT profdrsrisulihtyowatisoebagyoapt analisispengaruhpenerapanaqualityassuranceaterhadapmutudanefisiensiproduksisediaaninjeksiantalgin250mgmldiptdutakaisarpharmacy