An overview of established practices and parameters to ensure quality of a pharmaceutical product
This project report is submitted in partial fulfilment of the requirements for the degree of Bachelor of Pharmacy, 2017
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BRAC University
2018
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| Онлайн доступ: | http://hdl.handle.net/10361/9486 |
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10361-94862019-09-30T03:16:14Z An overview of established practices and parameters to ensure quality of a pharmaceutical product Akter, Shimu Kabir,Dr. EvaRahman Department of Pharmacy, BRAC University Pharmaceutical product Quality Product Quality Control This project report is submitted in partial fulfilment of the requirements for the degree of Bachelor of Pharmacy, 2017 Cataloged from PDF version of project report. Includes bibliographical references (page 84-86). The quality of a pharmaceutical product is one of the most challenging considerations of the pharmaceutical industry because it is directly related to the patient health and safety. Every pharmaceutical product should be manufactured by a licensed pharmaceutical manufacturer according to the guidelines, which should be stringently monitored by the licensed pharmacist, in order to attain the target quality product. The guidelines that are followed in the pharmaceutical industry are several, such as the ICH guideline, WHO guideline, FDA guideline, etc. A systematic approach needs to be designed and developed with the ‘end’ in mind, in order to ensure quality where the product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches. The impact of starting raw materials and process parameters on product quality must surely be well understood, with an emphasis on product and process understanding and process control. All processes involved must be continually monitored, evaluated, documented and updated in line with the ‘quality by design’ approach to allow for consistent quality throughout product life cycle. The aim of the study was to highlight the various approaches and steps involved, and other relevant considerations that a pharmaceutical company must undertake, whether manufactured in-house or by outsourcing, in order to ensure product quality through ‘quality by design’ approach. Shimu Akter B. Pharmacy. 2018-02-15T09:48:37Z 2018-02-15T09:48:37Z 2017 2017-10-07 Project report ID 12346007 http://hdl.handle.net/10361/9486 en BRAC University project reports are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. 86 pages. application/pdf BRAC University |
| institution |
Brac University |
| collection |
Institutional Repository |
| language |
English |
| topic |
Pharmaceutical product Quality Product Quality Control |
| spellingShingle |
Pharmaceutical product Quality Product Quality Control Akter, Shimu An overview of established practices and parameters to ensure quality of a pharmaceutical product |
| description |
This project report is submitted in partial fulfilment of the requirements for the degree of Bachelor of Pharmacy, 2017 |
| author2 |
Kabir,Dr. EvaRahman |
| author_facet |
Kabir,Dr. EvaRahman Akter, Shimu |
| format |
Project report |
| author |
Akter, Shimu |
| author_sort |
Akter, Shimu |
| title |
An overview of established practices and parameters to ensure quality of a pharmaceutical product |
| title_short |
An overview of established practices and parameters to ensure quality of a pharmaceutical product |
| title_full |
An overview of established practices and parameters to ensure quality of a pharmaceutical product |
| title_fullStr |
An overview of established practices and parameters to ensure quality of a pharmaceutical product |
| title_full_unstemmed |
An overview of established practices and parameters to ensure quality of a pharmaceutical product |
| title_sort |
overview of established practices and parameters to ensure quality of a pharmaceutical product |
| publisher |
BRAC University |
| publishDate |
2018 |
| url |
http://hdl.handle.net/10361/9486 |
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AT aktershimu anoverviewofestablishedpracticesandparameterstoensurequalityofapharmaceuticalproduct AT aktershimu overviewofestablishedpracticesandparameterstoensurequalityofapharmaceuticalproduct |
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