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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Recent insight into critical concerns in international quality regulations governing the pharmaceutical industry: A Review

Author: DALIA ABOUHUSSEIN*, PETER SABRY, HEND M MOGHAWRY
Abstract: The Pharmaceutical industry is an essential trade that involves critical processes which have a direct impact on human health. Manufacturers should build in quality within each stage by applying the national &/or international quality guidelines related to this aspect. Since World Health Organization (WHO) is concerned with all matters that affect the human health, subsequently it issued several international guidelines and technical reports to support and warrant the quality of each step of this vital industry all around the world. So, our purpose is to highlight the critical concerns in the latest updated good practices to ensure the quality of the manufactured pharmaceutical products. WHO guidelines and annexes were searched. Relevant guidelines that administer the least requirements and the recommendations from the very beginning of the predevelopment stage by desk research in the laboratory until the pharmaceutical product is distributed in the market. WHO updates their guidelines or issues a new one whenever a certain observation or feedback is repeatedly noticed that may be thought to be critical to human health or may lead to an unreliable decision. However, it is recommended to set up a review date for each guideline to ensure its efficiency and suitability of use.
Keyword: Pharmaceutical Industry Regulatory Requirements – Development – Good Manufacturing Requirements – Clinical Trial – Distribution
DOI: https://doi.org/10.31838/ijpr/2019.11.01.306
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