|
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
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2019.11.01.306
|
| Download:
|
Request For Article
|
|
|