EC Clinical and Medical Case Reports

“All substances are poisons there is none which is not a poison. The right dose differentiates a poison and a remedy”

                                                                                                                                                              - Paracelsus 1493-1541.

The medicines is very important to fill out 3 criteria for human use. First of all the medicines is necessary to have good quality, and must be safe and effective. The quality of medicines has an impact on public health and quality control should be guaranteed by National Regulatory Agency in the country. The medicines from manufacturer to customer pass in long procedure especially when the medicines are imported the procedure is longer. During this time the medicines can expose incorrect delivery and storage condition and any other mistake in the procedure can detected and avoided from the quality control of medicines in the control laboratory.

Keywords: Quality Control; Medicines; Quality Control Laboratory; safety of medicines and regulatory system.

1. https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/quality-control/trs957-annex1-goodpractices-harmaceuticalqualitycontrol-laboratories.pdf?sfvrsn=ca0c211c_0
2. https://en.wikipedia.org/wiki/Mithridate
3. https://qualitymatters.usp.org/what-pharmacopeia
4. Chris J van Boxtel and Budiono Santoso. “Drug benefits and risks” pg 65.
5. Grainger H S and Sanita A I. “The role of the pharmacopoeia in the control of pharmaceutical preparations”. Annali dell'Istituto Superiore di Sanità3-4 (1975): 305-313.
6. European Pharmacopoeia - Background and Mission.
7. Kucuku M. “Role of Pharmacovigilance on Vaccines Control”. Journal of Rural Medicine 1 (2012): 42-45.
8. Rago L and Santoso B. “Drug regulation: History, Present and Future” pg 65.
9. Recalls, Market Withdrawals, & Safety Alerts.
10. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market (2020).
11. ISO 17025:2017.
12. https://www.edqm.eu/en/omcl-background-and-mission
13. https://www.esteri.it/en/opportunita/nella_ue/opportunita_per_dipendenti_pubblici/taiex/