Introduction:

The use of human placenta as pharmaceutical raw material is due to the content of biologically active substances. The Placental Histotherapy Center (HISPLACEN) researches, develops, produces, and markets products of placental origin.

Objective:

to analyze the assurance and control process to certify the quality of the human placenta as a raw material in the biopharmaceutical industry, based on the bioethical approach.

Material and Methods:

A descriptive and analytical study was carried out. The process of quality assurance and control of the human placenta in HISPLACEN, and its implementation in the period 2017-2021 was defined as the research object. The documentation of the institutional Quality Management System, Good Practices regulations of the CECMED, and the scientific literature on Bioethics were reviewed.

Results:

The stages of the quality assurance and control of the placenta process and its derived products were described and analyzed, highlighting the application of the bioethical approach in its implementation. The correspondence of a human and environmental ethics of multidisciplinary interrelation and between the actors involved in the entrepreneurial ecosystem was identified. All this focused on the dimensions related to science and technology in the manufacture of medicines.

Conclusions:

The compliance of bioethical principles in the certification of human placentas was evidenced, which promoted the development of a process typified by comprehensiveness, functionality, efficacy, and robustness. This biological organ used as raw material was approached from multidimensionality -scientific, technological and bioethical - of the process focused on a common objective: guaranteeing human health and well-being, together with environmental protection.

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