Buenos Aires, January 12 (NA) – The National Administration of Medicines, Food and Medical Technology (ANMAT) has suspended the production activities of two laboratories for several critical violations of Good Pharmacovigilance and Manufacturing Practices. Through two official statements, ANMAT authorities announced that the activities of the companies Solkotal S.A. and Biotenk S.A. have been disabled. The first for violations of Good Manufacturing Practices, while the second for critical infringements of Good Pharmacovigilance Practices. During an inspection conducted by the National Institute of Medicines (INAME) at Solkotal S.A. laboratories, deficiencies were detected, such as the absence of key and qualified personnel; lack of an adequate quality management system, deficiencies in facilities and maintenance; incorrect segregation and labeling of materials and products; clean areas without current requalification; critical equipment without calibration or maintenance; and shortcomings in the production and quality control sectors. Likewise, according to the document accessed by the Argentine News Agency, it was indicated that the company carries out the complete manufacturing of injectable products owned by Laboratorio P.L. Rivero y CIA S.A., as well as outsourced activities without the corresponding sanitary authorization or supporting documentation. “These are violations of Good Manufacturing Practices with critical observations, which implies the existence of an imminent health risk to the population's health,” they emphasized. Regarding the company Biotenk S.A., they informed that INAME also conducted an inspection and confirmed: the non-existence of a formal Pharmacovigilance area; absence of an adequate system for receiving, evaluating, filing, and reporting adverse reactions; lack of sending notifications to ANMAT; non-existence of a systematic review of scientific literature; absence of Periodic Safety Update Reports (PSURs); lack of updating of leaflets and standard operating procedures; the absence of training; and lack of sufficient human and material resources for the proper performance of Pharmacovigilance functions. According to the Standard Operating Procedure “Conducting Good Pharmacovigilance Practices Inspections”, ANMAT granted the company the corresponding deadline to submit a Corrective and Preventive Actions (CAPA) plan, taking into account the observations and violations detected. However, they did not submit the required plan. This company markets over-the-counter and mass-use medicines, so the lack of implementation of a functional Pharmacovigilance system “increases the health risk to the population's health”. Consequently, and in order to protect public health, it was ordered the preventive inhibition of the company's production activities.
