Potent Compound Corner

Brazil/ANVISA joins the Pharmaceutical Inspection Co-operation Scheme (PIC/S)

November 30, 2020

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) organization announced today that Brazil/ANVISA (“Agencia Nacional de Vigilancia Sanitaria”) has been formally accepted into the PICs organization starting January 1st, 2021. According to the PIC/S website, “A paper assessment was carried out followed by an on-site assessment visit which took place in October 2019, after a reorganisation at ANVISA. The assessment report was finalised in the course of 2020.” The PIC/s organization also noted that “This is the first time in PIC/S’ history that an assessment process is completed by written procedure rather than at a Committee meeting. This was due to the situation with Covid-19 which prevented a Committee meeting taking place in 2020.”

About PIC/S

Based in Geneva, Switzerland, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal cooperative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. The PIC/S organization is open to any regulatory authority having a comparable GMP inspection system. Currently, PIC/S comprises fifty-three participating regulatory authorities throughout the world (Europe, Africa, America, Asia and Australasia). Starting January 1st, 2021, once Brazil joins, PIC/S will have fifty-four participating regulatory authorities. Other countries that are currently in the PIC/s application process include Armenia, Bulgaria, and Saudi Arabia.

Impact on cGMP Regulatory Compliance in Brazil

While a specific timeline for coming into compliance with all the PIC/S requirements has not been stated in the PIC/S, all pharmaceutical manufacturers in Brazil should carefully review the PIC/S guidelines and publications to determine their impact. For pharmaceutical manufacturers processing multiple products, the PIC/S Guideline on Setting Health Based Exposure Limits for us in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities will be key and required careful review.

Affygility Solutions is here to help with your HBEL needs

The expert toxicologists at Affygility Solutions are available to assist you with all your health based exposure limit (HBEL) needs (also known as acceptable daily exposure (ADE) limits or permitted daily exposure (PDE) limits). Currently, our award-winning OEL Fastrac platform has over 1,800 expertly-prepared OEL/ADE monographs in its catalog. Don’t see your specific active pharmaceutical ingredient in the OEL Fastrac catalog? No problem, please contact us at Affygility Solutions and submit a request. OEL Fastrac monographs with ADE have been used by pharmaceutical manufacturers in over 65 countries, including Brazil.

Published November 30, 2020

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