Being granted with a Good Manufacturing Practices Certification (GMPC) takes years of research, hard work, and focused efforts. According to the definition of Anvisa, a GMPC must be issued to each manufacturing site, addressing production lines, pharmaceutical forms, special therapeutic classes and risk classes of the products for which the company has been inspected.
A GMPC is a warranty for patients that the manufacturing plant where the medicine was produced strictly follows all applicable regulations.
For being allowed to start manufacturing Biological APIs, Cristália had to receive the following certifications:
The Biotechnology manufacturing plant has been granted, on March 17th, 2014, with a GMPC for APIs (Biological Pharmaceutical Inputs). The decision to grant the certification was published on the Brazilian Official Gazette, under Resolution RE # 934.
Cristália’s second GMPC granted to the Biotechnology- Anaerobics manufacturing plant was published on the Brazilian Official Gazette under Resolution # 4254, on November 30th, 2014.
Both GMPCs have been granted by the Brazilian regulatory authority (ANVISA), after a thorough technical inspection, confirming that the company follows all Brazilian regulations, in accordance to WHO’s (World Health Organization) guidelines.
Cristália had its GMPC renewed for biologicals manufacturing, consistently to the World Health Organization’s guidelines. The certification was granted on January 17th, 2017, and is valid through January 16th, 2019.
This single certification applies to both Biotechnology Manufacturing Plants – the Biotechnology site, and the Biotechnology-Anaerobics site.