Introduction
On June 6, 2022, it was published in the Official Gazette the Exempt Resolution No. 1.881 dated April 29, 2022, issued by the Institute of Public Health, which establishes the obligation to implement a test method for the determination of the Burkholderia Cepacia complex, objectionable microorganisms, in raw materials and finished products that it indicates.
In consideration of the seriousness of the presence of Burkholderia Cepacia complex (BCC) in non-sterile drugs containing water in their composition, because it causes a series of risks, especially to immunocompromised persons, and is characterized by its high degree of resistance to antibiotics, and considering the existence of a series of studies that determine control measures to verify the absence of this in water, raw materials and finished pharmaceutical products, and considering the need to establish a reinforced surveillance in the production and quality assurance activities of the manufacturers of pharmaceutical products to prevent risks of microbiological contamination, this resolution is issued, which establishes:
1. The obligation for quality control laboratories belonging to pharmaceutical production laboratories or external quality control laboratories to implement an appropriate microbiological test method for the determination of Burkholderia Cepacia complex, in order to ensure that the components of a pharmaceutical product and the batch of the finished product prior to distribution are free of this contaminant.
2. The mandatory incorporation of the absence of Burkholderia Cepacia complex as a microbiological parameter in the finished product specifications of non-sterile water-based drugs.
3. Implement the analytical method for the detection of Burkholderia Cepacia complex the chapter <60> Microbiological Examination of Nonsterile Products: Tests for Burkholderia Cepacia Complex in the United States Pharmacopoeia (USP), or another validated detection method.
4. Timelines for implementation and inspection.
Contact
If you require additional information on this matter, please contact Andrea Abascal (aabascal@jdf.cl), and/or Rocío Vergara (rvergara@jdf.cl).
