martes, 23 de mayo de 2017

FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
The FDA advises drug manufacturers of non-sterile, water-based drug products that there have been recent product recalls due to Burkholderia cepacia complex (BCC or B. cepacia) contamination. BCC and other water-borne opportunistic pathogens are among the contaminants that can be found in pharmaceutical water systems. People exposed to BCC are at an increased risk for illness or infection, especially patients with compromised immune systems.
Details are posted on FDA’s website at:
Specifically, the FDA is reminding drug manufacturers to:
  • Establish procedures designed to prevent objectionable microorganism contamination of non-sterile drug products, such as procedures to assure adequate quality of incoming materials, sanitary design, maintenance and cleaning of equipment, production and storage time limitations, and monitoring of environmental conditions.
  • Use scientifically sound and appropriate acceptance criteria and test procedures to assure that drug product components (including pharmaceutical water) and finished drug products conform to appropriate quality standards.
  • Provide appropriate drug product specifications (tests, methods, and acceptance criteria) in applications submitted to the FDA.  As appropriate, additional laboratory tests may be needed to determine whether products are suitable for release.
  • Ensure that the methods used to test finished drug products prior to release for distribution are appropriately validated, accurate, sensitive, specific and reproducible.
  • Test in-process materials during the production process using valid in-process specifications to assure, among other things, that the drug product will meet its final specification, including criteria for absence of microbial contamination, where appropriate.
  • Investigate any failure to meet specifications, including other batches of the same drug product and other drug products that may have been associated with the specific failure or disrepancy, and implement appropriate corrective and follow-up actions to prevent recurrence.
Adverse events or quality problems experienced with the use of a non-sterile water-based drug product should be reported to FDA’s MedWatch Adverse Event Reporting program.

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