Another FDA warning letter due to the lack of appropriate control microbiological contamination!
1. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Why The Concern Over Contamination?
Contamination is a serious concern for the pharmaceutical industry. The presence of contaminants such as non-viable particles, micro-organisms and their endotoxins can reduce or even inactivate the therapeutic activity of the drugs and can adversely affect patients taking the contaminated drugs.
Reputation and Success
Furthermore, it is a serious threat to a company’s reputation and success. It can lead to costly product recalls resulting in financial and image losses, loss of product sales, decreased customer confidence, and in many cases, legal proceedings.
Thus, it is important to know the risk of contamination of all drugs and medicines, whether they are sterile or non-sterile and to implement strict controls to ensure that the final products are consistent, safe, effective and predictable.