What about Personal Care and other Non-Drug Products?
Although personal care and other non-drug products are not regulated as tightly as drug products, the US Food, Drug and Cosmetic Act establishes that owners of such products are responsible for the safety of their products as they are introduced into interstate commerce.
For FDA, the “safety” of products includes being free of microbial contamination which could pose a risk to public health. This being the case, it is prudent for manufacturers of water-based non-drug products to also observe FDA’s current requirements for drug manufacturers, and to voluntarily apply those elements which may factor into the quality of their finished products.
The importance of this recommendation is underscored by the fact that US distributed water-based non-drug products are among those which have already been recalled due to confirmed or suspected Burkholderia cepacia contamination.
Testing for Burkholderia cepacia
FDA now expects manufacturers of water-based non-sterile drug products to test for the presence of BCC in their products. In the absence of an “official” (compendial) test procedure for Burkholderia cepacia, FDA requires that any procedure utilized for this purpose must be validated.
It is important to note that the United States Pharmacopeia (USP) is currently working towards the development of an official procedure for the testing of Burkholderia cepacia in non-sterile water-based drug products. Once published, it is expected that most if not all manufacturers will employ the USP procedure in their testing for Burkholderia cepacia.
A Final Summary
- Burkholderia cepacia complex (BCC) now poses a significant health risk to specific population groups within the US.
- Non-sterile water-based drug and non-drug products have been shown to contain Burkholderia cepacia contamination and have been included in product recalls within the US.
- FDA now expects drug manufacturers to monitor their finished products for the presence of B. Cepacia contamination.
- There currently is no “official” testing method for Burkholderia cepacia, although the USP is working towards the development of such a procedure. Until the “official” method is published, FDA requires that testing methods used for this purpose must be validated.
- Since non-drug products are among those recalled for B. Cepacia contamination, it is prudent for manufacturers of such products to implement suitable specifications and controls to prevent microbial contamination of their products, and to conduct monitoring for Burkholderia cepacia in their water-based products and water systems.
How Can CPTSM Labs Assist with your Burkholderia cepacia testing?
CPTSM Labs Microbiological Division scientists have developed, validated and now employ a procedure for testing Burkholderia cepacia complex (BCC) in raw materials and non-sterile water-based products. This procedure and its validation have previously been reviewed by FDA.
This method is ready to be applied to your raw materials, in-process samples and finished products. Feel free to contact us at any time to learn more about Bu contamination, how to control it within your manufacturing environment or to establish a testing program that is specifically designed to suit your needs.
Services Provided by CPTSM Labs
The Microbiology Department at CPTSM Labs performs all the Antimicrobial Preservative Effectiveness testing indicated above. Many more microbiological testing services are also provided, and a full list may be found at www.cptclabs.com.
In addition to Antimicrobial Preservative Effectiveness testing, other supporting departments are available at CPTSM to provide the ultimate in product support.
- Clinical. Conducting an HRIPT test, the Clinical Department will help to determine whether or not your product will be responsible for causing sensitization and/or irritation responses. Upon request, tests can be performed in order to support claims, such as “Dermatologist Tested”.
- In-Vitro Safety/Toxicology. Available to perform skin-irritation tests, ocular-irritation tests, skin-corrosion tests, etc.
- Photobiology. When a product is applied topically, it is important to understand how molecules will change when exposed to UV light. This is ideal when aiming to tests the phototoxic and photo-allergic reaction potential of a product.
- Analytical. From stability shelf-life testing to low-level impurities, detecting claims, before a product is launched, the Analytical department ensures that all requirements are met, based on industry and regulatory standards.
- Consulting. The staff at CPTSM can perform GMP and GLP audits of a client’s facilities and/or vendors’ operations We are also available to help create SOPs, develop Raw Material testing programs, as well as provide guidance as to which testing methodologies are best for developing meaningful claim support tests