Articles by Crystal M. Booth
-
Risk Assessment Of Objectionable Microorganisms In Nonsterile Pharmaceuticals
4/19/2019
This is Part 2 of a two-part article on objectionable microorganisms in the nonsterile microbiology industry It discusses a risk-based approach to determine if a microorganism is objectionable for an application.
-
Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals
4/5/2019
This article explains what an objectionable microorganism is and explores the regulatory expectations for objectionable microorganisms in nonsterile products.
-
How To Establish Growth Promotion Tests For Pharmaceutical Culture Media
1/7/2019
The article discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.
-
Should You Rotate Disinfectants? Industry Experts Weigh In
9/14/2018
Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. This article discusses the concept of disinfectant rotation and the current mainstream industry practices.
-
Microbial Expectations For 503B Compounding Pharmacies
1/22/2018
According to section 503B of the Food Drug and Cosmetic Act, outsourcing facilities are required to comply with all cGMPs and regulations regarding insanitary conditions. Many regulatory observations are written for the failure to follow cGMPs and insanitary conditions. This article highlights some of the microbial expectations for 503B compounding pharmacies.
-
Cleanroom Microbiology 101: Identify And Control Sources Of Contamination
5/26/2017
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood.
-
5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 2)
3/22/2017
This article explains the final three components that can be used to establish a compliant disinfectant efficacy testing package in the U.S. along with tips for assembling the package.
-
5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)
2/21/2017
There are many regulations and guidance documents that discuss disinfectant efficacy testing, and establishing a compliant disinfectant efficacy testing package aids in providing clear documentation that the disinfectants employed in a facility have been analyzed as required by these regulations.