ARTICLES BY CRYSTAL M. BOOTH

• Cleanroom Gowning Programs Compliant With EU GMP Annex 1

  12/15/2022

  Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.

• Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview

  12/1/2022

  This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.

• The Essential Components Of A Sterility Assurance Program

  10/15/2021

  The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.

• Tools And Best Practices For Trending Environmental Monitoring Data

  4/11/2021

  Environmental monitoring (EM) trending is an essential component of the EM program to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure establishment of an efficient environmental monitoring program.

• An Introduction To Trending In Environmental Monitoring Programs

  4/5/2021

  Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM. 

• A Quality Agreement Primer: What To Include & Who To Assign It To

  10/16/2020

  Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.

• A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity

  10/9/2020

  This is part two of a three-part article on quality agreements. Part one discussed identifying key risks in partnering with contract companies and working with vendors. This second part explores the regulations and enforcement activities that apply to quality agreements.

• A Quality Agreement Primer: Managing Risk When Working With Contractors

  10/2/2020

  This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.

• Applying Aseptic Practices To Protect Yourself From COVID-19

  4/20/2020

  During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.

• Environmental Isolates: What’s The Proper Use Of In-House Cultures?

  6/24/2019

  Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity. This article discusses the current regulations andguidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.

• 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.

• In-Process Bioburden Testing Of Pharmaceuticals: The Story Behind The Data

  6/4/2018

  This article looks at in-process bioburden testing and the importance of establishing accurate data and routinely monitoring the data for adverse trends.