ARTICLES BY CRYSTAL M. BOOTH

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

  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

  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

  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

  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?

  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

  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

  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

  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

  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

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

• Microbial Expectations For 503B Compounding Pharmacies

  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.

• Designing An Environmental Monitoring Program For Non-Sterile Manufacturing: A Risk-Based Approach

   the regulations governing non-sterile manufacturing are not as clear or as abundant as those for sterile manufacturing. This leads many manufacturers to utilize risk assessment analysis tools to adapt portions of sterile manufacturing guidelines when developing environmental monitoring programs for non-sterile environments.

• An Introduction To Environmental Monitoring & Cleaning For Aseptic Environments

  Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. This article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning in cleanrooms.

• How To Establish An Aseptic Gowning Qualification Program

  Humans are the primary source of contamination in cleanrooms. They are critical to the microbial regulation of the cleanroom and must be properly gowned. The primary purpose of cleanroom gowning is to protect the product and environment from contamination. When used correctly, cleanroom gowning greatly reduces the microorganisms released by personnel.

• The Basics Of Cleanroom Design & Material Transfer For Microbial Control

  In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects.