Contributing Editors

1. 11 Critical Steps To Manage Solvents During API Manufacturing 3/5/2021

   To reduce costs and provide flexibility, manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of active pharmaceutical ingredients (APIs) and associated intermediates. This presents a risk of cross-contamination that might not be detected when the solvent is tested before offloading into a manufacturing site distribution system. This article explores the risks and 11 mitigation options available to API manufacturers.

2. Integrating Excipients Into QbD For Drug Development: Understanding Drift & Critical Material Attributes 3/3/2021

   This article is the second in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). Learn about product, process, and excipient drift, as well as critical material attributes.

3. The “New Normal”: Changing Perceptions on Bioprocess Intensification and Continuous Bioprocessing 3/1/2021

   Process intensification and continuous bioprocessing are concepts without clear, consistent definitions. What may be included (or not) often varies greatly and, in some ways, has become more about aspirational goal-setting than actual innovation adoption. BioPlan Associates, Inc. has assessed the changing perspectives of 122 bioprocess decision-makers in this survey, now in its 18th year.

4. Important cGMP Considerations For Implementing Electronic Batch Records 2/26/2021

   Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met. 

5. Incorporating Excipients Into QbD Studies For Drug Development — An Introduction 2/24/2021

   This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variability on finished product quality and more!

6. FDA Steps Up Support For Advanced Manufacturing Technologies 2/22/2021

   In its latest move to encourage the broader adoption of advanced manufacturing technologies, the FDA has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) that combines the strength of FDA’s regulatory expertise and NIST’s globally recognized precision characterization and standards. The MOU is significant because it takes the next step in providing much-needed guidance and resources to the industry.

7. FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers 2/19/2021

   Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.

8. Developing Future Delivery Models For ATMPs: Practical Considerations 2/17/2021

   With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.

9. 7 Rules For Properly Interpreting Control Charts 2/15/2021

   It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. 

10. 9 Rules For Cleaning Verification & Validation Of Multipurpose API Plants 2/12/2021

    Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an active pharmaceutical ingredient (API) plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.