Featured Bioprocessing Editorial
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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.
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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.
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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.
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Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?
2/10/2021
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.
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Certifying Exports: A Roadmap To EMA’s Certificate Of Medicinal Product
2/8/2021
In Part 1 of this series, we discussed requirements for exporting U.S.-manufactured material to foreign markets supported by an FDA-issued certificate of pharmaceutical product. Here in Part 2, we will explain how to export EU-manufactured product to foreign markets leveraging a certificate of medicinal product issued by the European Medicines Agency.
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Best Practices: Risk-Based Environmental Monitoring Of Biopharma Facilities
2/3/2021
While EM programs are one of the most effective tools in monitoring the state of control of classified manufacturing areas, designing an EM program is a relatively complex task. Facilities vary considerably and there is inadequate specific guidance on how to design EM programs and no single standard risk assessment methodology exists.
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Certifying Pharma Exports: Intro To FDA’s Certificate Of Pharmaceutical Product
2/1/2021
When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. In Part 1 of a two-part article, we discuss the requirements for exporting U.S.-manufactured material to foreign markets leveraging a certificate of pharmaceutical product (CPP) issued by the FDA.
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Quality Management Review — Benchmarking Quantitatively!
1/29/2021
Typically, when the cost of quality is depicted, it is split into “cost of control” and “cost of failure of control.” At the next level of detail, the costs of prevention and appraisal appear on one side and the costs of internal failure and external failure on the other side. How to interpret and implement these buckets at the tactical level is often left to personal imagination.
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What Role Will India Play In The Global COVID-19 Vaccine Narrative?
1/27/2021
While most Americans are focused on the incredible success of the COVID-19 vaccines developed and produced by Pfizer and Moderna under the $24 billion Operation Warp Speed, there is under-reported news from India that bears a closer look.
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When Biopharma Automation Projects Fail: Averting Disaster
1/25/2021
Automation does not always result in success, and poor automation can be as damaging to the pharmaceutical organization as no automation at all. This article addresses what happens when automation goes wrong and how mistakes can be avoided by adopting a risk-centric approach.