GUEST COLUMNISTS

• FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers

  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.

• Developing Future Delivery Models For ATMPs: Practical Considerations

  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.

• 7 Rules For Properly Interpreting Control Charts

  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. 

• Cleaning Verification & Validation Of Multipurpose API Plants: 9 Rules To Follow

  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.

• Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?

  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.

• Certifying Pharmaceutical Exports: A Roadmap To EMA’s Certificate Of Medicinal Product

  In Part 1 of this two-part series, we discussed requirements for exporting U.S.-manufactured material to foreign markets supported by an FDA-issued certificate of pharmaceutical product (CPP). Here in Part 2, we will explain how to export EU-manufactured product to foreign markets leveraging a certificate of medicinal product (CMP) issued by the European Medicines Agency (EMA).

• Establishing Best Practices For Risk-Based Environmental Monitoring Of Modern Drug Product Facilities

  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.

• Certifying Pharma Exports: Intro To FDA’s Certificate Of Pharmaceutical Product

  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.