• 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. 


  • Demystifying Performance Testing: Strategies To Qualify Combination Products

    Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first.

  • Introduction To Mass Transfer In Single-Use Bioreactors

    Mass transfer in single-use bioreactors is complex and often misunderstood, yet critical to the growth of cells in culture, This paper aims to elucidate the standard mass transfer model.

  • Innovative Strategies To Maintain Product Integrity In Biologic & Biosimilar Clinical Studies

    Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies which will almost certainly require cold chain handling.

  • Successful Techniques For Progressing Biotherapeutic Candidates From Late Discovery To The Clinic

    The reality is that many initially promising biotherapeutic candidates never make it to commercialization. It is estimated that only 1 in 1000 preclinical candidates reach the commercial market. Why does this happen? There are many that fail due to lack of efficacy or safety, but there are also candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. In our latest white paper, we help you to prepare for a successful transition to bring your drug candidate from discovery to the clinic.

  • Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy

    Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

  • LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance

    Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.




This e-book is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. It is intended to aid the practitioner avoid regulatory compliance issues. To that end, each technique provides the context for its application, formula(s), variables, and a fully worked example to help understand and apply the technique. Additionally, each technique demonstrates the linkage to risk to help demonstrate “a high degree of assurance.”

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