Search results for " FDA"
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
From the US perspective, there's a bunch of different guidelines on the FDA’s website you can look for, and you can also look on the European Union's website as well.
Looking at various Interna…
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Assessing Manufacturing Process Robustness
In 2011, FDA’s revised process validation (PV) guidance (7) extended ICH’s concepts to the pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other area…
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Challenges in Analytical Method Development and Validation
Technologies, such as FDA’s quality-by-design (QbD) initiative, may have a positive impact on analytical method development and validation according to Paul Smith, EMEAI laboratory compliance producti…
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Good Manufacturing Practices: Challenges with Compliance
Obstacles to compliance
BioPharm: What challenges do you see in complying with FDA’s CGMP regulations for biopharmaceutical manufacturing?
Smith (Catalent): In general, it is not difficult t…
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The Importance of Partnering for Bioanalytical Studies
Bose (Emery Pharma): On a broader perspective, FDA requires PK, toxicokinetic, or biomarker concentration evaluation through bioanalytical studies. It is critical that the data [are]generated via phas…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Earlier this year, FDA issued a statement revealing that there are already more than 800 active cell-based or directly administered gene therapy investigational new drug applications (INDs) currently …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Along with the process lifecycle approach, other guides have been issued by FDA and the International Council for Harmonization (ICH), which include the concepts of quality by design (QbD), risk manag…
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Bioburden Control in the Biopharmaceutical Industry
Up-to-date lists of product recalls due to contamination by objectionable microorganisms are provided by FDA (1). The Center for Food Safety and Applied Nutrition (CFSAN)—under FDA—provided a comprehe…
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Efforts Accelerate to Streamline Postapproval Change Process
To spur the Q12 process, FDA in 2015 issued a draft guidance on defining and reporting ECs (2). The guidance describes which elements of a control strategy could be considered ECs necessary to assure …
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Aseptic Processing: Keeping it Safe
Aseptic processing has garnered some increased scrutiny from FDA in recent years, primarily because it is considered a high-risk activity by the agency, says Rainer Newman, consultant at Aseptic Proce…