Search results for " guidance"
Article
Biosimilar Quality Requirements
In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…
Article
Regulatory Challenges in the QbD Paradigm
FDA has addressed this gap to some extent through its ongoing QbD pilot program, but more guidance is needed from the regulatory authorities to ensure widespread successful implementation of QbD (2). …
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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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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Topics covered include:
1:33 – Key regulatory guidelines for biopharma companies to follow
3:00 - Recent guidance changes/additions that impact biopharma
3:37 - Areas where additiona…
Article
Best Practices in Qualification of Single-Use Systems
66, Application of Single-Use Systems in Pharmaceutical Manufacturing, has been developed to provide comprehensive, high-level guidance about qualification of SUS (1). This paper focuses on technical …
Article
Good Manufacturing Practices: Challenges with Compliance
For example, it is straightforward to complete gap assessments and ensure procedures align with the various laws, guidances, and technical publications that make up current CGMPs.
However, the s…
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The Importance of Partnering for Bioanalytical Studies
FDA has issued guidance documents detailing the scope of bioanalytical method validation required for PK/PD endpoints, but it is also important to consider other regional guidance documents (e.g., Eur…
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Understanding Validation and Technical Transfer, Part I
Subsequent revisions to US and international regulations and guidance documents stressed the need for process validation and quality management systems to ensure pharmaceuticals and biopharmaceuticals…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…