Search results for " guidance"
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Vaccine Development and Production Challenges Manufacturers
A Committee report (2) recommended that FDA issue guidance for manufacturers on developing new vaccine assays and adjuvants and supported efforts to devise a “universal” flu vaccine. Committee members…
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The Bullish Outlook for Biosimilars
While not formalized yet, preliminary guidance suggests that this pathway will require the comparison of a biosimilar molecule to a single reference product. Similar to other markets, head-to-head com…
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Technologies and Practices Must Evolve to Meet Demand
Barriers to implementation remain; almost half of the respondents cited a lack of knowledge or training; 39% noted a lack of clarity on regulatory guidance; more than 25% noted a lack of management bu…
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Securing the Single-Use Supply Chain
Many of the industry-wide initiatives already underway to provide standardization and guidance on change notification, leachable/extractable testing, and other end-user needs for increased adoption of…
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Improving PAT for Biologics
The software permits early detection of process deviations and provides user guidance for identifying potential root causes of these deviations by displaying easy-to-understand graphics, resulting in …
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Application of Quality by Design to Viral Safety
ICH Q5A, Note for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Animal Origin, describes how the level of viral contami…
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Applying GMPs to the BioPharma Supply Chain
End users need to be equally open and clear to ensure that suppliers can provide their guidance as to the effective use of the raw material.
Effective (root cause) investigation approaches and too…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
This is also consistent with guidance from regulators, who encourage firms to view attributes as lying along a “continuum of criticality,” in which attributes warrant different degrees of control depe…
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FDA and EMA Extend QbD Parallel-Assessment Pilot Program
The agencies have agreed that there are further QbD areas that warrant additional inter-agency harmonization and expect to publish more guidance documents in 2014.
The program is open to applicatio…
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Early Communication with Regulators is Essential for SMEs
In the UK, an Innovation Office, opened in March by the country’s Medicines and Healthcare Products Regulatory Agency (MHRA), is providing multi-disciplinary guidance on “novel development methodologi…