Search results for " guidance" in Articles / App Notes
Article
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…
Article
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 …
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
2014 Manufacturing Trends and Outlook
Reasons cited for not implementing QbD include a lack of guidance and direction from regulatory agencies (46.2%), no process or quality advantage to be gained (30.8%), a lack of understanding of the Q…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
State of Quality and Compliance in the Biopharmaceutical Industry
The quality unit is needed to help assure the proper systems are in place, monitor those systems, and provide guidance when needed. To do this effectively, quality needs to have a presence on the shop…