Search results for " guidance"
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…
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FDA Seeks Metrics to Define Drug Quality
Despite a decade of encouragement and guidance from FDA, manufacturers have failed to adopt a “continuous improvement model,” according to Janet Woodcock, director of the Center for Drug Evaluation an…
Article
Operational Excellence: More Than Just Process Improvement
…ions staff, there to help assure quality and compliance, but also to help address issues and provide guidance to help up-skill shop floor personnel in their understanding and performance of cGMP/comp…
Article
Essentials in Establishing and Using Design Space
FDA, Guidance for Industry, Process Validation: General Principles
and Practices (2011).
3. S. Chatterjee, “Design Space Considerations,” FDA, AAPS Annual Meeting, October 14, 2012, Chicago, O…
Article
Elucidating Biosimilars Characterization
Quintiles: The amino-acid sequence of a biosimilar molecule is one of the starting points in determining similarity to the originator medicine, with the draft guidance from FDA implying that a biosimi…
Article
PDA's Technical Report for Biotech Cleaning Validation
The report provides a single-source overview for biotechnology manufacturers and complements existing guidance and reference documents. It builds on and updates previous PDA publications, including th…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
FDA, Guidance for Industry: Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies (Rockville, MD, April 1997).
42. G.T. Jennings and M.F. Bachmann, …