Search results for " CGMP"
Article
Raw Material Variability
Aligning supplier capabilities to end user and regulatory requirements will increasingly necessitate ‘pharma standard’ attitudes and cGMP operations for second- and third-tier suppliers, whereas only …
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
It’s true that these regions have yet to provide the institutional knowledge, facilities, and quality systems to compete in terms of commercial cGMP manufacturing infrastructure, and they have yet to …
Article
Implementing QbD in Sterile Manufacturing
We primarily execute a design review within the construction phase for each cGMP relevant piece of major process equipment. An example element of this design review is conducting mock-up studies.
…
Article
Bioprocessing Advances in Vaccine Manufacture
Even easier than with SUS process lines, modular systems allow whole plants to be essentially cloned, potentially allowing cGMP manufacture in many developing countries. Many foreign countries are and…
Article
FDA Seeks Metrics to Define Drug Quality
FDA is seeking new strategies to spur compliance with GMPs and to limit drug production errors that lead to supply problems, Woodcock explained at a July 10, 2013 seminar on “Understanding cGMPs” spon…
Article
Operational Excellence: More Than Just Process Improvement
…and provide guidance to help up-skill shop floor personnel in their understanding and performance of cGMP/compliance.
To tackle human-error-caused deviations, the deviation management process was…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
BioPharm: Regarding imports, FDASIA notes that foreign manufacturers must demonstrate the regulatory status of their drug as well as cGMP compliance and prove facility registration within the US; othe…
Article
Quality by design for biotechnology products—part 1
Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda, MD; 2006.
4. US FDA. Guidance for industry: PAT—A framework for innovative pharmaceutical developm…