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March 02, 2016
Siegfried Schmitt, principal consultant, PAREXEL, discusses how the regulatory requirements for CGMPs is the different phases of drug development and manufacture.
Data integrity is a widespread, global problem that must be addressed.
Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.
February 18, 2016
Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.
The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.
February 12, 2016
Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.
February 03, 2016
The author reviews FDA's final Animal Rule guidance.
February 02, 2016
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.
Choosing the right excipient manufacturer can help ensure the use of quality excipients.
February 01, 2016
Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.