Extending QMS to Contract Partners
Advances in cloud-based IT and user interfaces make it easier to collaborate, but a strong foundation, based on knowledge of data and risk management principles, is needed first.
Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization
The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.
Investigation Effectiveness Drives Human Performance Excellence
Are investigations supporting or hindering performance excellence?
Is Global Regulatory Gridlock Slowing Modernization?
PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.
Paperless Batch Records for the Masses
In InstantGMP, cloud-based IT and an approach grounded in cGMPs, brings more of the power of paperless recordkeeping to manufacturers, at a fraction of the cost.
Could Greater Transparency Improve Pharmaceutical Quality and Compliance?
Could greater market transparency improve pharmaceutical quality and regulatory compliance?
Ensuring Quality in Pharmaceutical Raw Materials
Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing models.
