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December 02, 2016
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.
Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.
Pharmaceutical companies must see regulators as partners in their efforts to provide safe and effective therapies worldwide.
November 28, 2016
FDA has revised its draft guidance to provide greater clarity and focus. This version would establish an initial voluntary phase to allow regulators and industry to focus, first, on a limited set of metrics.
FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations
Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor
November 17, 2016
At ICH’s November 2016 meeting, the council announced new members and new guidelines.
The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.
November 15, 2016
The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.
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