Regulatory/GMP Compliance

Aug 02, 2018
Pharmaceutical Technology
The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
Aug 02, 2018
Pharmaceutical Technology
More consistent and reliable production processes are critical for advancing innovative treatments.
Aug 01, 2018
Pharmaceutical Technology
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
Aug 01, 2018
Pharmaceutical Technology's In the Lab eNewsletter
Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.
Jul 27, 2018
By Pharmaceutical Technology Editors
The recommended drugs include two orphan medicines and three biosimilars.
Jul 25, 2018
Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.
Jul 19, 2018
By Pharmaceutical Technology Editors
FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
Jul 19, 2018
By Pharmaceutical Technology Editors
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
Jul 19, 2018
By Pharmaceutical Technology Editors
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Jul 19, 2018
By Pharmaceutical Technology Editors
The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.
native1_300x100
lorem ipsum