Regulatory/GMP Compliance

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.
Jul 18, 2018
By Pharmaceutical Technology Editors
Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.
Jul 10, 2018
By Pharmaceutical Technology Editors
Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.
Jul 03, 2018
By Pharmaceutical Technology Editors
The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
Jul 02, 2018
Pharmaceutical Technology
Vendors are offering template-based models and direct data-filing services to help smaller companies meet imminent deadlines.
Jul 02, 2018
Pharmaceutical Technology
Maintaining good quality control practices throughout the entire manufacturing process requires robust development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.
Jul 02, 2018
Pharmaceutical Technology
Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.
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