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August 22, 2019
Marchesini Group’s Compact 12 electronic counter with HarleNIR vision system measures product and active ingredient when filling and capping bottles for tablets and capsules.
August 21, 2019
FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.
August 16, 2019
FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
August 15, 2019
The company is recalling the product because of potential microbiological contamination.
August 14, 2019
Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.
August 12, 2019
Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and incorrect potency.
August 02, 2019
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.
Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.
To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.