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February 02, 2021
Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.
With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.
January 29, 2021
The company is recalling one lot of Cisatracurium Besylate Injection, USP 10mg per 5mL because of mislabeling.
January 11, 2021
The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.
January 02, 2021
Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.
EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.
Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.
December 31, 2020
FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.
Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.
December 15, 2020
The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.