RAPS

FDA reprimands two firms for missing validation programs, poor facility maintenance

Inadequate validation of manufacturing processes, failure to conduct microbiological testing of drugs and keeping a facility in a poor state of repair, prompted the US Food and Drug Administration ...
RAPS

FDA warns drug, device makers for CGMP violations

The US Food and Drug Administration (FDA) has issued warning letters to several drug and device manufacturers for failing to meet its current good manufacturing practices (CGMP). Among the violations, ...

Bioprocess Validation Market to Value USD 1.25 Billion by 2035, Expanding at a 9.25% CAGR – SNS Insider

U.S. Bioprocess Validation Market Projected to Reach USD 285.96 Million by 2032, While Europe Market to Hit USD 347.6 Million by 2035 Amid Rising Demand for Biologics, Biosimilars, and Single-Use ...
Business Wire

Tivic Health Enters GMP Manufacturing Validation Agreement with Scorpius BioManufacturing in Preparation for FDA Submission

FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...