An overview of the validation and qualification requirements introduced in the 2022 EU GMP Annex 1 revision, with a focus on ...

Potency assay development uses DoE and QbD to improve accuracy, consistency, and regulatory readiness in biologics testing.

Expert insights on QMSR compliance: transition steps, gap assessments, risk-based approach, and global harmonization with ISO ...

Tank cleaning in specialty chemical manufacturing isn’t just routine maintenance. It directly affects product quality, ...

Data Security Standard (DSS), issued by the PCI Security Standards Council (SSC), which establishes technical and operational ...

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...

Taxing authorities’ use of these new tools and capabilities requires corresponding adoption by tax professionals.

Automated clean-in-place (CIP) systems sanitize the internal surfaces of process equipment without disassembly. By ...

Bench-scale results demonstrate HCT reduced wax content and produced stable, lighter crude-extending a proven platform from ...

Aduro Clean Technologies Inc . (“Aduro ” or the “Company ”) (Nasdaq: ADUR ) (CSE: ACT ) (FSE: 9D5 ), a clean technology ...

In highly regulated industries such as pharmaceuticals and biotechnology, manufacturing is about much more than producing a product. Companies must prove through clear documentation and testing that ...

Beverage processors are running CIP rinses too long — and paying for it in lost production time. Ecolab® Precise Wash, a module within CIP IQ™, uses advanced sensors to track soil removal in real time ...