PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.
News|Articles|June 6, 2017
Mikart Announces Compliance with DSCSA Serialization Requirement
Author(s)Pharmaceutical Technology Editors
The company announced that it is fully compliant with the 2017–2023 serialization and aggregation requirements.
Advertisement
On June 5, 2017, Mikart announced that it is fully compliant with 2017–2023 serialization and aggregation requirements in the Drug Supply Chain Security Act. The Atlanta-based company has partnered with Optel Vision, which makes hardware and software that generates, reads, applies, and verifies codes throughout the entire packaging process, and TraceLink, the data warehouse that makes information contained in the serialization codes available to every point in the pharmaceutical supply chain.
Mikart offers a full range of services in addition to serialization and aggregation, including pharmaceutical development, clinical trial manufacturing and packaging, regulatory submissions, commercial scale manufacturing, and packaging solutions.
Source: Mikart
Advertisement
Related to this article
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Advertisement
Advertisement