Quality Support
All ARx associates demonstrate a strong commitment to quality.
The ARx quality management team is comprised of pharmaceutical industry specialists dedicated to ensuring compliance with the relevant monographs, guidances, regulations, and adherence to the current Good Manufacturing Practices (cGMP). All ARx products are approved by regulatory authorities. Product safety, efficacy, and quality are assured at the ARx manufacturing facilities and all supply chain partners during each step of the development and commercial process.
The ARx quality team establishes true partnerships with our partners with open communication, product impact assessments and process improvements. ARx Quality strives to be an extension of our partner’s quality systems to ensure the best product available to patients. We support development and commercial partnerships by providing oversight of quality control, assurance of documentation completeness and accuracy, as well as certifications for global filings. Commercial manufacturing has ongoing monitoring of GMP processes to assure a continuous state-of-control. Our quality department includes supplier quality engineers, quality assurance, and quality control with finished product test & release.
Quality Support Capabilities
- FDA Registered and cGMP Compliant Facilities: ARx facilities have been audited and site approved by the FDA and other global agencies.
- Raw Material Support Packages: Establishment of specifications and certifications according to global compendial requirements.
- Supplier Quality Management: Assured at each level of the supply chain through supplier assessments and auditing.
- Product Release and Certification: Test and release of bulk intermediate and finished product.
Analytical Testing
Accelerate results with a dedicated analytical team
The ARx analytical team is dedicated to understanding and characterizing our transdermal and thin film products and dosage forms. ARx implements extensive product characterization activities for active pharmaceutical ingredients (APIs), excipients, reference listed drugs, and development prototypes to achieve a robust product formulation. By characterizing products and fundamentally understanding how each formulation ingredient contributes to the critical quality attributes, the ARx team increases the likelihood for success in clinical trials and product submissions, responding quickly to partner timelines and needs with onsite analysis.
With our own R&D and QC analytical labs onsite, ARx provides each sample with individualized attention and care. Our method development, validation, and release testing capabilities allow us to be a single source partner with quick turn-around times for critical decision-making upon results. At the ARx quality control Laboratory, each product is set-up in a Laboratory Information Management System (LIMS) to enable analysis in the laboratory with standardization, set-up and control of every sample. By only testing ARx developed products, we can adapt to partner timelines and priorities.
Analytical Testing Capabilities
- Physical Test Methods: Developed specific to each product to understand the behavior of our films and patches.
- Excipient and Raw Material Release Testing: Following USP or partner specific methods.
- Broad Range of In-Process and Finished Product Release Testing: Utilizing HPLC, GC for Assay, Impurities, Content Uniformity, Dissolution, Residual Solvent, etc.
- Stability Study Management: Ensuring quick turnaround times, ARx tests, analyzes and reports results for quick progression of programs.
- Plus many more capabilities for chemical analysis, drug compatibility testing, and environmental monitoring.
