Quality Assurance (QA) Methodology

Drugs are only as pure as the sources they are manufactured from.

But achieving consistently high quality without incurring costly overhead expenses can be a tricky endeavor. For this reason, ADRANTZ has developed a multi-faceted approach based on the Six Sigma Methodology, a management philosophy developed by Motorola that emphasizes setting strong objectives, collecting data, and analyzing results to enhance business operations. By following this methodology, we can provide high quality active pharmaceutical ingredients (API’s) to our customers in a timely manner.

We know that our customers demand the highest quality ingredients at all times, but we also understand that our customers come to us to ensure they consistently receive the raw materials they need in a reasonable timeframe. Further, we understand that in the event of an audit, our customers may require specific information about any given product or order, to ensure we can meet this need, ADRANTZ has developed a comprehensive healthcare compliance program. Leveraging ADRANTZ own 3DS™ technology, customers have a self service center to answer any questions and access all documentation related to every transaction performed with ADRANTZ.

Utilizing the Six Sigma Methodology, ADRANTZ has developed a step-wise process to ensure the quality of product supplied by each of its manufacturers.The components of our approach address three critical delivery areas:

a. Quality and Consistency
b. Availability and Timeliness
c. Healthcare Compliance

Quality and Consistency

We first review and all relevant documentation to ensure it is filed properly with the appropriate agencies. We then verify the integrity of the documentation by discretionarily testing product samples to ensure that each product meets our customer’s demands for quality.

Availability and Timeliness

Once we are confident in our supplier’s ability to provide quality products, we then focus on ensuring that each supplier can provide the products our customers need in the timeframe which they require. We work closely with each supplier to ensure that we are made aware of their inventories well in advance of our customer’s demands. This allows us to remain flexible when giving quotes and gives our customers piece of mind when it comes to ordering raw materials quickly.

Healthcare Compliance

Our comprehensive compliance program ensures that ADRANTZ and its customers stay ahead of the inspections and audit curve by providing an actionable framework and process-oriented toolkit which tracks even the most minute of details.

Our compliance program consists of seven competency areas:

a. Written Standards
     i. Code of Ethics
     ii. HHS-OIG Guidance
b. Leadership & Structure
     i. Compliance Officers
     ii. Compliance Committee
c. Education & Training
d. Internal Lines of Communications
e. Auditing & Monitoring
f. Responding to Past & Potential Violations
g. Corrective Action Procedures