Quality leads every step of the way.

As an FDA-registered 503B outsourcing partner, STAQ Pharma adheres to current Good Manufacturing Practices (cGMP) requirements outlined by the Food and Drug Administration (FDA). Our dedicated Quality Unit created, successfully implemented, and continuously monitors the STAQ Pharma Quality Management System (QMS) for both locations.

STAQ Pharma’s QMS consists of Standard Operating Procedures (SOP), Work Instructions (WI), and specifications executed through our Master Control System.

Our Quality-led Processes

We adhere to an “Everyone Is Quality” mentality to ensure that the utmost expertise and accuracy is applied to all STAQ Pharma processes.

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Product Development

In STAQ Pharma’s product development phase, we focus on innovation and safety. During this stage, we use extensive research and development to formulate our products with precision, ensuring every product meets rigorous standards and addresses critical market needs

Quality Oversight

-New Product Development
-Validation

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Production

During our production phase, STAQ Pharma’s expertise in pharmaceutical compounding is exemplified. Each step in our production process—from kitting to formulation to fill—is performed under strictly controlled conditions, complying with all regulatory standards to ensure that every batch is consistent, effective, and safe.

Quality Oversight

-Training
-Document Management
-Maintenance & Calibration
-Environmental Monitoring
-Deviations & Investigations
-Change Management

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Quarantine Period

After production, our products enter a Quarantine Period to allow for thorough quality control testing. Once our testing is complete and successful, the batch then undergoes labeling and packaging, followed by release. Each batch is released with a Certificate of Analysis (CoA).

Quality Oversight

-Quality Assurance (QA) Release

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Shipping & Customer Sustainment

All shipments are tracked once they leave our facilities. We continue to support the product and our customers post-delivery with a dedicated account manager and customer service team. Our continuous evaluations to improve our products and services ensure we are always meeting the needs of our customers.

Quality Oversight

-Quality Assurance (QA) Release

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Sourcing from Approved Suppliers

STAQ Pharma maintains rigorous standards when approving our suppliers. All of our suppliers are selected based on a stringent evaluation process that assesses their reliability, safety, and compliance with our requirements to provide us with high-quality materials and pharmaceutical ingredients. Upon receipt, our team assesses the material packaging integrity and places it into quarantine. Raw materials are released after the quality control department determines that the materials meet internal specifications and/or also pass relevant test results prior to use in manufacturing.

Quality Oversight

-Supplier Quality Management
-Raw Materials Quarantine, Testing, and Release