Quality Control in Compounding Pharmacy That Delivers
At OutSourceWoRx , Quality Control isn’t just a function it’s our foundation. As a state-of-the-art 503B outsourcing facility, we deliver sterile, ready-to-use medications with the precision, reliability, and oversight healthcare providers depend on.
We have one mission: to make sure every dose is compliant, consistent, and clinically trusted. We serve hospitals, clinics, and other medical facilities to do this.
Built on cGMP and Backed by Experts
Our facility is fully aligned with Current Good Manufacturing Practices (cGMP) and adheres strictly to USP <797> standards. We apply rigorous quality oversight to every aspect of our compounding process, from raw material sourcing to batch release.
Our team of expert pharmacists and specialists has decades of experience in sterile compounding. This ensures every product meets the highest safety, potency, and sterility standards for healthcare.
We don’t just meet industry standards, we exceed them.
Our Quality Control Process
We take a multi-layered approach to Quality Control in Compounding Pharmacy. This means we combine internal audits, environmental monitoring, and third-party checks to ensure absolute safety and compliance.
Key Quality Assurance Measures:
Verified, tested, and traceable from certified and trusted suppliers.
Real-time environmental and personnel monitoring
Sterility, potency, stability, and endotoxin testing
Independent verification of product integrity
Certificates of Analysis (CoA), batch records, and release reports
For temperature-sensitive medications
Batch Release Integrity: No Compromise
Every compounded medication we deliver undergoes a rigorous batch release protocol, which includes:
- In-process quality checkpoints
- Documentation verification
- Test result review
- Final sign-off by QA leadership
- Third-party testing for applicable products
We approve a shipment only after a product has met every standard. This guarantees our clients get medications that are safe, stable, and fully compliant.
Transparency & Documentation
We believe that trust starts with transparency. That’s why every client receives:
- Certificates of Analysis (CoAs)
- Batch-specific testing results
- Expiration dating and storage guidelines
- Full traceability of ingredients and compounding history
We maintain digital records for audits and traceability. This makes it easy to integrate our quality systems into your hospital or clinic’s compliance protocols.
Backed by Clinical Intelligence
Our quality systems are not only technical, they’re informed by real-world clinical experience. Our pharmacists understand the therapeutic impact of every formulation, allowing us to design protocols that align with:
- Patient safety
- Hospital workflow
- Treatment protocols
- Specialty care requirements
This insight makes us a trusted partner for all areas of care, from inpatient settings to outpatient clinics.