Consistent Quality. GMP Principles. Certified Commitment.
At SpecializedRx, quality is more than a requirement — it’s the foundation of everything we do. We are committed to delivering products that support the safety, consistency, and regulatory compliance of pharmaceutical and biopharmaceutical products.
We focus on:
- Maintaining robust cGMP-aligned systems
- Continuously improving processes through data, feedback, and audits
- Educating and training our expanding team on current quality practices
- Challenging our systems regularly to meet or exceed industry expectations
Our Quality Management System (QMS) is supported by third-party certification (ANAB) and designed to ensure every product meets applicable FDA and global quality standards. Whether it’s raw material control, production monitoring, or final release, our quality controls are designed for transparency, traceability, and compliance.
Certified to ISO 22716
SpecializedRx ISO Certification – View Certificate PDF
SpecializedRx holds ISO 22716 certification, a globally recognized guideline that
provides a practical framework for applying current Good Manufacturing Practices (cGMP). While traditionally focused on cosmetics, this standard outlines essential cGMP principles that apply broadly across regulated industries, including:
- Qualified personnel and clean premises
- Equipment maintenance and material control
- Documented production and quality control procedures
- Storage, shipment, and traceability of finished products
Our certification reflects our commitment to operating with discipline, cleanliness, documentation, and consistency — cornerstones of any effective cGMP system.
Continuing Our Quality Assurance Journey
As part of our continuous improvement strategy, SpecializedRx is actively aligning with additional cGMP framework, such as:
- IPEC-PQG Good Manufacturing Practices for Pharmaceutical Excipients
- FDA 21 CFR Parts 210/211
SpecializedRx is also focused on furthering our certifications pursuant to ISO 9001 and EXCiPACT™ certifications.
We are dedicated to expanding our certifications and to further strengthen our Quality System. Please check back here for the latest updates on our expanding certifications.
