With over a decade of cGMP-compliant operations, Pine is committed to meeting the FDA’s stringent guidelines.
100%
Our uncompromising commitment to quality means we ensure nothing less than 100%.
Quality at every step
Every product that leaves our FDA-registered 503B facility is manufactured following a strictly controlled process, after which rigorous protocols are followed. With quality as our central focus at every step, raw materials are transformed into superior pharmaceutical compounds you can count on.
Pre-Production
Training
All compounders undergo comprehensive hands-on training and aseptic process qualifications before preparing sterile drug products for patient use.
Compounders are routinely evaluated and monitored for compliance with Standard Operating Procedures (SOPs).
Supplier/Material Qualification
All materials are sourced through qualified suppliers and subjected to incoming quality control evaluation.
Quality control testing is utilized to ensure conformance of raw materials (e.g., appearance, identification, bioburden, sterility, and pyrogen testing).
Production
Preparation
All preparation occurs in controlled classified areas as required by cGMP and Guidance for Industry.
Compounding
All sterile compounds are prepared within ISO 5 environments, utilizing the latest manufacturing technology and automation.
Monitoring
All cleanroom facilities are certified semi-annually and monitored 24/7 to ensure proper operation and cleanroom integrity.
Post-Production
Inspection
Sterile compounds must conform to a set specification for visual inspection, including visible particulate limit.
Batch Release Testing
All finished drugs are tested in accordance with individual product specifications to ensure conformance for release.
Distribution
Certificate of Analysis (CoA)
Once release testing results have satisfied our requirements, a CoA is issued, ensuring your order has met the highest quality standards.
Shipping
Orders are shipped via qualified shipping containers to ensure product integrity.
Quality in the materials that we bring in.
Quality in the processing that we do.
Quality in our release and in our distribution.
Gayle Gleason
Director of Quality
Quality in the materials that we bring in. Quality in the processing that we do. Quality in our release and in our distribution.
Gayle Gleason
Director of Quality
See quality in action
Schedule a facility tour today
Schedule a virtual tour or visit Pine Pharmaceuticals for an in-depth look into our state-of-the-art processes and industry-leading innovations.
Explore our product portfolio
Our extensive portfolio of ready-to-administer and ready-to-use drug products offers extended dating and non-patient-specific ordering, enabling your practice to always have inventory on hand and ready to go.
State-of-the-art facility
Our new 75,000-square-foot facility gives us the agility to address drug supply issues quickly and the flexibility to adapt as needs change.
Learn more
A tradition of excellence
As one of the few independently owned and operated facilities in the industry, we answer only to our customers. Our focus is simple: delivering affordable, reliable, and high-quality drug products our customers can trust.
