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Quality

With over a decade of cGMP-compliant operations, Pine is committed to meeting the FDA’s stringent guidelines.

Contact UsOur Process

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

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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).

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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

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Preparation

All preparation occurs in controlled classified areas as required by cGMP and Guidance for Industry.

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Compounding

All sterile compounds are prepared within ISO 5 environments, utilizing the latest manufacturing technology and automation.

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Monitoring

All cleanroom facilities are certified semi-annually and monitored 24/7 to ensure proper operation and cleanroom integrity.

Post-Production

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Inspection

Sterile compounds must conform to a set specification for visual inspection, including visible particulate limit.

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Batch Release Testing

All finished drugs are tested in accordance with individual product specifications to ensure conformance for release.

Distribution

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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.

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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

Pine IV bags | 503B IV bag products | Pine Pharmaceuticals

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

Pine IV bags | 503B IV bag products | Pine Pharmaceuticals

See quality in action

Quality testing chemistry | Pine Pharmaceuticals
Quality Ophthalmology products | 503B | Pine Pharmaceuticals
Quality control testing | 503B Outsourcing | Pine Pharmaceuticals

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.

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Explore our product portfolio

Explore product portfolio | Pine Pharmaceuticals

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.

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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.

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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.

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503B Outsourcing Facility | Pine Pharmaceuticals

Quality compounds prepared by a quality partner.

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