Quality & Compliance

USP <797>

Sterile compounding practices with environmental monitoring, sterility (USP <71>) and endotoxin testing (USP <85>), beyond‑use dating, and documented workflows.

USP <795>

Non‑sterile compounding procedures, Master Compounding Records/Compounding Records (MCR/CR), validated scales/equipment, and traceable lots.

USP <800>

Hazardous drug handling controls integrated into training, PPE, storage, spill, and waste procedures where applicable.

QA/QC Practices

• Documented SOPs with version control and periodic review.
• Incoming raw material qualification and COA verification.
• In‑process checks: weight/volume verification, pH/osmolarity (as applicable).
• Finished product checks: appearance, labeling, and documentation completeness.
• Release by authorized personnel after review of records and tests.

Environmental Monitoring

• Viable and non‑viable monitoring at defined frequencies (ISO‑classified areas).
• Differential pressure, temperature, and humidity logs.
• Cleaning/disinfection schedules with approved agents.
• Action/alert levels with documented investigations.

Labeling & Traceability

• Serialized labels with product name, strength, lot, BUD, storage conditions, and cautionary statements.
• Lot‑level records linking raw materials to finished batches.
• Documentation package available to verified providers (on request).

Shipping & Cold‑Chain

• Insulated packaging and gel packs/ice as needed based on stability.
• Shipment scheduling to avoid weekend delays; expedited options available.
• Tracking and delivery confirmation for controlled/temperature‑sensitive items.

Change Control

We manage procedural, formulation, equipment, and supplier changes through a documented review/approval process with risk assessments and training.

Deviations & CAPA

Events are investigated to root cause with corrective and preventive actions tracked to closure.

Provider Documentation

• Batch COAs and testing summaries (as applicable).
• Certificates for raw materials and excipients.
• Storage/handling guidance and SDS where relevant.

Available to verified providers upon request.

Training & Qualification

• Personnel training records and qualification procedures.
• Gowning and aseptic technique qualifications for sterile areas.
• Equipment calibration and maintenance logs.