What We Do

Sterile and Nonsterile Compounding Practice Evaluation
Clinical evaluation of 503A compounding practice against USP standards and professional best practicesEducation and Staff Training
Aseptic technique, workflows, and documentation principles that support consistent practiceFormulation Development and Optimization
Evaluation of formulation design, critical components, and stability and analytical data to guide formulation selection and beyond-use dating

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Why Choose Us

Integrity-Driven Consulting
Transparent, accountable guidance focused on long-term quality, not box-checkingExpert, Practical Guidance
Recommendations grounded in pharmaceutical science, USP standards, and real-world pharmacy operationsRisk-Based, Proportionate Solutions
Recommendations prioritize patient safety and the intent of USP standards while accounting for operational and resource realities in 503A pharmacy settings

Baseline Practice Assessment

Structured review of current practices to identify gaps relative to USP standards and professional best practices, with prioritization based on risk and feasibilityCommon Deliverables:
• Facility and workflow review
• Assessment of SOPs, records, and training documentation
• Risk-ranked findings with recommended corrective actions
• Summary suitable for owners and pharmacy leadership

SOP, Documentation, and Training System Development

Development or refinement of SOPs and associated records designed to support consistent execution and staff trainingCommon Deliverables:
• SOPs aligned to actual sterile and nonsterile workflows and decision points
• Procedures structured as day-to-day training and reference tools, not solely recordkeeping documents
• Forms and logs that reinforce procedural requirements and staff accountability
• Document control structure (versioning, approvals, periodic review)
• Training alignment guidance linking SOPs to onboarding, initial qualification, and ongoing competency

Sterile Compounding Program and Staff Training Support

Targeted support to establish or stabilize sterile compounding programs, with emphasis on aseptic technique, error-resistant workflows, and ongoing competency consistent with USP <797> expectationsCommon Deliverables:
• Personnel training and qualification framework
• Aseptic technique training support tailored to equipment, engineering, and workflow
• Review and refinement of gowning, gloving, and aseptic practices
• Environmental monitoring program structure and documentation support
• Cleaning and disinfection program alignment, including staff roles and documentation
• Documentation of training, competency, procedural adherence, and the identification and handling of compounding errors and near misses

Quality Management System Support

Development or refinement of quality system elements that promote consistent, safe compounding practiceCommon Deliverables:
• Deviation and investigation process design
• CAPA structure and documentation practices
• Change control for facilities, equipment, formulations, and documents
• Supplier qualification and incoming material controls
• Data integrity practices aligned with ALCOA+ principles

Formulation, Stability, and Testing Support

Support for formulation documentation, beyond-use dating rationale, and appropriate use of quality testing consistent with USP standards and compounding best practicesCommon Deliverables:
• Formula documentation describing composition, process parameters, and quality attributes
• In-process checks and routine quality assessments appropriate to the preparation and setting
• Support for beyond-use dating rationale based on available evidence, risk assessment, and USP criteria
• Development or refinement of internal testing procedures where applicable
• Review and interpretation of laboratory test reports, including trends and out-of-specification results
• Alignment of testing practices with SOPs and batch records

Compounding Facility Design and Build-Out Support

Advisory support for the design or renovation of compounding facilities based on USP standards, sterile compounding science, and state board of pharmacy facility requirements, with emphasis on contamination control and error-resistant workflowsCommon Deliverables:
• Review of architectural plans and proposed layouts for alignment with USP <795>, <797>, <800>, and state board requirements
• Guidance on room classifications, pressure differentials, and material flows
• Workflow and space planning to reduce contamination risk and prevent compounding errors
• Input on environmental controls, equipment placement, and cleaning access
• Pre-operational review prior to state licensure or accreditation