Outsource vs In-House HPLC Testing
HPLC is one of the most commonly insourced analytical techniques because methods are well established and volumes in QC are steady. Outsourcing remains common for method development, validation, unusual methods and overflow, or where a GMP quality system cannot yet be supported.
Often kept in-house
- Routine assay and release testing
- In-process testing
- Stability pulls with steady volumes
Often outsourced
- Method development and validation
- Impurity identification (LC-MS)
- Overflow and infrequent methods
Factors to weigh
- Testing volume and how predictable it is
- Equipment capital cost and depreciation (obtain real supplier quotations)
- Operating costs: consumables, gases, reference materials, service contracts
- Staff expertise, training and retention
- Facility requirements: space, utilities, ventilation, environmental control
- Calibration, maintenance and instrument qualification
- Method validation and quality system (e.g. ISO/IEC 17025 if accredited results are needed)
- Turnaround needed versus outside laboratory turnaround plus shipping
- Sample logistics, stability and holding times
- Expected instrument utilization
Common questions
- What quality system is needed for GMP HPLC?
- Qualified instruments, validated methods, controlled data systems and trained analysts under a GMP quality system.
- Is there a volume where in-house pays off?
- There is no universal figure. Compare fully loaded in-house cost — equipment, staff, calibration, consumables, quality overhead — against real outside quotations for your actual annual volume.