Quality Assurance & Compliance
GxP-grade quality oversight built into every handoff, so inspections are a non-event.
Quality isn't a gate at the end of the supply chain; it's the discipline built into each handoff. Bensen Solutions embeds GxP controls across packaging, storage, and distribution so compliance is continuous rather than rediscovered during an audit.
We strengthen the SOPs, deviation handling, and vendor quality oversight that determine whether an inspection is routine or a crisis.
What this engagement includes
GMP / GDP compliance
Good Manufacturing and Distribution Practice controls across packaging, storage, and transport.
Deviation & CAPA management
Structured handling of deviations with root-cause analysis and corrective/preventive actions that hold.
Temperature excursion management
Excursion assessment, stability-based disposition decisions, and cold-chain qualification.
Audit & inspection readiness
Documentation, mock audits, and preparation so regulatory and sponsor inspections are routine.
SOP development
Clear, usable standard operating procedures that match how work is actually done.
Vendor quality oversight
Quality agreements and ongoing oversight of CMOs, depots, and couriers against defined standards.
How we work
- 1
Assess the system
We review current SOPs, quality agreements, and records against GxP expectations.
- 2
Close the gaps
We remediate procedures, deviation handling, and documentation where they fall short.
- 3
Build readiness
We prepare teams and records so inspections and audits run smoothly.
- 4
Sustain compliance
We embed the cadence and oversight that keep quality continuous, not periodic.
What you can expect
- Inspection-ready documentation at all times
- Faster, cleaner deviation and CAPA resolution
- Temperature excursions handled by a clear playbook
- Vendor quality measured against real agreements
Frequently asked questions
- What is GDP in pharmaceutical distribution?
- Good Distribution Practice (GDP) is the set of quality standards governing how medicinal products are stored, transported, and handled through the distribution chain — covering temperature control, traceability, documentation, and vendor qualification — so product integrity is maintained from release to the patient.
- How is a temperature excursion handled?
- An excursion is quarantined and assessed against the product's stability data to decide whether it remains usable. The event is documented as a deviation, root cause is investigated, and corrective actions are taken — all under defined SOPs so disposition is consistent and defensible.
- How do you prepare for a regulatory inspection?
- Inspection readiness means keeping documentation current and retrievable, ensuring SOPs match actual practice, resolving open deviations and CAPAs, and rehearsing through mock audits — so when an inspector arrives the answers and records are already in order.