Pharma Company NDA
GDP audit passed first time: 45 instructions in 6 weeks
Situation: An international pharmaceutical company was launching a new temperature-controlled pharmaceutical warehouse. A corporate GDP audit by the UK office was 8 weeks away. The existing Ukrainian OHS documentation met neither local NPAOP requirements nor the HQ's GDP standards.
What we did: We brought in a specialist engineer with 8 years of GMP experience. In 2 weeks we ran an internal audit of the current documents plus a site visit with an inventory of workplaces. In 4 weeks we developed 45 instructions, 12 procedures, evacuation plans and logs. Coordination with the UK QA Manager through a weekly sync.
Result: The GDP audit was passed first time — zero findings. The warehouse was certified and commissioned on schedule. Project cost — UAH 180,000 one-off. Ongoing support — the FULL package, still running (4 years now).
Services involved in the case: OHS audit · Documentation · FULL outsourcing









