Cost Effective GMP API and Supply Chain Audits

RMC expert auditors combine a deep understanding of quality systems and risk management with the investigative skills to bring you meaningful audit results – often at rates that are comparable or lower than your own internal costs.

The RMC Advantage

Cost: With RMC, overall audit costs often prove to be comparable or less than those conducted by your equivalently experienced internal staff. See table below for an example cost comparison.
Flexibility: RMC's expert auditors can be quickly scheduled to meet your needs. We can use our own procedures and templates, or train on your procedures and use your templates -- at no extra cost to you.
Experience: Our auditors each have between 15 and 30 years of global pharmaceutical/biotech experience. We have audited across the US, Canada, Europe, and Asia (including India and China).
Team approach: Our auditors are part of an integrated team and not simply a collection of loosely connected 'consultants' or 'associates'. The assigned auditor has access to the combined experience of the team in the event that unusual situations are encountered.
Leverage: Increasing regulatory expectations for supply chain control means more audits. RMC auditors, with expertise in just the areas you need, will help you over this current hurdle without increasing your permanent headcount.

Example: Cost comparison for a 2-day supplier audit in Shanghai

Item	Internal Auditor Cost	How can RMC be so cost-effective?
Time for travel plus on-site auditing (assume 1 full week)	$3,260¹	RMC can: Use fixed travel time charges that are less than actual—and don't include hidden "extras" like recuperation time Travel economy class regardless of distance* Employ tools and practices that expedite all aspects of preparation and reporting * In this example, economy airfare compared at $1200
Preparation and Reporting (assuming 32 hr max allowance)	$2,608
Airline travel cost (assuming, like most companies, your travel policy requires business class travel for overseas flights)	$12,000²
Total³	$17,868	Estimated cost for an RMC expert audit: $9,600 - $15,200⁴

¹Basis: internal employee auditor with not less than 15 years of pharmaceutical experience representing total annual cost of $150,000 (i.e., salary plus ALL benefits and associated infrastructure costs), or $3260/wk for a 46-work-week year.
² Recently-sampled cost of a business-class air ticket between Chicago and Shanghai.
³ Assumes equivalent incidental travel related expenses that are not included in either the internal auditor or RMC cost estimates.
⁴ Actual cost will depend on experience level of assigned auditor, the scope of the audit and the actual cost of air transportation and other incidental travel expenses.