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.