After a couple of different pharmaceutical firms received complete response letters from the FDA over the past few months, the editors at Contract Pharma asked me to write some general advice on how pharma firms that use contracted services like manufacturers and clinical sites can avoid running risks stemming from the contracted service and poor records management controls.
You can see my article here:
http://www.contractpharma.com/expertsopinion/2010/02/12/cmos_and_complete_response_letters
In summary, it's been my experience that firms really have two choices, neither of which is particularly easy or 100% perfect:
1.
Write a contract that specifically spells out
how your CMO is to retain records, what records it is to retain, what oversight
and reviews of records your CMO is to conduct, by whom, how often, and so on –
in other words, require in the contract that the CMO implement all the aspects
of what you believe go into a good records retention program for FDA compliance
– and then audit that regularly with dedicated records review due diligence; OR
2.
Expect your CMO to already have an FDA-compliant
records management program in place and conduct your on-site due diligence and
quality system audits to verify compliance with this as it relates to records
relevant to your product and company.
You can get some good advice along with insights into building your own FDA records control programs by taking a look at my recorded seminar on records retention and management for FDA compliance. If you need outside help, consider my private FDA records consulting service.
When it comes to managing critical suppliers' records, if you've got a more ideas than the two I've listed above, I'd love to hear it. Just bear in mind - coming up with good compliance ideas is easy; coming up with enforceable good compliance ideas is definitely a bit more challenging.
