Why You Have to Have a Quality Agreement With Your Contractor

Why You Have to Have a Quality Agreement With Your Contractor

March 15th, 2013 // 3:10 am @

March 15, 2013

It’s incredibly important to have a quality agreement with any of your contract manufacturers. FDA can ask during an audit to take a look at any documents that describe how any contract service providers at your firm are managed. Also, any changes that are made to the product without approval from the appropriate regulatory body can make the product adulterated or misbranded. Your quality agreement will be an effort to minimize this risk.

Quality Agreement Essentials – Avoid Warning Letter Disasters!

One thing to remember, according to Alan Minsk, Arnall Golden Gregory LLP, that many companies forget in haste, is that the quality agreement needs to be in place well before you do any business or perform any GMP activities. Often, production and processes are begun before the agreement is fully in place. We never want to delay progress, but any confusion or error on quality can lead to major problems and more loss of revenue when expectations are not laid out well in advance.

Know that if a contractor violates GMPs, the contracting company is going to be on the hook with FDA. There have been many recent examples of FDA enforcement because a quality agreement was not properly followed, or something arose because the agreement was not in place.

For example, FDA recently sent FSC Laboratories a warning letter because it did not set up a quality agreement with one of its contract manufacturers. The warning letter stated that the company failed to set up a quality agreement with the contract manufacturer for a nebulizer device. FDA also stated that the responsibilities between FCS and the contractor were not clearly laid out.

FDA investigators also noted that there was not a quality agreement between FSC and one of its contract manufacturers for a drug. FSC replied to FDA, and the agency found the new quality agreement adequate, but, FDA still raised some issues.

FDA noted that the quality plan indicated that product release testing was going to be done by the contractor. But FDA noted that because FCS owned the product, the firm is ultimately responsible for it.

There is no doubt – quality agreements are very important to FDA. According to Ann Meeker O’Connell, acting associate director of FDA, a sponsor needs to indicate what specific responsibilities they are transferring to the contracting company – in writing.

 For a lot more information on avoiding major FDA problems on quality agreements, check out our May 1 Webinar on this topic.


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